LabMedica International July 2024

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AI Accurately Predicts Tumor-Killing Cells

Cellular immunotherapy involves extracting immune cells from a patient’s tumor, potentially enhancing their cancer-fighting capabilities through engineering, and then expanding and reintroducing them into the body. T cells, a primary type of

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Clinical Decision Software a Game-Changer in the Antimicrobial Resistance Battle

Antimicrobial resistance (AMR) is a serious global public health concern that claims millions of lives every year. It primarily results from the inappropriate and excessive use of antibiotics, which reduces the efficacy of treatments for various

infectious diseases, jeopardizing significant medical advancements and substantially inflating healthcare costs. The World Health Organization (WHO) stresses the importance of preventing infections, ensuring universal access to quality diagnostic and treatment

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New Era

in Automated

Tuberculosis Testing

TTransplant Rejection Test

Transplant Rejection Test

Replace Surgical Biopsies

By using T cell exosomes as a biomarker that is significantly altered during the organ rejection process, researchers have developed a breakthrough blood test that can accurately monitor acute cellular rejection (ACR) after an organ transplant.

Test Cuts UTI Detection to 45 Minutes

RA

ntimicrobial Resistance (AMR), is a silent but growing pandemic where bacteria have become resistant to lifesaving antibiotics due to decades of overuse and misuse. In 2019, AMR was responsible for nearly 1.3 million deaths worldwide and is projected to cause 10 million deaths annually by 2050. Urinary Tract Infections

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uberculosis (TB) is responsible for 1.3 million deaths every year, positioning it as one of the top killers globally due to a single infectious agent. In 2022, around 10.6 million people were diagnosed with TB, and it’s estimated that as many as one-quarter of the global population may be infected with Mycobacterium tuberculosis (MTB). Effective TB control requires healthcare pro-

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Pre-Dementia Alzheimer’s Test

Alzheimer’s disease is well known for its slow development over many years, which typically leads to treatment interventions only after the disease has advanced to stages where it may be nearly impossible to slow down its progression. The results of a groundbreaking study, recently published in the journal Nature Communications, have offered new hope for not

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espiratory tract infections, predominantly caused by viral pathogens, are a common reason for healthcare visits. Accurate and swift diagnosis of these infections is essential for optimal patient management. In light of the COVID-19 pandemic,

there have been significant advancements in laboratory medicine, enhancing the testing capabilities for respiratory viruses. These advancements include the use of diverse sample types and the introduction of various new testing methods. However, these

Image: Human cells secreting exosomes, illustration (Adobe Stock)

STREAMLINE YOUR QC, THE SMART WAY INTRODUCING ACUSERA SMART

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The Smart QC workflow minimizes the potential for human error by reducing the operator handling time.

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CONVENIENT DESIGN

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options, and fostering innovation in surveillance and research as critical strategies to combat AMR in human health. In a significant stride towards preventing AMR, a groundbreaking medical device has been developed to accurately differentiate between viral and bacterial infections, thereby assisting doctors in administering precise and effective treatment.

Developed by Smart Blood Analytics Swiss (Zürich, Switzerland; www.sba-swiss.com), the VIRUS vs. BACTERIA Clinical Decision Support Software utilizes just 17 routine blood parameters, biological sex, and age to effectively distinguish between viral and bacterial infections. With routine blood testing widely available globally, VIRUS vs. BACTERIA significantly enhances the ability of physicians to differentiate between viral and bacterial infections and supports the rational use of antibiotics, particularly in scenarios where traditional blood markers have limited diagnostic value.

The VIRUS vs. BACTERIA Clinical Decision Support Software has been awarded EU-MDR (European Medical Device Regulation) certification. As the healthcare sector continues to confront challenges that demand innovative responses, VIRUS vs. BACTERIA represents a promising solution. With its global availability, user-friendly interface, and robust capabilities, this advanced tool is well-positioned to empower healthcare professionals in their ongoing fight against AMR.

“This achievement shows our commitment to advancing healthcare through innovation,” said Dr. Marko Notar, CEO of Smart Blood Analytics Swiss. “By providing clinicians with a precise tool to differentiate between viral and bacterial infections, we aim to empower doctors with more information and help them in their decision of antibiotic prescriptions. This contributes to more effective healthcare practices.”

Image: The clinical decision support software differentiates between viral and bacterial infections (Photo courtesy of Smart Blood Analytics)

AI Tool Precisely Matches Cancer Drugs to Patients, Using Information from Each Tumor Cell

Current strategies for matching cancer patients with specific treatments often depend on bulk sequencing of tumor DNA and RNA, which provides an average profile from all cells within a tumor sample. However, tumors are heterogeneous, containing multiple subpopulations of cells, or clones, each potentially responding differently to treatments. This variability may explain why some patients either fail to respond to certain treatments or develop resistance. Single-cell RNA sequencing offers higher-resolution data than bulk sequencing, capturing data at the single-cell level. This approach to identify and target individual clones may lead to more lasting drug responses, although, single-cell gene expression data are more expensive to generate and less accessible in clinical environments.

In a proof-of-concept study published in Nature Cancer, researchers at the National Institutes of Health (NIH, Bethesda, MD, US; www.nih.gov) have developed an artificial intelligence (AI) tool that leverages data from individual tumor cells to predict how well a person’s cancer might respond to a specific drug. This study demonstrates the potential of single-cell RNA sequencing in helping oncologists match effective therapies to their patients. In the new study, the team employed a machine learning

technique known as transfer learning to train an AI model using common bulk RNA sequencing data, after which they used single-cell RNA sequencing data to fine-tune the model. This method was applied to existing cell-line data from comprehensive drug response trials, resulting in AI models for 44 FDA-approved cancer drugs that could predict cellular reactions to both individual and drug combinations.

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Graham

Hernán

Argentina

Bernard Gouget France

Maurizio Ferrari Italy

Tahir S. Pillay South Africa

Andreas Rothstein Colombia

Praveen Sharma India

Rosa I. Sierra-Amor Mexico

Peter Wilding United States

Andrew Wootton United Kingdom

LabMedica lnternational is published eight times a year and is circuIated worldwide (outside the USA and Canada) without charge and by written request, to clinical laboratory specialists and administrators, and other qualified professionals allied to the field.

To all others: Paid Subscription is available for a two-year subscription charge of US$120. Single copy price is US$20. Mail your paid subscription order accompanied with payment to Globetech Media, P.O.B. 800222, Miami, FL 33280-0222. For change of address or questions on your subscription, write to: LabMedica lnternational, Circulation Services at above address; or visit: www.LinkXpress.com

Image: A false color scanning election micrograph of lung cancer cells grown in culture (Photo courtesy of Anne Weston)

New Era in Automated Tuberculosis Testing

viders to address not only those with active TB but also the vast, often unnoticed reservoir of individuals with latent TB infection (LTBI). Screening for latent TB involves identifying and testing people at risk of contracting TB or those who might progress from latent to active TB. Now, a unique blood-based interferon-gamma release assay (IGRA) paired with an automated liquid handling platform enables accurate TB testing and streamlined lab workflows without compromising on clinical performance.

Revvity, Inc. (Waltham, MA, USA; www.revvity.com) has introduced the T-SPOT.TB test for use on the Auto-Pure 2400 liquid handler from Allsheng (Hangzhou, China; www.allsheng. com). This test is an interferon-gamma release assay (IGRA) that uses enzyme-linked immunospot (ELISPOT) technology for the detection of LTBI. This technology involves crucial steps recognized by the World Health Organization as vital for ensuring dependable and accurate TB testing results. These critical steps include washing, isolating, and counting peripheral blood mononuclear cells (PBMCs) before performing the test.

The integration of the T-SPOT.TB test’s accuracy with the efficiency of the Auto-Pure 2400 creates a robust solution benefiting laboratories, clinicians, and ultimately patients. The Auto-Pure 2400, an automated liquid handling platform, features integrated magnetic cell isolation technology, and simplicity of use, and is designed

AI Tool Precisely Matches Cancer Drugs to Patients

Using Information from Each Tumor Cell

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Further testing involved data from 41 multiple myeloma patients treated with four drugs and 33 breast cancer patients treated with two drugs. The findings revealed that resistance in any single-cell clone could render the treatment ineffective, even if other clones were responsive. The model also successfully predicted resistance development in data from 24 patients with non-small cell lung cancer undergoing targeted therapies. The researchers noted that the accuracy of this approach can improve as single-cell RNA sequencing becomes more widely available. To facilitate broader use, the researchers have created a research website and a guide, dubbed Personalized Single-Cell Expressionbased Planning for Treatments In Oncology (PERCEPTION), for applying the AI model to new datasets.

to enhance laboratory workflows. It can process up to 24 samples per run and completes day-1 T-SPOT.TB workflows in less than 3.5 hours with just one mid-run user interaction required. This system not only streamlines laboratory processes but also includes an intuitive software interface, making it user-friendly.

“The ability to use the Auto-Pure 2400 platform with our T-SPOT.TB test provides labs an efficient workflow allowing latent TB testing to be run in a mid-high-volume setting, without having to compromise on the clinical performance of the test,” said Darren Sher, general manager, infectious diseases for Revvity. “With this solution, more labs can offer clinicians access to the most accurate TB diagnostic on the market.”

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Image: The T-SPOT.TB test is now paired with the Auto-Pure 2400 liquid handling platform for accurate TB testing (Photo courtesy of Shutterstock)

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The LightCycler 480 System is a proven high-performance, medium-to high-throughput PCR platform that provides various methods for gene detection, gene expression analysis, genetic variation analysis, and array data validation.

AI Accurately Predicts Tumor-Killing Cells

white blood cell or lymphocyte, circulate in the blood and monitor for virally infected or cancerous cells. Among these, T cells that infiltrate solid tumors are known as tumor-infiltrating lymphocytes, or TILs. However, not all TILs effectively recognize and attack tumor cells. To address this, scientists have now employed artificial intelligence (AI) to create a predictive model that can identify the most effective TILs for use in cancer immunotherapy.

The new AI-driven predictive model, called TRTpred developed by scientists at Ludwig Cancer Research (New York, NY, USA; www. ludwigcancerresearch.org) ranks T cell receptors (TCRs) according to their tumor reactivity. To create TRTpred, the researchers utilized 235 TCRs from patients with metastatic melanoma, already categorized as tumor-reactive or non-reactive. They input the global gene-expression profiles of the T cells harboring each TCR into a machine learning model to identify patterns distinguishing tumor-reactive T cells from their inactive counterparts. This model, enhanced with additional algorithms, supports personalized cancer treatments tailored to the unique cellular composition of each patient’s tumors.

The TRTpred model was used to analyze TILs from 42 patients with melanoma, gastrointestinal, lung, and breast cancer, pinpointing tumor-reactive TCRs with about 90% accuracy. The selection process was further refined using a secondary algorithmic filter to isolate those T cells with “high avidity”—meaning they bind strongly to tumor antigens. It was observed that T cells identified by TRTpred and this secondary filter as both tumor-reactive and high avidity were predominantly located within the tumors rather than in the surrounding stromal tissue. This aligns with previous studies suggesting that effective T cells often deeply penetrate tumor islets.

A third filter was then introduced to enhance the identification of TCRs recognizing a diverse array of tumor antigens. This filter groups TCRs based on similar physical and chemical characteristics, assuming TCRs in each group recognize the same antigen. This enhanced system, named MixTRTpred, was then tested by growing human tumors in mice, extracting TCRs from their TILs, and employing MixTRTpred to identify T cells that were tumor-reactive, had high avidity, and targeted multiple tumor antigens. The researchers then engineered mouse T cells to express these TCRs and demonstrated that these modified cells could effectively eradicate tumors when reintroduced into the mice.

“The implementation of artificial intelligence in cellular therapy is new and may be a game-changer, offering new clinical options to patients,” said Ludwig Lausanne’s Alexandre Harari, who led the study published on May 7, 2024 in Nature Biotechnology.

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Multiplex PCR Test Identifies 95% of Sepsis-Causing Pathogens

Sepsis contributes to one in every three hospital deaths in the US, and globally, septic shock carries a mortality rate of 3040%. Diagnosing sepsis early is challenging due to its non-specific symptoms that can be easily overlooked. Currently, the main method for sepsis testing involves complex blood culture tests that can take days to yield results. This approach, which has been standard for over 40 years, is only able to detect ‘viable’ organisms, thus missing a broader range of potential microbial analytes present in the blood. Now, a groundbreaking diagnostic system currently under development could revolutionize life-saving clinical decision-making for sepsis patients. Deepull (Barcelona, Spain; deepull.com) has unveiled its UllCORE benchtop diagnostic system that is capable of delivering 50 reportable results within an hour. This system covers 95% of pathogens known to cause sepsis, including resistance genes. The real-time multiplex PCR system operates by extracting total microbial DNA from an 8 mL sample of whole blood, bypassing the traditional and time-consuming blood culture process. The UllCORE assay encompasses a broad array of bacterial targets, fungi, and genes that create antibiotic resistance, enhancing the ability of clinicians to make more informed decisions faster. This rapid and sensitive technology aims to reduce the risks associated with inappropriate antibiotic use, thereby aiding in the battle against antimicrobial resistance in hospital settings.

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Image: The AI predictive model identifies the most potent cancer killing immune cells for use in immunotherapies (Photo courtesy of Shutterstock) Cont’d on page

The Most Clinically Advanced Critical Care Test Menu Now Includes

Prime Plus provides the most clinical value of any blood gas/critical care analyzer profile by adding essential tests for kidney function (BUN, Creatinine, eGFR), plasma volume (ePV), ionized magnesium (iMg) and MCHC.

Creatinine, eGFR, and BUN

Over 50% of patients admitted to the ICU develop some degree of acute kidney injury.1 Creatinine, eGFR, and BUN monitoring provides indication of changes in kidney function and helps guide therapy to prevent AKI.

Estimated Plasma Volume (ePV)

The plasma volume status of a patient is one of the top priorities in evaluating and treating critical illness including CHF, ARDS, AKI, and Sepsis.2-4

Ionized Magnesium (iMg)

Hypomagnesemia is a frequent finding in critically ill patients.5 Magnesium therapy guided by real time ionized magnesium monitoring has been shown to improve outcome in these patients.6

Mean Corpuscular Hemoglobin Concentration (MCHC)

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Pre-Dementia Alzheimer’s Test

only earlier diagnosis but also for potentially slowing the course of Alzheimer’s disease.

A team of researchers from Aarhus University (Aarhus, Denmark; www.au.dk) has identified a specific receptor found on immune cells that can bind and neutralize harmful “beta proteins”, which are closely linked with the development of Alzheimer’s disease. The study underscores the significant role that the peripheral immune system may play in defending the body against Alzheimer’s by preventing the build-up of these harmful proteins in the brain. This discovery paves the way for detecting the disease-related changes much earlier than current methodologies allow. Earlier activation of the body’s immune response could potentially slow the progression of the disease well before it develops into severe dementia.

This innovative approach employs an advanced blood test analysis highly sensitive to the early stages of Alzheimer’s disease. This marks a significant advancement over existing diagnostic tools like PET scans, which typically detect the disease only at more advanced stages. The study has garnered international attention, prompting the research team to plan further projects to validate this new method in a broader patient cohort. Additionally, the team is investigating the exact mechanisms

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before it develops into dementia (Photo courtesy of 123RF)

by which the immune system combats the early signs of Alzheimer’s, hoping to develop even more effective treatments in the future.

“Our hope is that these discoveries can pave the way for new strategies in the fight against Alzheimer’s. By understanding how the immune system can be mobilized against early stages of the disease, we might be able to develop therapies that can intervene much earlier than current treatment options,” said Kristian Juul-Madsen, postdoc at the Department of Biomedicine, Aarhus University, and one of the researchers behind the study.

Multiplex PCR Test Identifies 95% of Sepsis-Causing Pathogens

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Preliminary results of the assay based on prospectively obtained specimens from patients with sepsis have shown high agreement with positive blood culture results. Remarkably, it has also been able to identify over twice the number of clinically relevant pathogens as compared to traditional blood cultures. While the focus is currently on sepsis, Deepull envisions broad applications for the UllCORE system in diagnosing a variety of acute infections. Deepull is actively seeking to build strong partnerships with hospitals and laboratories as it prepares to launch clinical trials in 2025.

“Introducing the UllCORE platform and its unique capabilities to the market is a significant milestone for deepull,” said Jordi Carrera, Chief Executive Officer and Co-Founder of deepull. “We are encouraged by early results based on prospectively obtained specimens from septic patients and look forward to initiating clinical trials next year, as well as refining the platform ahead of commercial launch. We believe our UllCORE system could transform the standard of care for sepsis diagnosis, for the benefit of patients globally.”

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Image: Researchers have found a way to spot the debilitating disease Alzheimer’s

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Test Cuts UTI Detection to 45 Minutes

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(UTIs) are among the most prevalent bacterial infections, with 50-60% of women experiencing a UTI in their lifetime, and one in ten women aged 18 and over-reporting at least one presumed UTI each year. Moreover, up to half of the bacteria causing these infections have developed resistance to at least one antibiotic. Now, a groundbreaking test promises to revolutionize UTI treatment by bringing advanced laboratory testing capabilities directly into the doctor’s office.

The PA-100 AST System, developed by Sysmex Astrego AB (Uppsala, Sweden; www.sysmex-astrego.se), is a cutting-edge diagnostic tool that can detect a bacterial infection in just 15 minutes and determine the appropriate antibiotic for treatment within 45 minutes. This system utilizes a small (400 microliter/less than half a milliliter) urine sample placed on a smartphone-sized cartridge. The cartridge, equipped with a nanofluidic chip, is loaded into an analyzer unit roughly the size of a shoebox, which then reads the sample at a cellular level. Designed for use in doctor’s offices, the analyzer is fully automatic and requires no maintenance. Its rapid testing capability is a significant improvement over traditional methods, which can take days to culture bacteria and determine antimicrobial susceptibility. This rapid, accurate diagnosis of bacterial infections enables doctors and healthcare workers to precisely target antibiotic use, which will help curb the spread of antibiotic-resistant infections, enhancing healthcare and saving lives.

This represents the first time a point-of-care test can identify specific infections and their susceptibility to particular antibiotics by monitoring how an infection responds to various drugs in real time (a phenotypic test). It supports doctors and health workers in their clinical decision-making at the point of care and opens up the significant possibility of previously “retired” first-line antibiotics coming back into use for the majority of patients. Roughly 25-30% of patients have infections resistant to older first-line antibiotics which have been retired as a result; this means the remaining 7075% of patients could still benefit from those older drugs. Since the PA-100 AST System identifies which specific antibiotic can treat an infection, it will likely allow retired antibiotics to be brought back into service because the test is able to demonstrate when an infection is susceptible to their effects.

The PA-100 AST System envisions a future where patients receive quick, accurate diagnoses and appropriate treatments during a single doctor’s visit. Sysmex Astrego recently received one of the

RESPIRATORY SYNCYTIAL VIRUS TEST ABBOTT DIAGNOSTICS

BinaxNOW RSV Card is an in vitro rapid immunochromatographic assay used to detect respiratory syncytial virus (RSV) fusion protein antigen in nasal wash and nasopharyngeal (NP) swab specimens from symptomatic patients.

UK’s most prestigious science awards, the “Longitude Prize on AMR,” for developing the PA-100 AST System, which was launched in the European market in June 2023. The Longitude Prize on AMR was established in 2014 to encourage the development of new diagnostic tests that can quickly determine if an infection is bacterial and identify the correct antibiotic, thereby reducing the typical 2-3 day lab test delay and ending the prevalent “just in case” prescribing that contributes to the rise of antibiotic resistance. This award-winning test paves the way for future technologies that could transform how infections are diagnosed and treated, extending beyond UTIs to potentially include blood and sputum tests for other infections.

“The PA-100 AST System challenges bacteria present in a patient’s urine with microscopic quantities of antibiotics in tiny channels embedded in a cartridge the size of a smartphone. We rapidly pinpoint whether a bacterial infection is present and identify which antibiotic will actually kill the bugs, guiding doctors only to prescribe antibiotics that will be effective,” said Mikael Olsson, CEO and co-founder, Sysmex Astrego. “We have already started rolling out the test in Europe, we’re running studies in surgeries across the UK and working with regulators to secure additional approvals. The GBP 8 million prize will support us to tailor the test for use with different kinds of UTIs and antibiotics, speeding up access for more patients.”

Image: The PA-100 AST System for rapid AMR detection has won the “Longitude Prize on AMR” (Photo courtesy of Sysmex Astrego)

Organ Transplant Rejection Test Could Replace Surgical Biopsies

Transplanted organs constantly face the risk of being rejected by the recipient’s immune system which differentiates self from non-self using T cells and B cells. T cells are commonly associated with acute cellular rejection (ACR), where T cells attack the transplanted organ. To counteract this, organ transplant recipients must take immunosuppressive drugs indefinitely. Despite this, rejection episodes can still occur, necessitating long-term monitoring. Currently, ACR detection in transplant patients requires repeated surgical biopsies throughout their lives. These biopsies are vital for monitoring ACR and adjusting treatments accordingly, yet they diminish the patient’s quality of life and can cause severe complications. Now, the discovery of a promising biomarker has paved the way for a blood test for ACR.

Researchers at Yale School of Medicine (New Haven, CT, USA; www.medicine.yale.edu) have achieved a potential breakthrough in monitoring ACR via blood tests by focusing on T cell exosomes, which are significantly altered during ACR. These extracellular vesicles play a crucial role in cell communication and transport various proteins and RNAs. Although T cells themselves do not show detectable changes in the bloodstream during ACR, their exosomes do. Isolating these exosomes for study presents challenges due to the mixture of exosomes from various cells in the blood. The research team has developed a method to enrich T cell exosomes from blood samples, providing detailed insights into the changes in their cargo during ACR. Using advanced techniques like RT-qPCR for RNA and western blot for protein analysis, they have identified significant differences in T cell exosomes from mouse models of heart transplantation undergoing ACR.

This methodology was also applied to human heart transplant patients, confirming similar alterations in T cell exosomes in the case of ACR patients. The study demonstrates that T cell exosomes not only indicate the occurrence of ACR but may also contribute to the damage in transplant rejection. The ongoing research aims to validate this biomarker in a larger cohort of heart transplant recipients and to extend the findings to lung transplant monitoring. Ultimately, this could lead to replacing invasive surgical biopsies with a simple blood test for detecting ACR, enhancing the quality of life and potentially saving more lives by facilitating timely interventions.

AI Detects Viable Tumor Cells for Accurate Bone Cancer Prognoses Post Chemotherapy

Osteosarcoma, the most common malignant bone tumor, has seen improved survival rates with surgery and chemotherapy for localized cases. Yet, the prognosis for advanced metastatic osteosarcoma remains grim. Traditional post-treatment prognosis methods, based on assessing necrosis or evaluating the proportion of dead tissue within the tumor, suffer from inter-observer variability and might not accurately predict treatment response. Researchers have now developed and validated a machine-learning model capable of accurately evaluating the density of surviving tumor cells in osteosarcoma pathological images, offering a more reliable prognosis prediction.

The model, developed by researchers at Kyushu University (Fukuoka, Japan; www.kyushu-u.ac.jp), uses deep-learning algorithms to identify viable tumor cells within pathological images, matching the assessment skills of expert pathologists. This approach overcomes the limitations of the traditional method for necrosis rate assessment, which calculates the necrotic area without considering individual cell count, leading to inconsistent evaluations across pathologists and inadequate reflection of chemotherapy effects. In phase 1 of the study, the team trained the deep-learning model to detect surviving tumor cells and validated its performance using patient data. The AI model was as proficient in detecting viable tumor cells in pathological images as expert pathologists.

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transplant (Photo courtesy of Nicolas Primola).

“I’m imagining a future in which a heart transplant patient could go once a month to a local [diagnostics] lab,” said Prashanth Vallabhajosyula, MD, MS, associate professor of surgery (cardiac) and the principal investigator of the study, which was published in the American Journal of Transplantation. “They don’t have to come to a cath lab and get a biopsy of their transplanted heart. They just go to a local lab, give a blood sample, and go home, and clinicians would receive molecular information about the overall immune health of the transplanted heart.”

Image: Exosomes can be a promising biomarker for cellular rejection after organ

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AI Detects Viable Tumor Cells for Accurate Bone Cancer Prognoses Post Chemotherapy

In phase 2, the researchers focused on diseasespecific survival and metastasis-free survival. While disease-specific survival tracks the duration after diagnosis or treatment without death directly caused by the disease, metastasis-free survival monitors the time post-treatment without cancer cells spreading to distant body parts. They also examined the correlation between AI-estimated viable tumor cell density and prognosis. The findings revealed that the AI model’s detection performance and precision were comparable to that of the pathologist, accompanied by good reproducibility. The team then divided the patients into groups based on whether the viable tumor cell density was above or below 400/mm2. They found that a higher density

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correlated with a poorer prognosis, while a lower density indicated a better outcome.

The team found that the necrosis rate was not associated with disease-specific survival or metastasis-free survival. Further analysis of individual cases showed that AI-estimated viable tumor cell density is a more reliable predictor of prognosis than necrosis rate. These findings suggest that by incorporating AI in pathological image analysis, this method enhances detection accuracy, minimizes variability among assessors, and offers prompt evaluations. Estimating viable tumor cell density, which indicates the cells’ proliferation potential postchemotherapy, emerges as a superior indicator of treatment efficacy over traditional necrosis rate assessment. This AI model promises significant advancements in clinical settings after broader validation to facilitate its widespread application.

“This new approach has the potential to enhance the accuracy of prognoses for osteosarcoma patients treated with chemotherapy,” said Dr. Makoto Endo, a lecturer of Orthopedic Surgery at Kyushu University Hospital. “In the future, we intend to actively apply AI to rare diseases such as osteosarcoma, which have seen limited advancements in epidemiology, pathogenesis, and etiology. Despite the passage of decades, particularly in treatment strategies, substantial progress remains elusive. By putting AI to the problem, this might finally change.”

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New Guidelines for Respiratory Viral Infection Testing

developments have also created a need for greater educational efforts on how best to utilize these novel testing options. Addressing this need, a new guidance document has been released, offering expert advice on essential aspects of clinical testing for respiratory viral infections, aiming to maximize the benefits of recent technological advances in this rapidly evolving field.

This guidance has been formed by a multidisciplinary team of clinical microbiologists and infectious disease clinicians convened by the Association for Diagnostics & Laboratory Medicine (ADLM, formerly AACC, Washington, D.C., USA; www.myadlm.org), with endorsement from the Pan American Society for Clinical Virology. Reflecting the latest insights from COVID-19 and other respiratory virus research, the document advocates for the use of nasopharyngeal samples for upper respiratory tract infections and suggests employing nucleic acid amplification testing whenever feasible. It emphasizes that the interpretation of viral load results should be considered alongside clinical symptoms.

Moreover, the guidance underlines the importance of diagnostic stewardship in respiratory virus testing, which is crucial for ensuring accurate, clinically relevant outcomes while also conserving laboratory resources. The document also introduces a decision-making algorithm designed to help laboratories identify the most suitable tests for specific cases of respiratory virus infection. This algorithm takes into account whether patients are symptomatic, immunocompromised, and whether a positive test result would alter disease management strategies.

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Image: The new ADLM guidance will help healthcare professionals navigate respiratory virus testing in a post-COVID world (Photo courtesy of 123RF)

“The current guidance document is the authors’ expert opinion based on the preponderance of available evidence to address key questions related to best practices for laboratory diagnosis of respiratory viral infections,” wrote the guidance document authors Drs. Gregory J. Berry, Tulip A. Jhaveri, Paige M.K. Larkin, Heba Mostafa, and N. Esther Babady. “Laboratorians should remain alert and involved to provide guidance on managing testing and the information obtained from a wider range of testing settings.”

Use of DICOM Images for Pathology Diagnostics Marks Significant Step towards Standardization

igital pathology is rapidly becoming a key aspect of modern healthcare, transforming the practice of pathology as laboratories worldwide adopt this advanced technology. Digital pathology systems allow for the immediate and remote access to digital images of tissue samples, moving away from traditional physical glass slides that require microscope examination. The COVID-19 pandemic underscored the importance and utility of remote capabilities in pathology, significantly accelerating the adoption of digital pathology in the U.S. and boosting its market growth internationally.

Now, Sectra’s (Linköping, Sweden; www.medical.sectra.com) digital pathology solution, along with Leica Biosystems’ (Nussloch, Germany; www.leicabiosystems.com) Aperio GT 450 DX, has received

a 510(k) clearance by the US Food & Drug Administration (FDA). This marks the first FDA clearance within digital pathology that allows DICOM images to be used for pathology diagnostics and is a significant step towards standardization in this field. The Aperio GT 450, previously available under enforcement discretion due to the pandemic, is a well-established technology that delivers high-quality images at a fast turnaround time of less than 32 seconds per slide.

Leica Biosystems is not new to the regulated system market; the company boasts 25 years of experience in the digital pathology sector, where it has been integral in implementing, integrating, and innovating technologies that enhance cancer diagnosis and patient care. Sectra’s digital

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Use of DICOM Images for Pathology Diagnostics Marks Significant Step Towards Standardization

Cont’d from page 14

pathology solution is part of its broader enterprise imaging solution, designed to support a comprehensive approach to all imaging needs while reducing operational costs. This scalable and modular solution, centered around a versatile vendor-neutral archive (VNA), enables healthcare providers to grow from ology to ology and from enterprise to enterprise.

“There is no better time for laboratories to optimize their workflow with digital,” said Naveen Chandra, Vice President and General Manager of Digital Pathology at Leica Biosystems. “Today, clinicians are faced with having to do more with less – digital pathology enables them to maintain a high standard of quality with world class images and a fast turnaround time, for the best patient care possible.”

“Sectra has a strong track record of promoting and enabling open integrations and of pushing the development towards standardization within medical imaging IT. The recent FDA clearance including the clearance to utilize DICOM images for pathology diagnostics therefore makes me very proud,” said Dr. Torbjörn Kronander, CEO and President Sectra AB. “Due to the unique nature of the images used in digital pathology, proprietary formats have previously dominated. This FDA approval, including DICOM, shows that standardization

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is possible also within pathology. This is an important first step to a reality where healthcare providers can start reaping the benefits of a larger degree of freedom in choosing what hardware and software to combine, within pathology. This has the potential to increase workflow efficiency, facilitate the adoption of new technology and in the end— benefit patient care.”

Low-Cost Point-of-Care Diagnostic to Expand Access to STI Testing

onorrhea ranks as the second most commonly reported bacterial sexually transmitted infection (STI), with around 82 million global cases in 2020. The infection can lead to severe health consequences like pelvic inflammatory disease, chronic pelvic pain, and infertility. Many patients may not show symptoms, leading to underreported cases and highlighting the need for more accessible, accurate, and cost-effective diagnostic solutions. Now, a new point-ofcare test aims to expand access to STI testing by providing affordable, accurate, and convenient diagnosis.

Scout (Santa Clara, CA, USA; www.scouthealth.com) is developing the STI Scout test to identify and distinguish between Neisseria gonorrhoeae (Ng) and Chlamydia trachomatis (Ct). This new test delivers results in just 30 minutes at a cost expected to be less than half that of current testing methods. STI Scout can use either first void urine samples or vaginal swabs. The test runs on the Scout Hub device and is integrated with the Scout Connect mobile app, which guides users through the testing process, records results, and will eventually link patients to healthcare providers. Future developments aim to include

features that could recommend specific treatments for gonorrhea based on antibiotic resistance.

Scout's innovative test is powered by their patented Loop-de-Loop chemistry, an isothermal technology previously validated for highly accurate SARS-CoV-2 detection. This technology is part of Scout's system currently holding FDA Emergency Use Authorization for point-of-care application, with additional over-the-counter (OTC) use pending. CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator) has awarded Scout USD 1 million to demonstrate proofof-concept and feasibility ahead of developing STI Scout. This funding will support the expansion of Scout's testing menu to offer at-home STI testing, as well as facilitate deployment in point-of-care settings like STI clinics and urgent care centers.

"Our goal is to improve access to accurate diagnostics for everyone. Scout's approach benefits clinicians and patients by providing timely, accurate results which can lead to earlier diagnosis and treatment of patients. Importantly, Scout also could assist healthcare providers in de-

Image: The Aperio GT 450 DX has received US FDA 510(k) clearance (Photo courtesy of Leica Biosystems)

Blood Test Measures Immune Response to Epstein-Barr Virus in MS Patients

Multiple sclerosis (MS) is a chronic neurological condition for which there is currently no cure. It affects around three million people globally and ranks as the second most common cause of disability among young adults. The urgent need for improved treatments has led to extensive research into various viruses associated with MS, with the Epstein-Barr Virus (EBV) emerging as a significant risk factor for the disease. It remains unclear why certain individuals with MS exhibit an abnormal immune response to EBV, which typically causes no symptoms in most people. Now, a novel blood test has been developed that measures the immune response to EBV, providing new avenues for basic research into EBV’s role in MS and potential applications in clinical trials aimed at targeting the virus.

Researchers at Trinity College Dublin (Dublin, Ireland; www.tcd.ie) conducted studies measuring the immune response of MS patients to EBNA-1, a component of EBV that resembles the myelin sheath of nerves, which is the primary target of the immune attack in MS. They discovered that this immune response is heightened in MS patients compared to individuals with epilepsy or healthy controls. The research also indicated that this response is influenced by existing MS medications that suppress the immune system but do not specifically target the virus. They noted that the immune response to EBNA-1 was reduced in MS patients who are on B-cell depleting medications, aligning with levels seen in healthy controls, compared to those not on any medication.

B-cell depleting therapies are known to decrease MS activity, though the precise mechanism is not fully understood. It is hypothesized that these medications may reduce EBV levels, which can reside dormant within B cells. The study did not confirm this hypothesis but did illustrate that immune responses to EBV in MS patients treated with these medications are comparable to those in healthy individuals. The researchers argue that this underscores the potential benefits of selectively targeting EBV rather than broadly suppressing all B

cells, given B cells’ crucial role in fighting infections and the risks of broader immune suppression. This research is groundbreaking as it is the first to use standard hospital laboratory equipment to assess the immune response to EBNA-1 using whole blood samples. This method contrasts with previous studies that required extensive sample preparation in specialized research labs.

The simplicity of the new test demonstrates its potential for broader application and scalability without the need for specialized equipment or additional staff. This development is significant as it enables the standard blood test, processed in a hospital lab, to provide vital insights into the immune system’s response to EBNA-1, which is central to MS’s pathogenesis. The scalability of this test, based on existing diagnostic techniques, opens up possibilities for further basic research into EBV’s biology in relation to MS. Moreover, this test could be used in clinical trials targeting the virus, allowing for the direct measurement of the immune response to potential antiviral treatments rather than solely focusing on MSrelated outcomes.

“In the short term the benefit of this research is likely to be for the research community in MS,” said Dr. Hugh Kearney, Neurologist, School of Medicine, Trinity College. “We believe the approach adopted in this test that uses whole blood samples on a robust hospital-based platform will facilitate adoption in other centers and also replication of the results with a view towards validation. In the medium term, if validated, then this would be of benefit to researchers involved in clinical trials in MS. Long term benefits will be for people with MS, who live with a chronic neurological illness as new treatments tested in clinical trials have the potential to reduce the burden of this potentially disabling disease.”

Low-Cost Point-of-Care Diagnostic to Expand Access to STI Testing

Cont’d from page 17

termining which treatments are appropriate for the patient and can assist combating the spread of antibiotic resistance bacteria" said Cam Ball, PhD, Scout CTO and Co-Founder.

"There is a need for affordable, accurate, and easy-to-use tests that expand access to testing for and proper treatment of Neisseria gonorrhoeae to urgent care centers, STI

clinics, and the like", said Erin Duffy, PhD, R&D Chief of CARB-X. "Given the prevalence of gonorrhea globally, and the growing prevalence of drug-resistant gonorrhea, to diagnose quickly and affordably would allow physicians at all levels of the healthcare system to treat rapidly with the most appropriate therapy. The impact of a test like Scout's could be vast."

Image: The novel test uses an existing diagnostic procedure as its basis to target the Epstein Barr Virus (Photo courtesy of 123RF)

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Patch Detects Skin Cancer Earlier

earable bioelectronics has emerged as a significant innovation in healthcare, especially in the field of biosensing, providing a new method to monitor individual health for both diagnostic and therapeutic purposes. Despite its advancements, there has been a lack of progress specifically in the area of cancer, and more notably in skin cancer detection. Researchers have now introduced a novel technique for identifying malignant melanoma, which is the most serious type of skin cancer and also the fastest growing.

A groundbreaking study conducted by researchers at Karolinska Institutet (Stockholm, Sweden; ki.se) led to the development of a new type of patch equipped with microneedles designed to detect the biomarker tyrosinase directly within the skin. Tyrosinase is an enzyme that serves as a crucial biomarker for malignant melanoma. By assessing the en-

zyme directly in the skin, this approach allows for the rapid detection of changes indicative of the disease. The feasibility of this transdermal microneedle sensor for directly quantifying tyrosinase has been demonstrated in an ex vivo skin model.

In their research, scientists employed human tissue samples from healthy individuals. They applied tyrosinase to these samples to simulate the presence of skin cancer. Their findings suggest that this new patch could serve as an effective alternative to traditional diagnostic techniques, facilitating earlier detection and treatment of malignant melanoma. The researchers are optimistic that their invention will reduce the need for invasive procedures and enhance the quality of life for patients. This innovation marks a significant step forward in improving skin health monitoring and could potentially be adapted to detect other biomarkers simply by altering its design.

The GCM-12 high-speed microcentrifuge offers a large LCD display with accurate control, a brushless DC motor, pulse operation for quick spins, high centrifugal force, interlocking safety lid, quiet running, and more.

“Our method is less invasive and has the potential to provide faster and more reliable results compared to traditional biopsies,” said Onur Parlak, Associate Professor at Karolinska Institutet. “Our goal is to continue developing and improving this technique to offer more accurate and painless diagnostics.”

Novel Shelf-Stable, Easy-to-Use Tests Bring Lab-Level Precision at POC

One of the most critical measurements in healthcare is the blood cell count, which can provide insights into a range of conditions from infections and autoimmune diseases to cancer. Traditionally, collecting a sample for this test involves a blood draw that must be performed at a clinic and analyzed in a centralized clinical laboratory. This requirement can be a significant barrier for homebound individuals or those living in remote areas. Now, researchers have simplified the process to just a finger prick, with blood collected on a paper-dried blood spot card that can be mailed to a lab for analysis, including measurement of white blood cell counts.

Researchers at Tufts University (Medford, MA, USA; www.tufts.edu) are developing

methods to perform these tests that significantly reduce costs and increase accessibility. They are utilizing a widely available resource: paper. Their groundbreaking paper-based tests for personal health monitoring do away with the need for costly lab equipment and can be used by anyone, anywhere. These paper analytical devices are inexpensive to produce, can be stored for extended periods, and are easily distributed for use in isolated locations, allowing for critical health data collection at the time and place it’s most needed. The team has developed a device known as a patterned dried blood spot card, which features channels and collection zones that precisely measure and dry specific volumes of blood for later analysis. Users simply need to draw blood with a finger prick

at home and mail the card to a laboratory, where the amount of DNA unique to white blood cells is measured to determine cell counts.

Additionally, the researchers have developed a paper analytical device to measure lactate, also known as lactic acid, in sweat. Lactate levels can signify oxygen deficiency and serve as a mortality predictor in trauma patients. For athletes or those working in physically demanding environments, lactate also measures muscle fatigue and fitness levels. This device uses bioreactive inks made from silk fibroin—a component of silk fibers—and enzymes that react with lactate to induce a color change. These inks are applied to small paper tabs that adhere to the skin

Cont’d on page 19

Microneedle
Image: Illustration of the microneedle patch (Photo courtesy of Karolinska Institutet)

Robotic Blood Drawing Device to Revolutionize Sample Collection

Blood drawing is performed billions of times each year worldwide, playing a critical role in diagnostic procedures. Despite its importance, clinical laboratories are dealing with significant staff shortages, which impact their ability to deliver timely test results and maintain satisfactory patient care. Now, an innovative robotic blood drawing device for the medical laboratory market could help ease staff workload and provide a more consistent patient experience.

Developed by Vitestro (Utrecht, The Netherlands; www.vitestro.com), this innovative blood-drawing device is designed to perform safe and accurate blood draws. It utilizes artificial intelligence (AI) for ultrasound-guided 3D reconstruction and ensures submillimeter precision in needle insertion. This high level of accuracy and consistency in blood collection is achieved through a combination of AI, advanced imaging technologies, and robotics. By automating blood draws, Vitestro’s device not only reduces the physical demand on staff but also enhances the satisfaction of both patients and healthcare providers. The introduction of this device marks a major innovation in blood collection, addressing the acute shortage of healthcare personnel and significantly improving the efficiency of clinical laboratories.

This innovation in phlebotomy offers a complementary approach to traditional manual blood sample collection. In the near future, patients can opt for autonomous blood draws using the device under the supervision of a trained healthcare professional. Vitestro has initiated the A.D.O.P.T. Trial to evaluate its autonomous blood drawing device on a large scale, planning to involve over 10,000 patients. This two-year study aims to further develop the device’s capabilities and obtain the required performance and safety data for regulatory approvals. Following the trial, Vitestro anticipates obtaining CE marking to enable autono mous venipuncture by the end of 2024. Several units of the device have already been pre-ordered and are expected to be installed in numerous European hospitals by the end of this year, signifying a significant step forward in automating the blood drawing process and enhancing patient care in clinical settings.

“Our technology represents a major step forward in healthcare in novation, benefitting both the institution and the patient,” said Brian Joseph, commercial director and co-founder at Vitestro. “We are actively expanding operations to grow in other important international markets, particularly within the United States.”

Image: Vitestro’s device combines AI-based, ultrasound-guided imaging with robotic needle insertion, ensuring accurate and secure blood collection.

Novel Shelf-Stable, Easy-to-Use Tests Bring Lab-Level Precision at POC

Cont’d from page 18

with a common transparent wound dressing film. The tabs change color from yellow to dark red depending on lactate concentration in the sweat, with color changes captured and analyzed using a smartphone camera, achieving accuracy comparable to sophisticated lab equipment.

“People in remote and low-income regions tend to have reduced access to healthcare, which makes it all the more important to come up with cheaper and easier ways for them to monitor indicators of health,” said Charlie Mace, associate professor of chemistry. “This technology is likely to have additional applications in infectious disease such as detecting levels of virus and parasites in the blood and more generally in detecting markers of health and wellness.”

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Automated Sepsis Test System Enables Rapid Diagnosis of Severe Bloodstream Infections

Sepsis affects up to 50 million people globally each year, with bacteraemia, formerly known as blood poisoning, being a major cause. In the United States alone, approximately two million individuals are affected by sepsis annually, resulting in around 250,000 deaths. Similar statistics are reported in the European Union. Sepsis is characterized by life-threatening organ failure due to a dysfunctional systemic immune response. Rapid and accurate diagnostic methods are essential for timely and effective treatment, which is critical for patient survival. Now, a fully automated system for rapid antimicrobial susceptibility testing (AST) significantly reduces the time required to obtain clinically actionable results, thereby speeding up the administration of optimal treatments from days to just hours.

The ASTar System from Q-linea AB (Uppsala, Sweden; www.qlinea.com) revolutionizes the treatment of sepsis by enabling a rapid therapeutic response directly from a positive blood culture in about six hours. This system equips physicians with the necessary tools to enhance patient outcomes and reduce mortality rates.

TTHROMBELASTOGRAPHY ANALYZER WONDFO

The TLT-101 thrombelastography analyzer is used to monitor and analyze the coagulation state of blood samples. It automatically records dynamic changes of venous whole blood with formation, retraction, and/ or lysis of blood clots.

The fully automated ASTar instrument ensures robust and consistent preparation of inoculums for AST, utilizing high-speed time-lapse microscopy to observe bacterial growth in broth, which helps determine the minimum inhibitory concentration (MIC). The ASTar system can be integrated with any rapid identification (ID) technology, enhancing laboratory capabilities and fulfilling the clinical demand for quicker diagnostic results.

The system includes an ASTar Consumable kit, which comprises two disposable components: a sample preparation Cartridge and an AST Disc. The Cartridge serves as a mini-lab, equipped with all necessary reagents and disposable items for sample preparation, concentration measurement, dilution, and growth medium adaptation. The AST Disc, used for AST and concentration determination, features over 330 culturing chambers pre-filled with antimicrobials at various concentrations, along with chambers for growth controls and bacterial concentration assessment for inoculum preparation. The ASTar system also combines high throughput with a user-friendly interface and simple load-and-go operation. Q-linea AB

Image: The ASTar System has received US FDA 510(k) clearance (Photo courtesy of Q-linea AB)

has recently received 510(k) market clearance from the U.S. Food and Drug Administration (FDA) for the ASTar System, which allows for its use in hospitals and laboratories across the United States.

“The approval is a significant step for Q-linea in the infectious disease diagnostics field in the U.S.,” said Stuart Gander, CEO of Q-linea. “Feedback from hospitals that have had early access to ASTar has been very positive, and we are excited to now be able to bring the system to labs across the U.S., which will make a real difference for patients with severe blood stream infections. We are pleased with the panel of drug-bug combinations which has been approved.”

New Tool to Revolutionize Sample Collection for Diagnostic Tests

he COVID pandemic has dramatically reshaped the perception of diagnostics. Post the pandemic, a groundbreaking device that combines sample collection and processing into a single, easy-to-use disposable unit could revolutionize the way samples are collected for diagnostic tests.

ReadyGo Diagnostics’ (Bath, UK; www. readygotest.com) Sampler device incorporates both the swab and collection buffers into one

device, making it exceptionally user-friendly. It is the world’s first universal tool of its kind that ensures convenience, reliability, and reproducibility right from the initial step of a diagnostic test. The patented technology behind the ReadyGo Sampler uses specially engineered materials that not only allow the device to collect the exact amount of sample required instantly but also rapidly break open viruses and bacteria, making them readily detectable in specific tests. The ReadyGo

Sampler device is intended to be a more user-oriented alternative to conventional swabbased sample collection methods by combining sample collection and processing into one disposable product.

This device is versatile, and compatible with various types of assays and uses, facilitating a swift and simple collection process that takes as little as five seconds. The Sampler is designed to cater to both consumer and profes-

Cont’d on page 21

IImage-Based AI Shows Promise for Parasite Detection in

Digitized Stool Samples

nfections from soil-transmitted helminths (STHs), commonly known as intestinal parasitic worms, are among the most widespread neglected tropical diseases and impose a significant health burden in low- and middle-income countries, particularly among schoolaged children. These infections often lead to chronic health issues that can cause disability, social stigma, and for their substantial economic impacts on communities. STHs are notorious role in nutrient loss, which can contribute to neurocognitive impairments, stunted growth and development, and persistent fatigue in affected children. Additionally, these parasites are a major cause of morbidity and complications during pregnancy. The standard diagnostic method for STHs involves manual microscopy, which requires up to 10 minutes per slide and is hindered by a lack of skilled professionals and access to necessary equipment and lab infrastructure in highly affected regions. There is a pressing need for improved diagnostic techniques, particularly for detecting infections of mild intensity, to effectively manage and aim for the elimination of STHs as a public health concern. Now, an artificial intelligence (AI) microscopy system has been shown to accurately identify intestinal worm infections, especially light-in tensity infections that could be overlooked when using manual microscopy.

The new study by a multi-institutional team of specialists from the Karolinska Institute (Stockholm, Sweden; of Helsinki (Helsinki, Finland; www.helsinki.fi ical trial of the system to detect worm infections in a remote setting with whole-slide images. The study was carried out in rural areas of Kwale County, Kenya, where there is a high prevalence of STHs among children. During the study, 1,335 school-aged children were screened using the deep learning-based system for parasitic worm egg detection, with results compared against those obtained through expert manual microscopy.

The analysis of digitally scanned stool samples using the deep learning system demonstrated high diagnostic accuracy in identifying three com mon types of parasitic worms: Ascaris lumbricoides Trichuris trichiura (whipworm), and hookworm ( or Necator americanus). The AI was able to detect between 76% and 92% of the infections identified by trained lab technicians, depending on the type of worm. Notably, the AI system identified a significant number of light-in tensity infections that were missed in manual microscopy evaluations. In fact, in 79 samples (10% of the total), which were initially determined to be negative by manual microscopy, the AI system detected the presence of parasitic worm eggs. Moreover, the AI system provides a digital record of each sample that can be preserved for further analysis, offering a significant advantage over human samples, which typically dry out within hours and become more challenging for further analysis. The study’s findings were published in the journal PLOS Neglected Tropical Diseases.

“We have shown that we can use our testing in a resource-limited setting and get high accuracy. Our method was especially efficient in light-intensity infections,” said Principal Investigator Professor Johan

Lundin, MD, PhD, from the Karolinska Institutet. “With AI, once our sample is digitised, it takes just a few second and looks at the entire

Sampling simplified.

New Tool to Revolutionize Sample Collection for Diagnostic Tests

Cont’d from page 20

sional testing markets and can accommodate various sample types such as saliva, buccal, blood, and urine. The patented Sampler device works with molecular tests like PCR and isothermal chemistries such as LAMP and RPA. Additionally, it is suitable for use in front of next-generation sequencing (NGS) protocols, including targeted sequencing and whole genome amplification (WGA). The technology allows for easy adaptation to incorporate other test chemistries, broadening its application to include simplified methods for biochemistry testing of physiological markers related to health and disease.

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Image: AI played critical role in intestinal worm infection screening among children in Kenya (Photo courtesy of University of Helsinki)

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AI Advancements Enable Leap into 3D Pathology

Human tissue is complex, intricate, and naturally three-dimensional.

However, the thin two-dimensional tissue slices commonly used by pathologists to diagnose diseases provide only a limited view of the tissue’s full complexity. As a result, there is a growing trend in pathology towards the examination of tissue in its three-dimensional form. Unfortunately, 3D pathology datasets can contain vastly more data than their 2D counterparts, rendering manual analysis impractical. Now, researchers have developed new, deep-learning models capable of utilizing 3D pathology datasets to predict clinical outcomes.

Tripath, developed by researchers from Mass General Brigham (Somerville, MA, USA; www.massgeneralbrigham.org) and their collaborators, aims to bridge the computational challenges of processing 3D tissue and predicting outcomes based on 3D morphological fea-

tures. In their study, the team utilized two 3D high-resolution imaging techniques to capture images of curated prostate cancer specimens. These models were trained to assess the risk of prostate cancer recurrence using volumetric human tissue biopsies.

Tripath has demonstrated superior performance compared to traditional pathologists and has outperformed existing deep learning models that rely on 2D morphology and thin tissue slices, by comprehensively capturing 3D morphologies from the entire tissue volume. While further validation in larger datasets is necessary before this innovative approach can advance to clinical application, the research team remains optimistic about its potential to enhance clinical decision-making.

“Our approach underscores the importance of comprehensively analyzing the whole volume of a tissue sample for accurate patient risk prediction, which is the hallmark of the

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Image: Tripath (far right) outperforms current clinical baseline (far left) and 2D deep learning baselines (middle) in cancer recurrence risk prediction (Photo courtesy of Mass General Brigham)

models we developed and only possible with the 3D pathology paradigm,” said lead author Andrew H. Song, PhD, of the Division of Computational Pathology in the Department of Pathology at Mass General Brigham.

New Tool Enables Better Classification of Inherited Disease-Causing Variants

Whole genome and exome sequencing are increasingly available for clinical research, aiding in the detection of inherited genetic variants that may cause various diseases. The American College of Medical Genetics-Association for Molecular Pathology (ACMG-AMP) provides regularly updated guidelines to help clinicians assess whether germline variants are likely related to a patient’s disease. However, automated tools often struggle to stay current with these updates. A new tool has now been developed that allows researchers to annotate variant data from large-scale studies with clinically relevant classifications for risks of childhood cancer and other diseases, aligning older applications with the latest guidelines. This tool is freely available to the research community. Developed by a team including scientists

from Children’s Hospital of Philadelphia (CHOP, Philadelphia, PA, USA; www.chop.edu), the tool, named Automated Germline Variant Pathogenicity (AutoGVP), incorporates germline variant pathogenicity annotations from the ClinVar database and variant classifications from a modified version of InterVar. AutoGVP provides pathogenicity classifications that adhere to the evolving ACMG-AMP guidelines by integrating information from both ClinVar and InterVar. It also addresses the limitations of the InterVar tool, particularly its tendency to overestimate the pathogenicity of loss-of-function variants that reduce the activity of a specific gene.

The utility of AutoGVP was highlighted in a study conducted by the research team, which analyzed germline DNA sequencing from 786 neuroblastoma patients and found 116 pathogenic or likely pathogenic variants. The study

revealed that these patients had a lower survival probability and identified BARD1 as a significant predisposition gene for neuroblastoma, featuring both common and rare pathogenic or likely pathogenic germline variations. AutoGVP was created to aid the large-scale annotation of germline variants and assign pathogenicity automatically. The team is currently applying AutoGVP to genetic data from pediatric brain tumor patients and larger neuroblastoma cohorts.

“With AutoGVP, we can streamline variant classification and swiftly incorporate new information as more and more biobanks release large sequencing data,” said Jung Kim, PhD, a staff scientist at the Division of Cancer Epidemiology and Genetics at the NCI.

“Furthermore, AutoGVP reduces hands-on curating of variants and allows for reproducibility of the variant curation.”

NNovel Technique Detects Biomarkers for Kidney Diseases with Nephritic Syndrome

ephrotic syndrome is associated with several kidney diseases such as minimal change disease (MCD), primary focal segmental glomerulosclerosis (FSGS), and membranous nephropathy (MN), and is characterized by high levels of protein in the urine. This condition primarily stems from damage to podocytes, the cells that filter blood in the kidneys, which results in protein leakage into the urine. Often, children diagnosed with MCD or FSGS are categorized under idiopathic nephrotic syndrome (INS), indicating an unknown cause. This is typically because children with elevated urinary protein levels seldom undergo kidney biopsies, which are the standard method for determining the underlying cause. Traditionally, the diagnosis of these conditions has been complicated due to their similar histological features and a general reluctance to perform invasive kidney biopsies, especially in children. Although anti-nephrin autoantibodies have been detected in some patients with MCD and FSGS, their exact role in the progression of these diseases remains unclear. A groundbreaking study recently presented at the 61st ERA Congress has made a significant breakthrough in diagnosing and monitoring kidney

cellular structures, suggesting that antibodies targeting nephrin play a role in podocyte dysfunction and the onset of nephrotic syndrome. Remarkably, this model required only a single immunization to trigger rapid disease onset, even with low concentrations of antibodies, unlike other models that need multiple immunizations.

“The identification of anti-nephrin autoantibodies as a reliable biomarker, coupled with our hybrid immunoprecipitation technique, enhances our diagnostic capabilities and opens new avenues for closely monitoring disease progression in kidney disorders with nephrotic syndrome,” said Dr. Nicola M. Tomas, co-lead author of the study.

“By providing insights into underlying

immunosorbent assay (ELISA) to accurately detect anti-nephrin autoantibodies. The results showed that these autoantibodies were present in 69% of adults with MCD and 90% of children with INS who had not received immunosuppressive treatments. The levels of these antibodies also correlated with the activity of the disease, indicating their potential as a biomarker for monitoring disease progression. These antibodies were seldom found in other diseases being studied.

In further experiments, researchers introduced laboratory-synthesized nephrin protein to mice, simulating conditions similar to MCD. This immunization led to phosphorylation of nephrin and significant changes in

Image: Researchers have detected novel biomarkers for kidney diseases using a new technique (Photo courtesy of 123RF)

mechanisms, these findings lay the groundwork for personalized interventions and pave the way for a new era of precision medicine for these complex conditions,” added Professor Tobias B. Huber, lead author of the study.

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AI Tool Predicts Cancer Patients’ Response to Immunotherapy

Immune checkpoint inhibitors are a form of immunotherapy drug that enables immune cells to target and destroy cancer cells. At present, the Food and Drug Administration has approved two predictive biomarkers for identifying patients who might benefit from immune checkpoint inhibitors. The first biomarker is tumor mutational burden, which measures the number of mutations in the DNA of cancer cells. The second biomarker is PD-L1, a protein found on tumor cells that inhibits the immune response and is targeted by some immune checkpoint inhibitors. However, these biomarkers are not always reliable in predicting a patient’s response to immune checkpoint inhibitors. Recent machine-learning models utilizing molecular sequencing data have demonstrated

potential in predicting responses, but this data is costly and not routinely collected. Researchers have now created an artificial intelligence (AI) tool that uses standard clinical data, such as results from a basic blood test, to predict if a patient’s cancer will respond to immune checkpoint inhibitors.

The machine-learning model, named Logistic Regression-Based ImmunotherapyResponse Score (LORIS; loris.ccr.cancer.gov), was developed by scientists at the National Cancer Institute (Bethesda, MD, USA; www. ccr.cancer.gov). It aims to assist doctors in determining the efficacy of immunotherapy drugs for a patient’s cancer treatment. The AI model bases its predictions on five clinical features routinely collected from patients: age, cancer type, history of systemic therapy, blood

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albumin level, and blood neutrophil-to-lymphocyte ratio, an indicator of inflammation. The model also considers tumor mutational burden, evaluated through sequencing panels. This model was built and validated using data from multiple independent datasets comprising 2,881 patients treated with immune checkpoint inhibitors across 18 types of solid tumors. The model accurately predicted both a patient’s likelihood of responding to an immune checkpoint inhibitor and their overall survival time, including the period before disease recurrence. Remarkably, the model also identified patients with low tumor mutational burden who could still benefit from immunotherapy. The findings of the study were published in Nature Cancer on June 3, 2024. The researchers emphasized the need for larger prospective studies to further validate the AI model in clinical settings and have made it publicly accessible.

Image: The AI tool predicts whether someone’s cancer will respond to immune checkpoint inhibitors (Photo courtesy of National Cancer Institute)

IFCC WorldLab Dubai 2024: A Resounding Success!

Dear Colleagues, Dear Friends,

On behalf of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC), and as the Congress President, I would like to express my heartfelt gratitude to all those who contributed to the 26th International Congress of Clinical Chemistry and Laboratory Medicine (ICCCLM) - IFCC WorldLab Congress, which was successfully held at the Dubai World Trade Centre (DWTC) from May 26 to May 30, 2024. The WorldLab Congress Dubai was organized jointly with the 17th Congress of the Arab Federation of Clinical Biology (AFCB), the 10th Annual Meeting of the Saudi Society for Clinical Chemistry (SSCC), and the 8th International and United Arab Emirates (UAE) Genetic Disorders Conference in partnership with MZ Events.

The WorldLab Congress brought together scientists, researchers, clinicians, and experts from the in vitro diagnostics industry for a rewarding five-day experience of scientific exploration and education.

I would like to share some brief statistical data about the Congress:

2,045 delegates from 107 nations, 1,700 visitors, 255 faculty members, 600 exhibitors’ staff, and 39 companies, occupying 1,100 sqm of exhibition area, attended the Congress.

Preceding the main Congress, the 3rd IFCC FORUM for Young Scientists was organized. The Forum was a resounding success, featuring many young scientists (YS) as speakers and moderators. It was an excellent opportunity for networking and sharing experiences among YS from all over the world. In the morning, the Forum participants received a visit from Sheikh Theyab Bin Khalifa Bin Shakhbout Al Nahyan, who addressed the participants with a speech highlighting the UAE’s programs in support of Young Scientists. The YS also attended the main Congress and participated in a competition involving a poster tour judged by both junior and senior scientists. The best three posters were awarded an IFCC t-shirt.

On the occasion of the IFCC WorldLab Congress, the IFCC Council meeting took place on Sunday, May 26th, from 1:00 pm

to 4:00 pm. After the presentation of the Executive Board reports and IFCC Divisions’ Reports, the last part of the Council meeting was allocated for a plenary discussion with IFCC member societies and corporate members on the topics entitled “Current and Future Advances and Challenges in Laboratory Medicine.”

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Tomris Ozben, EuSpLM, Ph D; Full
of Clinical Biochemistry; IFCC President; Congress President, IFCC WorldLab Dubai 2024
Image: IFCC and Congress President Prof. Tomris Ozben flanked by UAE dignitaries and IFCC leaders at the inaugural plenum.

With excitement and honor, the IFCC, in partnership with Abbott and six other prestigious partner organizations, celebrates 12 UNIVANTS of Healthcare Excellence award winning teams. These 2024 winning teams are recognized for “UNIFYING” across disciplines to enable

2024 Univants of Healthcare Awards: The 12 Global Winners Announced

the development and implementation of “AVANT-GARDE” processes to enable measurably better health outcomes.

These innovative best practices tackled varying disease states, including hypercholesterolemia, sexually transmitted and blood-borne infections, liver disease, traumatic brain injury, diabetes, and more. Blindly reviewed through rigorous and comprehensive scoring, these teams were selected for their impact on patients, payors, clinicians and entire health systems/administration. Outcomes include

UNIVANTS OF HEALTHCARE EXCELLENCE TOP ELITE WINNERS

GetCheckedOnline: Better access to testing for sexually-transmitted and blood-borne infections

British Columbia Centre for Disease Control

Early detection of metabolic-dysfunction associated steatotic liver disease using FIB-4

Premier Integrated Labs Sdn Bhd

Improved management of patients with high LDL-C through electronic health recorddirected algorithms for guideline-concordant high-intensity statin prescribing

Kaiser Permanente Southern California

UNIVANTS OF HEALTHCARE EXCELLENCE RECOGNITION OF DISTINCTION

Improving equity in maternal and newborn outcomes by eliminating disparities in maternal drug screening

Washington University School of Medicine, Barnes-Jewish Hospital, and St. Louis Children’s Hospital

Improving access to health services in vulnerable communities affected by war Esculab

Improved patient outcomes facilitated by c-peptide testing, enabling reclassification and therapeutic changes for patients with diabetes University Hospital of Wales

Reducing unnecessary CT scans in the emergency department with new mild head injury assessment pathway Klinikum Lüneburg

The Kansas Two-Step: Simplifying the diagnosis of clostridioides difficile at an academic medical center

The University of Kansas Health System

No time to lose with lives on the line - Maximizing efficiency in the lab to save more lives through organ donation

Southwest Transplant Alliance

The Women and Heart Program - Empowering women’s health through early identification and prevention of coronary risk Institute for Cardiovascular Prevention and Rehabilitation

Reducing unnecessary admissions associated with pediatric mononucleosis via implementation of EBV IgM testing in the emergency department

Emergency Clinical County Hospital Targu Mures

Establishment of a monomer prolactin detection method and specific reference interval to enhance the ability to identify macroprolactinemia

Huashan Hospital Fudan University

closing care gaps, enhancing health equity, improving women’s health, enabling access to care, improving safety, and more. With 3 top global winners, 3 teams of distinction, and 6 teams of achievement (see table below), these diverse and innovative initiatives span geographies, health systems, patients and disease states.

Yoke Lee Low Hareeff Muhammed

Viktoriia

Vahid Azimi

Jeannie Kelly

Lauren Nacke

Honcharenko

Anna Konyk

Olena Yanchinska

Arshiya Tabasum

Colin Dayan

Rowan Hellier

Leslie Charles Lai Chin Loy Mun Yee, Evonne Kong

Kristi

More details on these best practices and/or the award program itself can be found at www.UnivantsHCE.com. Also available are valuable links, tips and tricks, as well as access to an application portal for all healthcare teams who wish to apply for 2025 recognition through the UNIVANTS of Healthcare Excellence awards. Applications are accepted starting August 1 through until Nov 15, 2024.

Noor Riaz

Stephen Roper

Liudmyla Kostiuk

Iryna Mandzyuk

Carol Evans

Julia Johansson Evans

Felix Brüning-Wolter

Meike Schrader

Nicola Wolff

Matthew Loeb

Matt Humphrey

Sarah Mester

Selena Warden

Doug Butler

Sean Forquer

Andrea Snagić Goran Krstačić

Oana Roxana Oprea

Karoly Vecsei

Florina Floristeanu

Ming Guan Yao Hu Hongying Ye

Thomas Rodt

Jörg Cramer

Matt Shoemaker

Maggie Reavis

Reid Freeman

Cristina Solomon

Ante Miljak Sonja Frančula-Zaninović

Lucia Mezei Dobreanu Minodora

Zhaoyun Zhang Yao Zhao

With 3 top global winners, 3 teams of distinction, and 6 teams of achievement (see table below), these diverse and innovative initiatives span geographies, health systems, patients and disease states. To learn more about these best practices, please visit www. UnivantsHCE.com.

The UNIVANTS of Healthcare Excellence award program is proudly comprised of the following program partners: International Federation of Clinical Chemistry (IFCC), Association for Diagnostics and Laboratory Medicine (ADLM, formerly AACC), Modern Healthcare, National Association for Healthcare Quality (NAHQ), European Health Management Association (EHMA), Institute of Health Economics (IHE), Healthcare Information and Management Systems Society (HIMSS); each in partnership with Abbott.

Garth Graham
Mark Gilbert Susie van der Valk
Matthew Mefford
Michael Kanter
Ronald Scott
Reynolds Tracy Imley

WorldLab Congress Hosts 3rd IFCC Forum for Young

Scientists

Reported by Task Force Young Scientist members (Tara Rolić, Josep Miquel Bauçà, Kamil Taha Uçar and Marie Lenski)

The 3rd Young Scientist Forum provided attendees, speakers, moderators, and organizers with a fantastic opportunity to present their specific and professional work and connect with young colleagues from around the world facing similar challenges and sharing the same enthusiasm for their profession. Held at the Conrad Hotel in Dubai, UAE, just before the opening of the 26th International Congress of Clinical Chemistry and Laboratory Medicine, the forum saw over 200 registered young scientists.

Participants had a wonderful chance to exchange knowledge and experiences about their daily work and research by presenting their scientific pathways. The first session, coordinated by Marie Lenski (France) and Tamar Ramishvili (Georgia), focused on digital technology innovations in laboratory medicine. Jonatas Barbosa Garcez (Portugal) discussed the need for quality control for eGFR in clinical settings, while Tara Rolić (Croatia) presented on calculating reference intervals for thyroid hormones using an indirect approach. Mia Gruzin (Australia) introduced a novel tool for improving the quality of genetic pathology postanalytical reports, and Layla Dawood (UAE) talked about interpretable machine learning in dementia. During the coffee break, participants had the honor of being welcomed by Sheik Theyab Bin Khalifa Bin Shakhbout Al Nahyan, who wished them a prosperous future.

The second session, designed following young scientists' initiative to organize case series webinars, was coordinated by Udara Senarathne (Sri Lanka) and Claudia Imperiali (Spain). It featured case reports from Danda Vasconcelos Santos Milena (Brazil), Laura Valina (Spain), Hamudin Mohd Amirul (Malaysia), and Zeenath Thaneeda Mohamed Thowfeek (Sri

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IFCC FORUM For Young Scientists 3° Edition

United Arab Emirates, Dubai 26th May, 2024

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Join us in Chicago for a once in a lifetime meeting of the minds that will unite global laboratory medicine leaders for:

• Five plenaries, 65+ scientific sessions, and 170 roundtables

• 12 ADLM University courses offering practical skills for laboratorians

• 900+ exhibitors, 200+ product categories and live demos

• Networking opportunities to connect with industry peers and leaders

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Jingcai Wang MD, PhD, NRCC, SH(ASCP), MLS

WorldLab Congress Hosts 3rd IFCC Forum for Young Scientists

page 27

Lanka): Creutzfeldt-Jakob Disease in Brazil, Clonal Isotype Switch: phenomenon after haematopoietic stem cell transplantation, Uncommon Detection of Monoclonal Proteins in Alpha 2 Region on Serum Protein Electrophoresis: A Case Series and Unlocking the Mystery of Hirata Syndrome: A Fascinating Journey Through Recurrent Hypoglycemia and the Intricacies of Insulin Autoimmune Syndrome (IAS). The session concluded with a discussion table where attendees had the unique opportunity to ask questions and comment on their own case reports.

The third and most interactive session was coordinated by Kamil Taha Uçar (Turkey) and Santiago Fares Taie (Argentina). This session was truly inspiring for both future and current leaders, thanks to the perspective into the laboratory of the future. Sean Campbell (USA) started the session by dividing attendees into groups to discuss leadership and mentorship challenges. Ashlin Rampul (South Africa) presented Mandela’s principles of leadership, highlighting aspects that young scientists can do to improve in their lives and positions. Atwi Maya (UAE) inspired attendees with her work on unlocking

cancer's secrets and the key role of stem cells. Josep Miquel Bauçà (Spain) delved into the psychology of leadership and management, discussing personality traits and their impact on an effective communication and time management. The session concluded with Sibtain Ahmed (Pakistan) discussing the pros and cons of POCT, followed by a fruitful discussion on user experiences.

Based on the impressions of the moderators, speakers, and attendees, the forum was a wonderful and truly successful event. Thanks to the remarkable support of the IFCC and notable figures such as Prof. Tomris Ozben, Prof. Khosrow Adeli, Dr. Maryam Matar, Dr. Eduardo Freggiaro, Dr. Alvaro Justiniano, and Prof. Rajiv Erasmus, the forum provided a fruitful scientific, professional, and personal networking experience. Young scientists from all over the world showcased their knowledge and pushed forward the boundaries of their field. As even the senior participants concluded, young scientists are not the future of laboratory medicine; they are today’s leaders. Until the next forum, keep up the excellent work and strive for the best.

IFCC WorldLab Dubai 2024: A Resounding Success!

The WorldLab Congress began with the Opening Ceremony on Sunday, 26th May 2024, at 5 pm. Following the welcome addresses of the Congress Organizing Committee members representing IFCC, the Arab Federation of Clinical Biology (AFCB), the Saudi Society for Clinical Chemistry (SSCC), and

United Arab Emirates Genetic Diseases Association (UAEGDA), the stimulating keynote lecture entitled “Pushing forward the frontier of cfDNA diagnostics” was presented by Prof. Dennis Lo from The Chinese University of Hong Kong.

The Scientific Program of the Congress had a multidisciplinary agenda, covering fundamental concepts, advanced diagnostics, and cutting-edge techniques in laboratory medicine. Esteemed international speakers and key opinion leaders addressed diverse topics, including healthcare, recent diagnostic technologies, scientific breakthroughs, and emerging challenges.

The congress served as a platform to showcase the latest technologies and innovations in laboratory medicine and explore their potential applications in healthcare.

Several IFCC Functional Units’ meetings were held during the Congress, bringing together the Chairs and Members to discuss their activities and projects.

IFCC Executive Board (EB) members met with the IFCC Corporate members (CMs) to provide direct and transparent communication between the IFCC EB and IFCC CMs.

The 2024 IFCC DISTINGUISHED AWARDS, selected by the IFCC Awards Committee, were announced at the Opening Ceremony and presented to the seven winners at the Awards Ceremony dinner, held on Monday, 27th May 2024, at the Dubai World Trade Center.

My heartfelt thanks to the in vitro diagnostics sector; their continuous support and contributions have made the success of this Congress possible. The In Vitro Diagnostic (IVD) Sector played a vital role in the Congress by organizing two essential activities: high-level Educational Workshops on important topics, featuring eminent speakers presenting the

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IFCC OFFICE

Via Carlo Farini 81, 20159 Milan, ITALY

Tel: (39) 02-6680-9912 • E-mail: ifcc@ifcc.org • Web: www.ifcc.org

Staff Members: Paola Bramati, Silvia Cardinale, Silvia Colli-Lanzi, Elisa Fossati, Sofia Giardina, Smeralda Skenderaj

in Diagnostic Testing

R

oche (Basel, Switzerland) and Hitachi High-Tech (Tokyo, Japan) have renewed their collaboration agreement, committing to a further 10 years of partnership. This extension brings together their long-standing expertise in diagnostics innovation, engineering, and manufacturing, and further strengthens their long-lasting relationship.

The collaboration between the two companies has led to significant advancements, setting new standards for in-vitro diagnostic solutions. They have transformed clinical laboratories with the debut of the world’s first multi-channel analyzer and have automated immunology processes. These pioneering developments have allowed healthcare facilities to improve service delivery and provide essential care to patients. Presently, Roche systems that are covered under this collaboration handle over 21 billion tests annually, a figure that is anticipated to rise following the renewal of their agreement. The extensive scale and scope of their operations enable the rapid distribution of new tests and technologies globally, enhancing efficiency, accuracy, and reliability through automation, which minimizes the need for manual labor.

In the upcoming months, Roche and Hitachi High-Tech are set to launch new products, including the cobas c 703 and cobas ISE neo analytical units as part of the cobas pro integrated solutions. These innovations aim to boost laboratory testing capabilities and provide precise, timely diagnoses to millions globally. Moreover, by year’s end, the introduction of the cobas Mass Spec solution will integrate fully automated mass spectrometry into everyday laboratory use, making this gold-standard technology more accessible for a variety of clinical uses worldwide. Such innovations are transforming the delivery of diagnostics, enhancing the sustainability and resilience of healthcare systems. The extended partnership underscores Roche and Hitachi High-Tech’s joint commitment to pushing the boundaries of technology, improving laboratory efficiencies, supporting medical

Cont’d from page 28

latest scientific advances in all disciplines relevant to laboratory medicine. The IVD Sector also organized an extensive exhibition, providing attendees with a prime opportunity to explore recent technological advancements, products, and services aimed at enhancing laboratory operations.

I would like to express my heartfelt gratitude to all the eminent speakers, chairs, IVD industry representatives, and all the participants attending the Congress from different countries around the world.

The exceptional hospitality of the United Arab Emirates Genetic Disorders Association (UAEGDA), and the support and high interest of UAE high health authorities, several Ministers, and Sheikhs, were highly appreciated by the congress organizers and attendees.

I would like to acknowledge and thank the Professional Congress Organizer (MZ Events) for their dedicated efforts in organizing the congress successfully.

On this occasion, I would like to invite you to the next EuroMedLab and WorldLab Congresses. I warmly invite you to join us at the 26th IFCC-EFLM EuroMedLab Congress, which will be hosted by the Royal Belgian Society of Laboratory Medicine from May 18th to May 22nd, 2025, in Belgium, Brussels, and I extend to you a warm invitation to attend the 27th WorldLab Congress, organized jointly with the Asia and Pacific Federation of Clinical Chemistry (APFCB) and the Association of Clinical Biochemists of India (ACBI) in New Delhi, India, from October 25 to October 29, 2026.

I wish many successful congresses to be held and hope to meet you all at other scientific and educational events.

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2024

JULY

MedLab Asia 2024. Jul 10-12; Bangkok, Thailand; medlabasia.com

9th Annual Academic Sessions & Lab Expo 2024 – College of Chemical Pathologists of Sri Lanka. Jul 12-13; Colombo, Sri Lanka; ccpsrilanka.com

34th MACB Conference 2024 – Malaysian Association of Clinical Biochemists. July 21-23; Kuala Lumpur, Malaysia; macb.org.my

2024 ADLM Annual Scientific Meeting & Clinical Lab Expo. Jul 28 - Aug 1; Chicago, IL, USA; meeting. myadlm.org

AUGUST

Chilean Congress of Clinical Chemistry and Laboratory Sciences. Aug 21-22; Santiago, Chile; schqc.cl

64th Annual Academic Assembly of the Japan Society of Clinical Chemistry (JSCC). Aug 30 - Sep 1; Utsunomiya, Japan; jscc-jp.gr.jp

SEPTEMBER

ASCP 2024 – Annual Meeting of the American Society for Clinical Pathology. Sep 4-6; Chicago, IL, USA; ascp. org

SSCC/SGKC Annual Assembly 2024 – Swiss Society of Clinical Chemistry. Sep 4-6; Zurich, Switzerland; sscc2024.ch

17th Baltic Congress of Laboratory Medicine. Sep 5-7; Vilnius, Lithuania; balm2024.lt

ECP 2024 – 35th Congress of the European Society of Pathology. Sep 7-11; Florence, Italy; esp-congress.org

EUROTOX 2024 – 58th Congress of the European Societies of Toxicology. Sep 8-11; Copenhagen, Denmark; eurotox2024.com

46th Mexican National Congress of Clinical Chemistry and ExpoQuím. Sep 9-14; Morelia, Mexico;

miconaquic.com

Thailand LAB International 2024. Sep 11-13; Bangkok, Thailand; thailandlab.com

23rd Serbian Congress of Medical Biochemistry and Laboratory Medicine. Sep 16-18; Belgrade, Serbia; dmbj.org.rs

NFKK 2024 – 39th Nordic Congress of Clinical Chemistry. Sep 17-20; Stockholm, Sweden; nfkk2024.se

ESVC 2024 – Annual Meeting for the European Society for Clinical Virology. Sep 17-21; Frankfurt, Germany; escv.eu

DKLM 2024 – Annual Congress of the German Society for Clinical Medicine and Laboratory Medicine (DGKL). Sep 25-27; Bremen, Germany; dgkl.de

LMCE-KSLM 2024- Laboratory Medicine Congress & Exhibition and 65th Annual Meeting of the Korean Society of Laboratory Medicine. Sep 25-27; Seoul, Korea; lmce-kslm.org

India Lab Expo & Analytica Anacon India. Sep 26-28; Hyderabad, India; analyticaindia.com

16th Bulgarian National Conference of Clinical Laboratory. Sep 27-29; Varna, Bulgaria; bscl.eu

OCTOBER

COLABIOCLI 2024 - 26th Latin American Congress of Clinical Biochemistry. Oct 3-6; Cartagena, Colombia; colabiocli.com

56th National Congress of the Italian Society of Clinical Biochemistry and Clinical Molecular Biology (SIBioC). Oct 8-10; Bologna, Italy; sibioc.it

JFBM 2024 – Journées Francophones de Biologie Médicale. Oct 9-11; Troyes, France; jfbm.fr

27th Congress of the Latin American Association of Clinical Pathology/Laboratory Medicine (ALAPAC). Oct 9-12; Lima, Peru; congresoalapac2024.com

11th Congress of Croatian Society of Medical Biochemistry and Laboratory Medicine. Oct 9-12; Vodice, Croatia; kongres2024.hdmblm.hr

33rd WASPaLM World Congress – World Association of Societies of Pathology and Laboratory Medicine. Oct 16-20; Antalya, Turkey; waspalm-association.org

CAP24 – Annual Meeting of the College of American Pathologists. Oct 19-22; Las Vegas, NV, USA; cap.org

ASHI 2024 – 50th Annual Meeting of the American Society for Histocompatibility and Immunogenetics. Oct 21-24; Anaheim, CA, USA; ashi-hla.org

22nd Meeting of the European Association for Hematopathology. Sep 21-26; Dubrovnik, Croatia; society-for-hematopathology.org

MedLab Africa 2024. Oct 22-24; Johannesburg, South Africa; africahealthexhibition.com

ICBMB 2024 - 19th Iranian National Congress of Biochemistry. Oct 23-25; Tehran, Iran; icbmb.ir

BCLF 2024 – 31st Meeting of the Balkan Clinical Laboratory Federation & 35th National Congress of the Turkish Biochemical Society. Oct 28 - Nov 1; Antalya, Turkey; turkbiyokimyadernegi.org.tr

APFCB Congress 2024 – Asia Pacific Federation for Clinical Biochemistry and Laboratory Medicine. Oct 31 - Nov 3; Sydney, Australia; apfcbcongress2024.org

NOVEMBER

ALACI 2024 – 14th Latin American and Caribbean Immunology Congress. Nov 4-8; Buenos Aires, Argentina; alaci.org

ASHG 2024 – Annual Meeting of the American Society of Human Genetics. Nov 5-9; Denver, CO, USA; ashg.org

JIB 2024 – Journées de l’innovation en biologie. Nov 7-8; Paris, France; jib-innovation.com

72nd Annual Scientific Meeting of the American Society of Cytopathology (ASC). Nov 7-10; Orlando, FL, USA; cytopathology.org

46 Annual ACBI Conference 2024 – Association of Clinical Biochemists in Ireland. Nov 8-9; Dublin, Ireland; acbi.ie

22nd Greek National Congress of Clinical Chemistry. Nov 8-10; Athens, Greece; eekx-kb.gr

MEDICA 2024. Nov 11-14; Dusseldorf, Germany; medica-tradefair.com

45th Annual Meeting of the American College of Toxicology (ACT). Nov 17-20; Austin, TX, USA; actox.org

Analytica China 2024. Nov 18-20; Shanghai, China; analyticachina.com.cn

AMP 2024 – Annual Meeting & Expo of the Association for Molecular Pathology. Nov 21-23; Vancouver, BC, Canada; amp.org

LABCLIN 2024 – 18th National Congress the Spanish Societies for Clinical Laboratory (AEBM-ML, AEFA & SEQCML). Nov 20-22; Bilbao, Spain; labclin2024.es

Chem Con 2024 – 15th Annual Congress of the Pakistan Society of Chemical Pathologists (PSCP). Nov 2223; Peshawar, Pakistan; pscp.org.pk

ADLM Middle East 2024. Nov 23-24; Dubai, UAE; adlmme.org

ASI 2024 – 52nd Annual Scientific Meeting of the Australian and New Zealand Society for Immunology. Nov 25-29; Sydney, Australia; immunology.org.au DECEMBER

ACBICON 2024 – 50th Annual Conference of the Association of Clinical Biochemists of India. Dec 4-7; Chandigarh, India; acbicon2024.com

66th ASH Annual Meeting and Exposition – American Society of Hematology. Dec 7-10; San Diego, CA, USA; hematology.org

FAIS 2024 – 12th Congress of the Federation of African Immunological Society. Dec 9-13; Cotonou, Benin; faisafrica.com

AMBICON 2024 – Association of Medical Biochemists of India. Dec 19-21; Ahmedabad, India; ambi.co.in

2025

JANUARY

SLAS 2025 – International Conference & Exhibition of the Society of Laboratory Automation and Screening. Jan 25-29; San Diego, CA, USA; slas.org FEBRUARY

Medlab Middle East 2025. Feb 3-6; Dubai, UAE; medlabme.com

Labquality Days 2025 – International Congress on Quality in Laboratory Medicine. Feb 6-7; Helsinki, Finland; labqualitydays.fi

MARCH

34th Annual Meeting of the Society of Virology (GfV). Mar 4-7; Hamburg, Germany; virology-meeting.de China Lab Expo 2025. Mar 5-7; Guangzhou, China; chinalabexpo.com

USCAP 113th Annual Meeting – United States and Canadian Academy of Pathology. Mar 22-27; Boston, MA, USA; uscap.org

APRIL

ESCMID Global 2025. Apr 11-15; Vienna, Austria; escmid.org

Korea Lab 2024. Apr 22-25; Seoul, Korea; korealab.org ECV 2025 – 9th European Congress of Virology. Apr 27-30; Dubrovnik, Croatia; eusv.eu

AACR Annual Meeting 2025 – American Association for Cancer Research. Apr 25-30; Chicago, IL, USA; aacr.org

MAY

Immunology 2025– Annual Meeting of the American Association of Immunologists (AAI). May 3-7; Honolu lu, HI, USA; immunology2025.aai.org

ISLH 2025 Congress – International Society for Laboratory Hematology. May 7-9, Halifax, NS, Canada; islh.org

26th IFCC-EFLM EuroMedLab Congress of Clinical Chemistry and Laboratory Medicine. May 18-22; Brussels, Belgium; euromedlab2025brussels.org

Hospitalar 2025. May 20-23; Sao Paulo, Brazil; hospitalar.com

SLAS Europe 2025 Conference and Exhibition - Society of Laboratory Automation and Screening. May 22-24; Hamburg, Germany; slas.org

ESHG 2025 - European Human Genetics Conference. May 24-27; Milan, Italy; eshg.org

JUNE

ISBT Milan 2025 – 35th Regional Congress of the International Society of Blood Transfusion. Jun 1-4; Milan, Italy; isbtweb.org

FIME 2024 – Florida International Medical Expo. Jun 11-13; Miami, FL, USA; fimeshow.com

108th Annual Meeting of the German Society for Pathology. Jun 12-14; Leipzig, Germany; pathologie-dgp.de

EHA 2025 Congress – European Hematology Associa

tion. Jun 12-15; Milan, Italy; ehaweb.org

ASM Microbe 2025 – American Society for Microbiology. Jun 19-23; Los Angeles, CA, USA; asm.org

ISTH 2025 Congress – International Society on Thrombosis and Haemostasis. Jun 21-25, Washington, DC, USA; isth2025.org

FOCIS 2025 – Annual Meeting of the Federation of Clinical Immunology Societies. Jun 24-27; Boston, MA, USA; focisnet.org

JULY

FEBS 2025 – 49th Congress of the Federation of European Biochemical Societies. Istanbul, Turkey; Jul 5-9; febs.org

FEMS 2025 – 11th Congress of European Microbiologists. Jul 14-17; Milan, Italy; fems-microbiology.org

ASV 2025 – 44th Annual Meeting of the American Society of Virology. Jul 14-18; Montreal, Canada; asv.org

2025 ADLM Annual Scientific Meeting & Clinical Lab Expo. Jul 27-31; Chicago, IL, USA; meeting.myadlm.org

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