Hypothyroidism impacts about 10% of the U.S. population, making the Thyroid Stimulating Hormone (TSH) test the most frequently conducted immunoassay in the United States. Traditional testing often involves significant time commitments for patients,
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Blood-Based Diagnosis Detects Prenatal Exposure to Birth Disorders
Researchers are employing sophisticated technology and artificial intelligence (AI) to improve the diagnosis of rare diseases and prenatal exposure-related birth abnormalities, as detailed in two studies featured in the American Journal of Human Genetics and
Breakthrough Platelet Test Detects
Genetics in Medicine. The technology, known as EpiSign, utilizes AI to analyze the epigenome — each individual’s unique chemical code that overlays their DNA and regulates gene activity. Currently, EpiSign assists in diagnosing over 100 genetic conditions that have
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AI Improves Lung Cancer Diagnosis
LBreakthrough Platelet Test Detects Previously Unmeasured Cardiovascular Risks
Previously Unmeasured Cardiovascular Risks
bioinformatics, researchers have developed a breakthrough metric called Platelet Reactivity ExpresSion Score (PRESS) that effectively identifies those at risk of heart attack and would benefit from anti-platelet therapy.
Blood Test Predicts Alzheimer’s With Over 90% Accuracy
Alzheimer’s disease impacts one in five women and one in ten men over their lifetimes, yet diagnostic tools are still often cumbersome and not widely accessible in primary care settings. Although specialized memory clinics frequently use advanced diagnostic methods like PET scans and cerebrospi-
Magnetic Microneedle Array Robots to Revolutionize Tissue Slicing and Cultivation
The cultivation of patient-derived tissues in vitro is essential for accurate diagnosis, targeted treatments, and advancements in tissue engineering. However, traditional methods of tissue slicing and cultivation often do not meet the clinical needs. Addressing this
gap, a groundbreaking method has been developed that incorporates a controllable histotomy technique using hierarchical magnetic microneedle array robots. This innovation not only enhances tissue analysis capabilities but also paves the way for
ung cancer ranks among the most prevalent and fatal cancers worldwide. Current treatment strategies for lung cancer patients rely on pathological examinations, which can reveal genetic mutations specific to the patient’s cancer, facilitating personalized treatment approaches. Over the last few years, pathology has evolved dramatically due to digital advancements, making
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Earlier Detection of Pancreatic Cancer
Pancreatic ductal adenocarcinoma (PDAC), the most prevalent type of pancreatic cancer, is highly lethal but can potentially be cured with surgery and modern treatments. There is a pressing need for a simple, quick, and accessible blood test to diagnose pancreatic cancer early in at-risk individuals. Now, a new pancreatic cancer detection test offers significantly improved ac-
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PBreakthrough Platelet Test Detects Previously Unmeasured
Cardiovascular Risks
latelets, which are cell fragments circulating in the blood, play a critical role in clot formation to stop bleeding. However, in some individuals, platelets can become “hyperreactive,” leading to excessive clotting and causing heart attacks, strokes, and peripheral artery disease, affecting millions worldwide. Until now, assessing platelet reactivity in patients has been challenging due to inconsistencies in the conventional test, platelet aggregometry, which often shows varied results across different laboratories. To overcome this issue, researchers have now accurately identified patients with hyperreactive platelets and conducted a study revealing significant genetic variations among those with hyperreactive platelets compared to others. Using bioinformatics, they developed a new metric called the Platelet Reactivity ExpresSion Score (PRESS), which effectively identifies those at risk of heart attacks and spots those who might not yet know their risk.
Researchers at NYU Grossman School of Medicine (New York, NY, USA; www.med.nyu.edu) designed PRESS by switching to a low-dose epinephrine aggregometry technique, which is more indicative of hyperreactivity than previous high-dose tests. This method determined hyperreactive platelets based on their reaction to a minimal stimulus. To move beyond the confines of specialized laboratory techniques, the team developed PRESS as a standardizable, genetic-based score to predict cardiovascular risk. This tool was designed to be broadly applicable, avoiding the variability of direct platelet testing.
The researchers validated the clinical relevance of PRESS in a study tracking major adverse cardiovascular events in patients undergoing procedures to clear blocked arteries. Upon comparing PRESS to traditional aggregometry results and examining its diagnostic ability in various patient populations, they found that higher PRESS scores correlated with increased cardiovascular events. The findings, published online on August 20 in Nature Communications, found that those identified as having hyperreactive platelets faced a significantly higher risk of serious cardiovascular events shortly after surgery, providing a new tool for early identification and management of patients at risk due to platelet hyperreactivity.
“Our results demonstrate that our new platelet-centric scoring system can, for the first time and across populations, circumvent aggregometry to reliably predict platelet hyperreactivity and the related risk of cardiovascular events,” said corresponding study author Jeffrey Berger, MD, director of the Center for the Prevention of Cardiovascular Disease at NYU Grossman School of Medicine.
“In current practice, anti-platelet therapy is not routinely recommended for the prevention of a first heart attack or stroke, but a plateletbased test would help to identify patients at highest risk, and those who would benefit most from anti-platelet therapy to prevent a cardiovascular event,” added study author Tessa Barrett, PhD, assistant professor in the departments of Medicine and Pathology at NYU Langone. “Our score has the potential to further personalize cardiovascular disease risk prevention.”
Image: The new platelet-centric scoring system predicts platelet hyperreactivity and related risk of cardiovascular events (Photo courtesy of Shutterstock)
Magnetic Microneedle Array Robots to Revolutionize Tissue Slicing and Cultivation
personalized medicine and the development of more effective therapies. As this technology evolves, it is anticipated to significantly impact biomedical research and clinical practices.
A team from Nanjing Drum Tower Hospital (Nanjing, China; www.njglyy.com) has pioneered this innovative tissue slicing and cultivation method that promises to transform how primary tissues are managed in medical settings. Described in a research article published in Engineering, the method employs a three-dimensional printed slicing device with a mortise-tenon structure and a pagoda-shaped microneedle array scaffold loaded with magnetic particles. The multilayered structure of the microneedles ensures stable fixation of tissue samples during slicing, preventing slippage. Additionally, the encapsulated magnetic microneedle fragments convert tissue sections into biohybrid microrobots that can be magnetically manipulated for separation, transport, and dynamic culture.
This method was tested with primary pan-
creatic cancer tissues, which were segmented into small sections and cultured in multilayered microfluidic chips for comprehensive drug screening. The outcomes are promising for clinical application, marking a substantial advancement in the field of precision medicine. The research article also outlines potential enhancements, such as automating the tissue sectioning process and increasing the throughput of the microtomy device. Going forward, the researchers see potential applications of this technology extending beyond cancer to include various types of patient-derived tissues, potentially revolutionizing long-term tissue cultivation and monitoring.
“The development of this controllable histotomy technique marks a significant advancement in the field of tissue engineering and drug screening,” said Jiaming Wu, the editor of Engineering. “By leveraging the capabilities of magnetic microneedle array robots, researchers have been able to create a more efficient and precise method for tissue manipulation and analysis.”
POC Saliva Testing Device Predicts Heart Failure in 15 Minutes
Heart failure is a serious condition where the heart muscle is unable to pump sufficient oxygen-rich blood throughout the body. It ranks as a major cause of death globally and is particularly fatal for individuals without access to medical facilities. Traditionally, heart failure is monitored biannually through a blood test that measures B-type natriuretic peptide (BNP) levels, indicating excessive heart strain. Recently, advancements in point-of-care technology aim to revolutionize this approach by introducing simple, at-home saliva tests, allowing frequent monitoring of heart health more regularly than the current every six-month blood test. Until now, the widespread application of portable saliva tests has been hampered by complex production processes and the limited scope of data they can provide, usually restricted to a single biomarker. Now, a team of researchers at Colorado State University (Fort Collins, CO, USA; www.engr.colostate.edu) aims to bring heart
failure screening from clinical settings to the home. The team has developed a point-of-care electrochemical biosensor that works similarly to lateral flow tests like those used for COVID19 but is designed for heart failure detection. This biosensor can analyze two heart failure biomarkers from a drop of saliva in about 15 minutes. Dubbed the electrochemical capillary-driven immunoassay (eCaDI), this device integrates innovations from their previous work—a microfluidic saliva device and a biosensor that detects biomarker proteins Galectin-3 and S100A7.
The eCaDI system consists of five layers arranged like a club sandwich. It includes three layers of transparent, flexible plastic separated by double-sided adhesive. The top plastic layer features small holes for saliva input, and the middle layer contains laser-cut channels that lead to blotting paper, which draws the saliva through these channels. Embedded between
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Graham
Hernán
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
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Rapid Blood Test for Hypothyroidism
including visits to labs and waiting 2 to 5 days for results. Now, a new TSH immunoassay performed on a silicon chip delivers results in approximately 30 minutes.
Genalyte (San Diego, CA, USA; www. genalyte.com) has received U.S. Food and Drug Administration (FDA) approval for its groundbreaking immunoassay, the first of its kind to be cleared for use on a silicon chip-based device. The Maverick Diagnostic System (MDS) incorporates silicon chip-based photonic ring resonator technology, enabling the execution of multiple rapid tests simultaneously from a small sample of whole blood or serum. This system is also connected to the cloud, facilitating the retrieval of assay protocols and enabling clinical oversight. Genalyte’s innovation effectively minimizes the traditional bulky lab machinery
POC Saliva Testing Device Predicts Heart Failure in 15 Minutes
Cont’d from page 4 the plastic layers are glass fiber pads infused with reagents that react with the saliva, measuring the levels of Galectin-3 and S100A7 upon the application of an electrical current. The bottom plastic layer is equipped with carbon ink electrodes, printed to interact with the reagents. These electrodes are connected to a po tentiostat, an external device that supplies the necessary electrical cur rent to trigger the reactions on the reagent pads.
This single-use eCaDI costs ap proximately USD 3 per unit, with the potentiostat, a small, reusable power supply, priced around USD 20. In trials, the device was tested with standardized human saliva spiked with biomarker levels in dicative of heart failure, where it successfully detected the concen trations of Galectin-3 and S100A7. Moving forward, the researchers plan to initiate human subject trials to validate the efficacy of eCaDI in both healthy individuals and pa tients diagnosed with heart failure.
“Our device would be ideal for people who are at high risk for heart failure but have limited access to a hospital or a centralized lab,” said Trey Pittman, a graduate student at Colorado State University. “These demos are a first step towards a robust and non-invasive electro chemical sensor for heart failure biomarkers. This work may provide a starting point for new saliva testing platforms for other diseases.”
to 3% of its original size while still delivering lab-quality results.
The compact Maverick Diagnostic System, comparable in size to a small microwave and weighing just 30 pounds, offers lab-quality results on-site, representing a significant shift in laboratory processing much like the transformation brought by silicon chips in computing. This technology promises to significantly reduce the turnaround time for lab results by 98%, potentially making it available at pointof-care locations in the future. This FDA clearance not only marks a critical achievement for Genalyte but also for the diagnostic industry, confirming the company’s capability to deliver precise and rapid lab results.
“This TSH assay is a powerful tool to rapidly diagnose patients and get them on a path to treatment quicker,” said CEO of Genalyte
of Genalyte)
Ashraf Hanna, Ph.D., M.D. “This technology is groundbreaking for immunoassay development which hasn’t changed conceptually since 1959. The Maverick has the potential to allow a broad menu of blood testing in a small, portable device at the point of care.”
Image: The Maverick system’s silicon chip technology is poised to revolutionize lab care (Photo courtesy
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Automated Benchtop System to Bring Blood Testing Everywhere
Almost all medical decisions are dependent upon laboratory test results, which are essential for disease prevention and the management of chronic illnesses. However, routine blood testing remains limited worldwide. Many adults avoid routine blood tests due to their complexity and the long wait times for results, which can lead to delayed interventions or missed diagnoses, resulting in substantial avoidable costs. Now, a groundbreaking diagnostic platform is set to transform the existing global infrastructure by providing lab-accurate, actionable test results that aid in the early detection and prevention of chronic conditions.
Truvian Health (San Diego, CA, USA; www.truvianhealth.com) has developed an automated benchtop system that allows simple, accurate, and comprehensive routine blood tests to be conducted directly in clinics, doctor’s offices, and pharmacies. Utilizing patented technologies and intelligent integration, Truvian’s compact device offers a convenient and economical alternative to traditional offsite labs, delivering quick, lab-accurate results from just a small blood sample, and enhancing healthcare decision-making. The Truvian
system combines clinical chemistry, immunoassay, and hematology tests in one operation and can simultaneously handle multiple types of assays. Its initial offering, a comprehensive wellness panel, covers over 90% of the most commonly requested routine blood tests, requiring only one tube and 8 drops of blood.
Truvian has shared data from various independent clinical studies showing that its system’s results match those from central laboratories across an extensive range of tests. The platform has been tested with over 50,000 samples from approximately 5,000 donors to date, achieving a reliability rate of over 98%. This system’s capability to provide central lab-quality results in any setting could fundamentally change the way chronic diseases are detected and managed. Immediate access to results enables healthcare providers to diagnose and treat patients without delay, enhancing patient involvement in their health decisions and improving outcomes. By consolidating blood diagnostics into a single visit, the platform reduces healthcare costs for both patients and systems, simplifies the monitoring and management of chronic conditions, and promotes healthier, longer lives. Truvian is
BILIRUBIN-SL ASSAY SEKISUI DIAGNOSTICS
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now working towards securing US Food and Drug Administration (FDA) clearance for its blood testing platform.
“We are on the cusp of delivering what the world needs to counter today’s non-communicable disease burden and unsustainable healthcare costs,” said Jay Srinivasan, chief executive officer of Truvian.
Simple Blood Test Identifies Multiple Myeloma Patients Likely to Benefit from CAR-T
Immunotherapy
Multiple myeloma, a type of blood cancer originating from plasma cells in the bone marrow, sees almost all patients experiencing a relapse at some stage. This means that the cancer returns even after initially successful treatment. For such relapses, Chimeric Antigen Receptor T-cell (CAR-T) immunotherapy is employed, involving the collection and genetic modification of a patient's immune cells to target and destroy
cancer cells. These engineered CAR-T cells are then reintroduced into the patient’s body to attack BCMA, a protein abundantly present in multiple myeloma cells. This method is an active FDA-approved treatment with widespread application. However, until recently, there was no reliable method to predict the efficacy of BCMA CAR-T post-treatment. Now, researchers have developed a simple blood test that counts lymphocytes (a type of white blood
cell) to predict the success of CAR-T immunotherapy in patients with relapsed multiple myeloma. If the treatment is likely to fail, this insight will allow physicians to pursue alternative treatments more quickly.
In a multicenter collaborative study by several notable institutions including Weill Cornell Medicine (New York, NY, USA; www.weill. cornell.edu), researchers observed that patients Cont’d on page 8
Image: The Truvian diagnostic platform combines clinical chemistry, immunoassay and hematology testing in a single run (Photo courtesy of Truvian Health)
Bedside Scanning Device to Enable Slide-Free Pathology for Complete Surgical Tumor Removal
Annually, millions are diagnosed with cancer, with surgical removal being the first treatment option for solid tumors. However, distinguishing tumor margins from healthy tissue during surgery poses a challenge due to insufficient visual contrast. Current practices involve pathologists examining thin sections of tumors under microscopes to examine the borders between cancer and healthy tissue, but this method is time-consuming and only inspects a small portion of
sary cyberinfrastructure to manage extensive data sets required for training the machine-learning models. Furthermore, the team plans to conduct clinical validation of the device and develop versions compliant with FDA regulations.
“Currently, it can take days to weeks before a surgeon knows whether all the tumor has been removed, and our goal is to get
Image: Project leads J. Quincy Brown (left), associate professor of biomedical engineering, and Brian Summa, associate professor of computer science, test a prototype of a new imaging system (Photo courtesy of Tulane University)
tially eliminating the need for additional surgeries. The Tulane research team has been developing this technology with a focus on prostate and colorectal cancers—two of the most challenging tumors to excise—reducing detection time to approximately 45 minutes. They have built a prototype of this groundbreaking system and are now leading efforts to address the remaining technical, computing, and engineering challenges to actualize this device within five years. Efforts are underway to enhance imaging resolution quality and develop the neces-
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The HuMax micro benchtop centrifuge features a maintenance-free brushless induction motor that comes with a rotor and adapters. It has a fixed speed/RCF of 7,000 rpm/2,680 x g and a maximum capacity of 8 x 2 ml / 16 x 0.2 ml.
Diagnostic System to Deliver Same-Shift Antibiotic Susceptibility Test Results
he World Health Organization estimates that sepsis impacts around 49 million people worldwide each year, resulting in roughly 11 million deaths, with about 1.32 million of these deaths directly linked to bacterial antimicrobial resistance. Given the urgency, there’s a growing need for rapid antimicrobial susceptibility testing (AST) that can guide the use of targeted antimicrobial therapies. Such testing is crucial for enhancing patient outcomes, reducing hospital costs, and curbing the rise of antimicrobial resistance. Now, a rapid AST system aims to deliver same-shift results, significantly aiding antimicrobial stewardship teams and clinicians in promptly customizing treatments for patients with severe infections.
The WAVE system from Accelerate Diagnostics (Tucson, AZ, US; www.axdx. com) is designed to deliver rapid AST results from positive blood culture (PBC) bottles and isolated bacterial colonies (isolates), delivering precise results in approximately 4.5 hours. Utilizing cutting-edge holographic im-
aging technology, the WAVE system tracks bacterial growth and morphology changes in real-time, thus allowing for quick, quantitative susceptibility test outcomes. It features a comprehensive test menu and integrates key functionalities to enhance laboratory workflows. The system’s full random access capability supports continuous sample loading, making it adaptable for a wide range of healthcare environments, from small community hospitals to large academic and reference laboratories.
Accelerate Diagnostics has concluded a pre-clinical trial of the WAVE system, which involved a comparative analysis of 1,570 WAVE results against those obtained via broth microdilution, the gold standard reference method. The trial incorporated an equal mix of prospective patient samples and specifically chosen challenge samples, yielding high concordance rates between the different sample types. The trial’s summary data showed an essential agreement and categorical agreement rate of about 95%, demonstrating the system’s effectiveness.
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“We are extremely pleased to announce the goals for our WAVE pre-clinical trial were achieved with strong performance and unprecedented time-to-result of 4.5-hours, on average, along with strong instrument reliability and assay reportability,” said Jack Phillips, President and CEO of Accelerate Diagnostics, Inc. “With the success of the pre-clinical trial we have confidence in both our WAVE product design and the system capabilities to move to a clinical trial and in turn commercialize.”
Simple Blood Test Identifies Multiple Myeloma Patients Likely to Benefit from CAR-T Immunotherapy
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experiencing an increase in their absolute lymphocyte count (ALC) within the first 15 days post-CAR-T infusion showed a greater likelihood of complete response and extended progression-free survival compared to those with lower ALCs on day 15. This study, published in the journal Blood Advances on May 22, analyzed data from 156 patients treated with BCMA-CAR-T therapy between 2017 and 2023 for relapsed multiple myeloma across three medical centers. The patients’ ALCs were measured five days prior to and throughout the
first 15 days following BCMA CAR-T treatment.
The findings indicated that patients with higher ALC at day 15 had a significantly better response to treatment with their cancer under control for an average of 30 months, whereas those with lower counts typically experienced only six months of progression-free survival. Laboratory analyses suggested that a higher ALC might indicate more effective proliferation and activity of BCMA CAR-T cells in the body, potentially explaining why the cancer was kept in check. The researchers are now investigating strategies to boost BCMA CAR-T
cell performance in patients presenting lower ALCs to enhance treatment outcomes.
“If doctors can identify patients who are more likely to have a poor response to BCMA CAR-T, other treatments can be explored or given earlier,” said lead author Dr. Mateo Mejia Saldarriaga, assistant professor of medicine in the Division of Hematology and Medical Oncology at Weill Cornell Medicine and an oncologist at NewYork-Presbyterian/ Weill Cornell Medical Center. “The treatment has been a great tool, but there is still room for improvement.”
Image: The Accelerate WAVE system delivers rapid AST directly from positive blood culture bottles (Photo courtesy of Accelerate Diagnostics)
3D Pathology with AI to Enhance Prognosis Accuracy for Barrett’s Esophagus Patients
BImage: Examples of AI-triaged 3D image sections of a biopsy show how 3D pathology (left) upgraded the diagnosis compared with conventional 2-dimensional methods (right) (Photo courtesy of UW College of Engineering)
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Blood-Based Diagnosis Detects Prenatal Exposure to Birth Disorders
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historically been challenging to detect.
The first study, conducted by the team at London Health Sciences Centre (LHSC, London, ON, Canada; www.lawsonresearch.ca) that developed EpiSign, demonstrated its efficacy in identifying a group of birth disorders known as recurrent constellation of embryonic malformations (RCEMs). Despite being recognized for over seven decades, the specific causes and diagnostic markers for RCEMs have remained elusive, making it difficult to provide accurate diagnosis to affected families. EpiSign now offers a groundbreaking method to accurately detect RCEMs using just a blood test.
In the second study, the same research team applied EpiSign to identify a reliable biomarker for fetal valproate syndrome for the first time. This syndrome results from prenatal exposure to high levels of medications used in managing bipolar disorder, migraines, or epilepsy, leading to a range of neurodevelopmental issues in children, such as learning disabilities, communication and motor disorders, autism, and intellectual disabilities. This research is part of an ongoing effort by the EpiSign Discovery Research network, which is expanding to study and develop biomarkers for over 700 rare disorders. The team has highlighted the vast potential of this research, which could extend to diagnosing, prognosing, and treating a wide array of other conditions, including cancer.
“One in 20 people have a rare disease that could present at any point in their lives and can be caused by genes, environmental exposures, or their combined effects,” said Dr. Bekim Sadikovic, Lawson Scientist at LHSC, who developed the EpiSign technology. “We can help diagnose a growing number of genetic diseases and, now for the first time, we can look beyond the genome and accurately measure the impact of the environment.”
AI Improves Lung Cancer Diagnosis
traditional microscopes obsolete. Tissue samples are now digitized and analyzed via computer screens, which is essential for employing sophisticated artificial intelligence (AI)-based analytical methods. These AI technologies can extract additional insights from pathological tissue sections that were previously unattainable. A team of researchers at the University of Cologne (Cologne, Germany; portal.unikoeln.de) has developed an AI-driven digital pathology platform that can revolutionize the analysis of lung cancer tissues. This platform utilizes newly developed algorithms to perform fully automated examination of digitized lung cancer tissue sections, offering faster and more precise analyses than traditional methods. Detailed in their publication in the journal Cell Reports Medicine, the platform is founded on the most extensive and high-quality dataset available, enabling it to process H&E-stained whole-slide images (WSIs) of both resection and biopsy specimens from non-small cell lung cancer (NSCLC) patients. It can accurately segment all relevant tumor and benign tissue classes at the pixel level.
The core of this platform is a cutting-edge multi-class tissue segmentation algorithm, marking a significant leap in the accuracy and precision of lung cancer pathology. This development is among a handful of published studies that focus on tissue detection and classification in WSIs from lung cancer patients. Furthermore, the research team has identified four prognostic parameters that have proven effective in stratifying NSCLC patients prognostically, which could be crucial for determining patient eligibility for adjuvant therapy following surgery. To support ongoing academic research and enhance algorithm development and benchmarking, the team has made four of their annotated test datasets publicly available. This innovative platform is poised to transform various diagnostic, prognostic, and predictive applications within the field.
Image: The new AI-based digital platform enables extremely fast and accurate analysis of tissue sections from lung cancer patients (Photo courtesy of Dr. Yuri Tolkach)
sician Dr. Yuri Tolkach from the Institute of General Pathology and Pathological Anatomy at University Hospital Cologne, who led the study. “The new tools can not only improve the quality of diagnosis, but also provide new types of information about the patient’s disease, such as how the patient is responding to treatment.”
“We also show how the platform could be used to develop new clinical tools,” said phy-
Motor neuron disease (MND), also referred to as amyotrophic lateral sclerosis (ALS), is a debilitating condition where messages from the brain’s motor neurons fail to reach the muscles, resulting in muscle weakening. At present, there is no cure for MND. Now, researchers have developed a new imaging technique to detect pathological abnormalities linked to MND, which could enhance the understanding of brain changes responsible for the disease and potentially aid in developing new treatments.
This advancement was highlighted in a study published in Nature Communications, a collaborative effort between the University of Birmingham (Birmingham, UK; www. birmingham.ac.uk) and the University of Sheffield (Sheffield, UK; www.sheffield.ac .uk/sitran). Researchers at the University of Birmingham developed the new method called native ambient mass spectrometry (NAMS), allowing them to analyze proteins in their natural state directly from brain and spinal cord tissue samples. This technique provides unprecedented detail in studying protein structures in relation to their location within the tissue.
Working in collaboration with colleagues at the University of Sheffield, the team discovered a metal deficiency in a protein known as SOD1 and showed that it accumulates in specific areas of the brain and spinal cord in mice with MND. SOD1 has been previously linked to MND, but this research marks the first instance of detailed molecular imaging demonstrating how variants
of this protein, lacking metal ions, accumulate in mice affected by the disease. Future research will aim to confirm if these imbalances also occur in human tissues and will explore potential treatments for these imbalances using existing drugs.
“This approach is the first to show that this form of SOD1 correlates with the pathology of motor neuron disease,” said lead researcher Helen Cooper from Birmingham’s School of Biosciences. “It’s a very early step towards find ing treatments for MND and is also an exciting new route for understanding the molecular basis of other diseases in unprecedented detail.”
“We were very excited to apply this fantastic methodology which Helen’s team have devel oped to gain new insights into the biology of MND and we look forward to using the technol ogy further to explore why motor neurons die and find new interventions for those affected by MND,” added Richard Mead from the Sheffield Institute for Translational Neuroscience.
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Image: The new imaging technique has revealed protein flaw in motor neuron disease (Photo courtesy of University of Birmingham)
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Earlier Detection of Pancreatic Cancer
curacy, fulfilling this need and potentially boosting survival rates for these patients.
Immunovia AB (Lund, Sweden; www. immunovia.com) has reported enhanced outcomes for its next-generation test aimed at detecting early-stage PDAC in high-risk individuals. In April 2024, the company shared positive outcomes from the preliminary model-development study of its innovative pancreatic cancer detection test. This study incorporated 624 patient samples collected from 13 distinct clinical sites, including 129 samples from patients diagnosed with stage 1 or 2 PDAC and 495 control samples, primarily from individuals at elevated risk for hereditary and/or familial pancreatic cancer. The control group also included individuals with pancreatic cysts, diabetics, and healthy subjects.
The test’s performance was refined through the inclusion of additional samples, which
Aprovided more comprehensive and specific clinical data, and the application of advanced statistical modeling techniques. These improvements have significantly increased the test’s accuracy, boosting the sensitivity of this next-generation test to 85% and its specificity to 98% for detecting stage 1 and 2 PDAC. A sensitivity rate of 85% indicates that the test can identify pancreatic cancer in about six out of every seven people with early-stage disease. A specificity rate of 98% means that only about one in every 50 people tested who do not have pancreatic cancer would receive a false positive result.
“We have now completed research and development efforts for our next-generation test and are thrilled with the accuracy of the test,” said Jeff Borcherding, CEO of Immunovia. “This is a critical milestone for the company. Our next-generation test shows tremendous promise for improving pancreatic
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cancer surveillance with a highly accurate, convenient and affordable test. We are very optimistic about the clinical impact of the test when we launch in the U.S. in 2025.”
Simple Blood Test Can Identify People with Higher Risk of Stroke
trial fibrillation is the most prevalent cardiac arrhythmia, affecting approximately one-third of all individuals at some point in their lives. It is a common cause of stroke because it increases the risk of blood clots forming in the heart’s atria. Consequently, many individuals with atrial fibrillation receive anticoagulation therapy to prevent strokes. However, due to the heightened risk of serious hemorrhages from anticoagulation, only those with a moderate or high stroke risk are treated, not everyone with the condition. Therefore, accurately identifying those who would benefit from anticoagulation is crucial. While blood tests are routinely used in healthcare to assess organ function, including the heart, kidneys, and liver, no standard blood test exists to evaluate brain health in relation to cardiovascular disease. Researchers have now shown that a
simple blood test reflecting brain health can determine which individuals are at increased stroke risk. This breakthrough could lead to more personalized treatment for patients with atrial fibrillation.
Researchers at Uppsala University (Uppsala, Sweden; www.uu.se) studied the neurofilament protein, which is released from the brain under stress or low oxygen conditions, in blood samples from over 3000 individuals with atrial fibrillation. They monitored these individuals for an average of 18 months. Those with the highest levels of neurofilament in their blood were found to face the highest stroke risk. According to findings published in the journal Circulation, the risk of stroke for the quarter with the highest neurofilament levels was more than triple that of those with the lowest
levels. Adding neurofilament measurements to standard cardiac blood tests from the same patients further improved stroke prediction. The next research steps will explore how various healthcare treatments affect neurofilament levels and whether this impacts the risk of stroke or death.
“We hope to be able to intervene at an earlier stage and inhibit injurious strain on the brain before it gives rise to symptoms,” said Julia Aulin, a cardiologist at Uppsala University Hospital and researcher at Uppsala University, the lead author of the study. “The findings are probably transferrable to other groups of patients with cardiovascular-related disorders, though this remains to be demonstrated. Our hope is that it will ultimately be possible to assess brain health with a simple blood test at the local health center.”
Image: The simple blood-based test can detect proteins and antibodies that indicate a high-risk individual has developed pancreatic cancer (Photo courtesy of Immunovia)
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Blood Test Predicts Alzheimer’s With Over 90% Accuracy
nal fluid tests, there is a significant need for simpler, quicker diagnostic tools that can be used in primary care. Now, a commercially available blood test has demonstrated approximately 90% reliability in primary care settings, representing a major development for individuals seeking assistance for memory loss and potential Alzheimer’s.
The PrecivityAD2 test, developed by C2N Diagnostics (St. Louis, MO, USA; www.c2n. com) requires a single blood sample and uses high-resolution mass spectrometry to accurately measure proteins in the blood associated with the likelihood of amyloid plaques in the brain, a key pathological indicator of Alzheimer’s disease. This test utilizes a rigorously validated algorithm that combines plasma Aβ42/40 and p-tau217/np-tau217 (%p-tau217) ratios. It delivers clear positive or negative results, indicating a high or low probability of brain amyloid pathology. Research into this cutting-edge blood test began in 2019, with studies showing that the PrecivityAD2 test can detect Alzheimer’s-related changes even before symptoms emerge and track disease progression. Earlier this year, results indicated that this blood test is as reliable as, and sometimes better than, cerebrospinal fluid tests for diagnosing the disease.
A
The latest study conducted at Lund University (Lund, Sweden; www.lunduniversity.lu.se) and published in the renowned journal JAMA, is the first to evaluate the reliability of the PrecivityAD2 test in routine healthcare settings, including both primary and specialist healthcare. The study involved 1,213 individuals with mild memory symptoms, which may be an early indicator of Alzheimer’s. Of these participants, 515 were assessed in primary care and 698 in specialist memory clinics. Participants underwent the blood test, and the results were later validated through cerebrospinal fluid tests that detect Alzheimer’s disease pathology. PrecivityAD2’s reliability for identifying Alzheimer’s disease was about 90%, which was then compared with the diagnostic accuracy of doctors in primary or specialist care before they had access to the results of the blood or cerebrospinal fluid tests. Accuracy rates for diagnosing Alzheimer’s disease were 61% among primary care doctors and 73% among specialists. The simplicity and accuracy of this blood test represent significant progress in diagnosing Alzheimer’s, providing a straightforward way to exclude the disease in primary care settings. This is vital since memory loss can also arise from other treatable conditions such as depression or chronic fatigue.
“The next steps include establishing clear clinical guidelines for the blood test’s use in
AI-Based Analysis Method Uncovers New Insight into ALS Progression
myotrophic Lateral Sclerosis (ALS) is a fatal condition where motor neurons, which are crucial for controlling movement, progressively die. Currently, there is no cure for ALS, and patients typically live between 2 and 5 years after diagnosis. Now, in a new study published in Science Advances, researchers have shown how to leverage artificial intelligence (AI) to gain deeper insights into ALS progression.
The study, led by researchers from the School of Psychology and Neuroscience at the University of St Andrews (Scotland, UK; www. st-andrews.ac.uk), in collaboration with the Department of Neuroscience, University of Copenhagen (Copenhagen, Denmark; www. ku.dk), found that certain neural circuits that control movement are compromised early in the disease, while others deteriorate later as the disease progresses. The techniques used in the study allow for the simultaneous analysis of multiple cell types within the spinal cord, enhanced by an innovative AI-driven analytical method. This enabled the identification of specific networks of cells that are impacted early in the disease process before the motor neurons actually die. These networks include subgroups of inhibitory interneurons, which are essential for activating motor neurons that control movements like walking and running.
The findings indicate that different types of cells, namely inhibitory and excitatory interneurons which regulate various movement aspects by activating motor neurons, are affected at different stages of ALS. Inhibitory interneurons are impacted early in the disease, while excitatory interneurons suffer as the disease progresses. The AI-based method developed by the team improves the quantification of this data. Their approach uses advanced techniques to identify which cell types are key contributors to the disease. These cells are notably diverse and mixed within the spinal cord, making them challenging to study
Cont’d on page 14
Image: Neurofibrillary tangles in pyramidal neurons, a characteristic neuropathological lesion of Alzheimer’s disease (Jose Luis Calvo/Shutterstock)
healthcare,” said Professor Oskar Hansson from Lund University who co-led the study. “The test is already available in the USA and is likely to become available in many other countries soon. Initially, it will mainly be used in specialist memory clinics, and it may take approximately one to two years to implement guidelines and training in primary care.”
Image: Spinal cord neurons (Photo courtesy of University of St Andrews)
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with Inflammation in Real Time
nflammation, a natural immune response, increases blood flow and improves cellular defense against diseases and infections. Rapid detection of inflammation is critical for effective treatment, creating the need for quick tests for inflammatory biomarkers like C-reactive protein (CRP). Produced in the liver, CRP is released into the bloodstream as part of the immune response and acts as a marker of inflammation and infection. It has been used historically to diagnose inflammation, but its broader potential as a biomarker for various diseases is a relatively recent development. Monitoring CRP levels can help diagnose severe conditions such as trauma, sepsis, ischemic necrosis, and malignancies. Although it is an acute phase reactant, tracking its levels over time is necessary to assess the effectiveness of treatments. Despite advancements in medical diagnostics, current methods to measure CRP levels lack the speed and immediacy needed for optimal care.
INow, researchers from the Institute of Physical Chemistry (ICHF) at the Polish Academy of Sciences (Warsaw, Poland; www.ichf.edu.pl) have developed a novel point-of-care device that measures CRP levels quickly and accurately, enhancing the speed and cost-effectiveness of analyses. This device, the size of a credit card, integrates electrochemical biosensors with near-field communication (NFC) technology within a microfluidic system. It requires only a small sample placed on a microfluidic plate with a tiny electrode. The sample moves through the device via capillary action, eliminating the need for external pumps and allowing automatic flow.
The device performs measurements electrochemically using a portable potentiostat. CRP detection occurs on specially designed electrodes within the microfluidic channels. These electrodes are coated with antiCRP nanobodies—small antibody fragments that offer high specificity and stability under various conditions, making them ideal for detecting even low concentrations of antigens. The use of nanobodies enhances the sensitivity of the measurements, providing a balance between analytical accuracy and quick analysis times.
Results are displayed on Android smartphones, allowing real-time data collection and analysis. This biosensor captures and quantifies CRP as effectively as traditional, more expensive methods like ELISA tests. Offering greater sensitivity and stability, the device enables real-time measurements that greatly expand its utility in clinical settings. It provides a user-friendly, rapid, and affordable diagnostic tool that facilitates immediate treatment decisions, thus improving patient outcomes. This development marks a significant advance towards modern, personalized healthcare, allowing for quicker diagnoses and better monitoring of treatment efficacy.
CALPROTECTIN ONE STEP CARD TEST CERTEST BIOTEC
CerTest Calprotectin one-step card test is a colored chromatographic immunoassay for the semi-quantitative detection of human calprotectin (hCp) in stool samples that may reflect gastrointestinal inflammation.
“The proposed method was applied to the detection of CRP in whole human blood obtained from anonymous donors,” said Professor Martin Jönsson-Niedziółka who led the study. “The experimental results showed that the NFC-based system integrated with the flow-through microfluidic device can correctly quantify CRP in clinically relevant biological samples without the need for pretreatment procedures and could therefore be used for the assessment of inflammation, infections caused by bacteria or viruses, and monitor for increased risk of heart disease.”
AI-Based Analysis Method Uncovers New Insight into ALS Progression
Cont’d from page 13
simultaneously. The AI model developed by the team helps overcome these challenges and sheds light on new potential treatment targets. This methodology is available online, aiming to support further research in this field.
“We used techniques that allow us to visualize and quantify multiple genes at the same time with single cell resolution in the spinal cord of the ALS mouse model”, said lead researcher Dr Ilary Allodi, lecturer in Systems Neuroscience at the School of Psychology and Neuroscience. “Each cell type can be identified by a specific set of genes, but these genes need to be visualized simultaneously. By using these transcriptomic techniques, we were able to differentiate between inhibitory and excitatory populations and among their subpopulations. This allowed us to investigate their fate during different stages of disease progression.”
Image: Schematic illustration of the developed sensor obtained by combining the microfluidic device with a smartphone-based potentiostat (Photo courtesy of ACS Sensors (2024). DOI: 10.1021/acssensors.4c00249)
Simpler, Faster Testing Technology to Boost Early Detection of Lyme Disease
Lyme disease, transmitted to humans through tick bites, presents a diagnostic challenge due to its initial vague symptoms such as headaches, pain, and fatigue, which may evolve into a severe, long-term inflammatory condition affecting the joints, nerves, brain, and heart. This complex immune response can often be confused with other dangerous tick-borne infections, complicating the initiation of appropriate antibiotic treatments. While antibiotics do not guarantee a cure, they are effective in preventing the progression of the disease in 80% to 90% of cases if administered early. Currently, the definitive diagnosis of Lyme disease relies on a two-stage laboratory test, which can take up to two weeks to deliver results and frequently fails to detect early-stage infections. Now, a new testing approach utilizing artificial intelligence (AI) technology has demonstrated efficacy in accurately diagnosing Lyme disease within 20 minutes with a single test.
The Lyme disease detection technology developed by researchers at the California NanoSystems Institute at UCLA (Los Angeles, CA, USA; www.cnsi.ucla.edu) operates similarly to at-home COVID19 tests. It produces results within 20 minutes, interpreted by a portable AI-powered reader. In this technology, a blood serum sample is introduced into a cartridge along with a buffer solution, initiating a vertical flow through several sponge-like paper layers. One such layer is embedded with synthetic peptides—protein building blocks from Lyme disease bacteria—that capture specific antibodies produced in response to the infection. The emerging pattern, indicative of the presence and concentration of these antibodies, is captured by a digital reader and analyzed by an AI algorithm to provide a diagnosis.
In the study published in Nature Communications, the researchers validated the effectiveness of this single-test approach against the conventional two-test method for Lyme disease. The researchers trained their AI algorithm using diverse patient samples, including those from early-stage Lyme disease and conducted blind tests to evaluate their technology. They reported a 95.5% sensitivity in detecting Lyme disease and a 100% specificity in identifying negative samples. When compared with standard laboratory tests, this point-of-care test aligned well, effectively identifying Lyme disease and distinguishing it from similar conditions.
The testing materials are cost-effective, with each test paper priced at USD 3 and the reader adapted from a commercially available smartphone costing USD 200. The quick, portable, and affordable nature of this testing method offers the potential for immediate Lyme disease diagnosis directly at the point of care. This development represents a significant advancement in rapid diagnostic technologies that accurately profile the human immune response to infections. The researchers are now focusing on adapting this test for use with whole blood samples and streamlining the test format. Plans are also underway to create a dedicated AI sample reader, independent of smartphones. Further development and testing could lead to clinical availability within a few years.
“A lot of folks find out they have Lyme disease well after the point at which they could have been treated very easily,” said co-corresponding author Dino Di Carlo, the Armond and Elena Hairapetian, Professor of Engineering and Medicine in the UCLA Samueli School of Engineering. “If we can measure rapidly, in a way that’s cost-effective and not a burden to the health system and the patient, then testing can be done more routinely. If you were out in the woods and have signs of a tick bite or other symptoms, it might be prudent to quickly test either at home or the local clinic, which could enable potential treatment earlier.”
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Image: Diagram showing steps to a Lyme disease test (Photo courtesy of Rajesh Ghosh/UCLA)
The UriSed mini urine analyzer offers a throughput of up to 60 T/H, total measurement cycle less than one minute. Cost-effective operation without liquid reagents or calibrators makes it ideal for various medical/ clinical settings.
AI Automates Analysis of Pathology Slides for Distinguishing Rheumatoid Arthritis Subtypes
Rheumatoid arthritis (RA) is a complex immune-mediated inflammatory disorder characterized by inflammatoryerosive arthritis. Recent advancements in understanding the histopathological diversity of RA synovial tissue have identified three distinct phenotypes based on cellular composition, highlighting the need for targeted therapeutic approaches. Currently, pathologists manually categorize arthritis subtypes by analyzing cell and tissue characteristics in human biopsy samples, a process that is both time-consuming and costly, potentially leading to inconsistencies in diagnosis. To address these challenges, a new machine-learning tool has been developed to enhance the accuracy and efficiency of RA phenotyping in both preclinical and clinical settings.
In their study published August 29 in Nature Communications, investigators at Weill Cornell Medicine (New York, NY, USA; www. weill.cornell.edu) and Hospital for Special Surgery (HSS, New York, NY, USA; www.hss.edu) demonstrated the capability of artificial intelligence (AI) and machine learning technologies to effectively subtype pathology samples from RA patients. This differentiation among the RA subtypes can guide clinicians in selecting the most appropriate therapy for individual patients. Initially, the team trained the algorithm using samples from a specific mouse model, optimizing its ability to identify and categorize tissue and cell types into subtypes. This algorithm was then validated with another set of samples, revealing its potential to track treatment impacts, such as reduced cartilage degradation after six weeks of standard RA treatments. Subsequently, the tool was applied to human biopsy samples, where it proved to be both effective and efficient in classifying clinical
The Allplex GI-Bacteria(I) Assay is a multiplex real-time PCR assay. Based on Seegene’s proprietary MuDT technology, it detects and identifies 7 causative bacterial pathogens in gastrointestinal tract infection.
Image: The machine learning model can predict lymphocyte cells with high accuracy on H&E histology slides (Photo courtesy of Bell and Brindel, et al., 2024)
samples. The researchers are continuing to validate this tool with additional patient samples and exploring optimal ways to integrate it into existing pathological workflows. This technology not only promises to streamline the subtyping process, thereby reducing research costs and enhancing the efficacy of clinical trials, but also offers novel insights into RA by identifying tissue changes that might be overlooked by human observers. Ongoing development efforts by the researchers aim to create similar diagnostic tools for other conditions like osteoarthritis, disc degeneration, and tendinopathy, and extend machine learning applications to identify subtypes of other diseases, such as Parkinson’s disease, based on broader biomedical data sets.
“Our tool automates the analysis of pathology slides, which may one day lead to more precise and efficient disease diagnosis and personalized treatment for RA,” said Dr. Fei Wang, a professor of population health sciences and the founding director of the Institute of AI for Digital Health (AIDH) in the Department of Population Health Sciences at Weill Cornell Medicine. “It shows that machine learning can potentially transform pathological assessment of many diseases.”
“By integrating pathology slides with clinical information, this tool demonstrates AI’s growing impact in advancing personalized medicine,” added Dr. Rainu Kaushal, senior associate dean for clinical research and chair of the Department of Population Health Sciences at Weill Cornell Medicine. “This research is particularly exciting as it opens new pathways for detection and treatment, making significant strides in how we understand and care for people with rheumatoid arthritis.”
Edited by Katherina Psarra, MSc, PhD
MESSAGE FROM THE PRESIDENT
By Tomris Ozben • President, IFCC
Dear
Colleagues and Friends,
I hope this message finds you well. I’m pleased to share some key updates from the IFCC, as our activities continued to thrive even during the summer months.
I would like to start with a reminder. As you are aware, the EuroMedLab congress is the premier event in European Laboratory Medicine, held every two years. In 2023, it was held in Rome, Italy and in 2025, it will be held in Brussels, Belgium. IFCC and EFLM distributed the invite to formal bids from the European National Societies to host the EuroMedLab 2027. The selection of the host city for EuroMedLab 2027 is made by the respective IFCC and EFLM Executive Boards and Congress Committees. All applications were to be submitted by September 30, 2024. We look forward to selecting the best venue for the 2027 EuroMedLab Congress of Clinical Chemistry and Laboratory Medicine!
The IFCC Office and Functional Units have resumed their activities following a refreshing summer break. The IFCC Executive Board and Divisions are planning their fall meetings to advance the IFCC programs and strategic initiatives across various fields of action.
The recently founded IFCC Accreditation Working Group, chaired by Dr. David Kinniburgh (Canada), will continue its activities as a committee belonging directly to the IFCC Executive Board. We wish the IFCC Accreditation Committee members a successful working term and expecting to use accreditation programs of the committee in the IFCC educational activities and IFCC congresses.
As I mentioned in my previous Message, several national society meetings have begun to be organized in person starting this September. These meetings are crucial for laboratory professionals, providing essential platforms for knowledge exchange, professional development, and networking. The IFCC supports congresses, conferences, IFCC Corporate Member webinars, and other scientific and educational events, assisting organizing committees in promoting their events and attracting professional participation.
I personally attended two national society meetings in September. The first was the 17th Baltic Congress of Laboratory Medicine, held in Vilnius, the beautiful UNESCO World Heritage city, from September 5-7, 2024. Most participants were from the three Baltic societies: Lithuania, Estonia, and Latvia. I would like to congratulate the Organizing Committee and Chair Prof. Dalius Vitkus for hosting a highly successful congress, both scientifically and socially. The program was comprehensive, attendance was high, and the enthusiasm for the scientific sessions was remarkable, reflecting a strong interest in the scientific program topics and speakers.
The second national society meeting I attended was the XIII Serbian Congress of Medical Biochemistry and Laboratory Medicine, which took place from September 16-18 in Belgrade. I would like to congratulate Prof. Nada Singh, Doc. Dr. Snežana Jovičić, and Doc. Dr. Neda Milinković for their kind invitation and for organizing an excellent scientific program that included nine sections and two plenary lectures. The focus of the congress was on the innovations and trends shaping the future of laboratory medicine.
I am pleased to inform you that the Executive Board of the Society of Medical Biochemistry of Serbia has awarded me an Honorary Diploma in recognition of my extraordinary contributions to promoting Clinical Chemistry and Laboratory Medicine in Europe and globally. This honour brings me great pleasure and motivates
me to continue dedicating my time and efforts to the field of laboratory medicine.
I was invited to attend the World Patient Safety Day 2024 Global Consultation ‘Improving diagnostic safety and implementing the Global Patient Safety Action Plan 2021-2030’ that was held on 1012 September 2024 in Geneva, Switzerland. I attended this important meeting organized by the World Health Organization as the President of the biggest global federation of Laboratory Medicine. I presented a talk emphasizing our responsibility to provide accurate and timely health services to patients and clinicians, as diagnoses are primarily based on laboratory data. I also discussed the origins of errors in laboratory data and outlined strategies to avoid and minimize these errors.
As you know, IFCC webinars offer high-quality learning opportunities and support the continuous professional development of laboratory professionals. There is significant interest in these webinars. Below is the list of September and October webinars. They are available on demand after their presentation dates.
DATE
September 4
September 18
September 23
October 4th
October 16
October 28th
CHAIR / MODERATOR
Raul Girardi
Eduardo Freggiaro
Kristin Moberg Aakre
Tahir Pillay
Elie Fux
Adil Khan
TITLE
Minimum quality specifications based on the state of the Art / Especificaciones mínimas de Calidad basadas en el estado del arte
Future challenges of Laborator Medicine / Desafíos futuro de la Medicina de Laboratorio
Current and future perspectives on measuring natriuretic peptides
Derived lipid profile parameters: navigating the data
The potential of metabolomics to tackle unmet clinical needs
Point-of-Care Testing: The never-ending challenges and their resolutions
As we look ahead to 2025, I would like to highlight the 26th European Congress of Clinical Chemistry and Laboratory Medicine (EuroMedLab) hosted by the Royal Belgian Society of Laboratory Medicine (RBSLM) in conjunction with their 49th Annual Congress. The event will take place in the vibrant capital of Belgium, Brussels, from May 18-22, 2025. This congress will provide a global forum for the open exchange of information on the science and technology of clinical chemistry and laboratory medicine across academic, clinical, and industrial settings.
The next IFCC General Conference (GC) is scheduled for May 16th and 17th, 2025 (Friday and Saturday), in Bruges, Belgium, ahead of the EuroMedLab Congress. We anticipate strong interest in the General Conference, which will bring together IFCC officers, representatives from IFCC Regional Federations, National Societies, and Corporate Members. Together, we will discuss the current status of Laboratory Medicine, as well as the challenges and innovations shaping its future.
We greatly appreciate your continued dedication and contributions to the IFCC community and look forward to connecting with you in the next edition of eNews.
With my best regards Prof. Dr Tomris Ozben IFCC President
IFCC Taskforce on Outcome Studies in Laboratory Medicine (IFCC TF-OSLM) Announces Podcast Series
The
IFCC Task Force OSLM is excited to announce the launch of a podcast series on Outcome Studies in Laboratory Medicine. The series serves to provide practical tips and helpful guidance to assist the laboratorian/clinician to engage with and perform laboratory focused outcome studies. Each podcast will be with an expert in the field or investigators whose outcome studies have served as excellent examples of how laboratory outcome studies can be performed.
Our first guest in the podcast series is Prof. Tony Badrick. Prof. Badrick is currently the CEO of the RCPAQAP since 2015. He is an Adjunct Prof. at the School of Pharmacy and Pharmacology, Griffith University, Gold Coast; Honorary Assoc. Prof., National Centre for Epi-
demiology and Public Health Australian National University College of Health and Medicine; Honorary Assoc. Prof., Faculty of Medicine, Bond University, Gold Coast; and Visiting Fellow, Australian Institute for Health Innovation, Macquarie University. He was also President of the Australasian Association of Clinical Biochemists (2003-2007), Chair of the Faculty of Science RCPA (20122018) and is Chair of the Education and Laboratory Management Committee of the Asian Pacific Federation of Clinical Biochemistry. Prof Badrick is also the regional IFCC representative for Asia-Pacific region.
Click on the link to listen to Prof Badrick’s podcast: https://eacademy.ifcc. org/courses/assessing-and-reviewingtest-clinical-utility
Opportunity Awaits: Apply Today for Global Recognition
The UNIVANTS of Healthcare Excellence award program has long been associated with best practices of measurably better healthcare. With over 76 best practices recognized thus far, the program is an inspirational call to action for healthcare teams to apply. This year is no different. Now in year 6, the program has opened the award application process once again. This means, if you are a passionate healthcare professional who collaborates, innovates and measures improvements of strategic initiatives, then now is the time to apply for global recognition through the UNIVANTS of Healthcare Excellence award program.
To be eligible for potential recognition, submitted application must meet the below eligibility criteria:
1. The clinical care initiative must be implemented into clinical practice.
2. The metrics must fall under a singular clinical care effort.
3. The clinical care initiative must include at least three disciplines (including Laboratory Medicine/Pathology).
4. There must be at least one measurable impact or Key Performance Indicator (KPI) associated with each of the four stakeholders: patients, clinicians, health systems/ administration, and payors.
5. Impact can be assessed quantitatively (preferred) or qualitatively, but there must be at least two quantitative metrics and no more than four qualitative metrics.
The UNIVANTS of Healthcare Excellence award program is run in partnership with Abbott, International Federation of Clinical Chemistry (IFCC), Association for Diagnosis and Laboratory Medicine (ADLM), 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).
Applications for the 2025 UNIVANTS of Healthcare Excellence awards are now possible through until Nov 15, 2024. Applications are open to all integrated clinical care teams and are free to apply. Applications must be free from bias, without any reference to products and/or manufactures. To submit your application today and/or learn about past winners, please visit the UNIVANTS website. For questions, please reach out to UnivantsOfHealthcareExcellence@ abbott.com.
IFCC OFFICE
Via Carlo Farini 81, 20159 Milan, ITALY Tel: (39) 02-6680-9912 • E-mail: ifcc@ifcc.org Web: www.ifcc.org
Mass Spectrometry Meets Clinical Laboratories: Athens, Nov. 8-10, 2024
Onbehalf of the IFCC Scientific Division and the Greek Society of Clinical Chemistry–Clinical Biochemistry, we have the pleasure of announcing a joint Clinical Mass Spectrometry congress for diagnostic purposes. The Congress title of this event is “Mass Spectrometry Meets Clinical Laboratories”. The conference will be held as a hybrid (physical presence and virtual) facilitating colleagues who cannot attend in person and enjoy the superb Athens atmosphere at this time of the year.
The congress will take place in the center of Athens. Many of the most important Athens museums are within walking distance, and the Acropolis of Athens is just two metro stops from the congress site.
Congress of the Greek Society of Clinical Chemistry–Clinical Biochemistry, but for the lectures presented in Greek there will be simultaneous translation into English.
The main topics to be covered are the following:
Mass spectrometry in the clinical laboratory: What is it about?
LC-MS/MS in TDM (therapeutic drug monitoring): Addressing new clinical needs fast
LC-MS/MS applications in Endocrinology: Improving the diagnosis and treatment of endocrine diseases
Manufacturer’s viewpoint on the future of mass spectrometry in diagnostics
Ensuring the quality of measurements for mass spectrometry assays: Is there anything special?
But the most important is the congress program which includes all the existing information of this exciting technology, introduced more and more in clinical laboratories. Distinguished scientists from all over the world will speak about all the clinical applications regarding mass spectrometry. The two last days of the congress will be included in the 22nd National
Mass spectrometry as a new tool in the laboratory portfolio: Is it value for money?
Clinical mass spectrometry: Beyond small molecules – Quo Vadis?
As mentioned before, more lectures will be presented during the 22nd National Congress of Greek Society of Clinical Chemistry–Clinical Biochemistry with simultaneous translation into Eng-
lish and with more topics on the use of mass spectrometry like biomarkers of metabolomics, newborn screening, the measurement of vitamins and their metabolites (focus on vitamin D metabolites), sickle cell disease, and coronary artery disease.
At the end of these 4 days, participants will have acquired a lot of knowledge on mass spectrometry and its clinical applications. As the organizers say in their welcome address:
“The success of the congress will depend largely on your cooperation and participation!”. International Congress to be held in conjunction with the IFCC Scientific Division (IFCC SD)
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Acustomizable point-of-care (POC) lateral flow reader combines advanced imaging technology and proprietary algorithms to deliver high-sensitivity measurements in just 10 seconds.
The miniDxR lateral flow reader designed by DCN Dx (Carlsbad, CA, USA; www.dcndx.com) for POC testing offers advanced imaging technology, superior sensitivity and specificity, and robust cybersecurity features. It is customizable for diverse diagnostic applications, providing reliable and accurate results in diverse POC settings. The miniDxR utilizes advanced camera-based colorimetry and fluorescence for accurate and precise color and intensity detection, vital for the most sensitive POC diagnostics. It features a modular cartridge nest that can be customized to accommodate a wide variety of lateral flow assay cassettes, ensuring compatibility with a laboratory’s specific needs.
The miniDxR boasts a user-friendly interface with a vibrant color display and simple three-button control, enabling effortless operation even in fast-paced POC environments and while using gloves. Additional options are available to adapt screen size and button controls. It offers versatile “batch” and “single test” modes to accommodate diverse testing protocols, allowing labs to analyze pre-run assays or monitor lateral flow assays in real-time at the POC. Additionally, the miniDxR safeguards sensitive data with robust encryption and adheres to rigorous
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The miniDxR offers a variety of customization options, from software workflows and data presentation to hardware modifications and branding. Every customized miniDxR unit comes with standard features such as presubmission materials, product and software requirements, risk analysis, cybersecurity measures, verifications, and completion of the Design History File per FDA requirements. The miniDxR is designed to excel in both sophisticated clinical labs and challenging field environments.
“From its advanced capabilities to its range of customization options, our team designed this reader with the specific needs of point-of-care testing in mind,” said Pat Vaughan, Ph.D., COO of DCN Dx.
Blood Test Predicts Chronic Lung Disease in Preterm Babies
ronchopulmonary dysplasia (BPD) is a condition that impacts 65% of preterm infants, leading to chronic lung disease and neurodevelopmental impairments that persist throughout life. BPD typically arises when premature infants require respiratory support and prolonged oxygen therapy, which can damage their developing lungs. Currently, options for predicting, preventing, and treating BPD are inadequate. Diagnoses are often not confirmed until 36 weeks postmenstrual age, delaying interventions that could reduce lung damage and enhance respiratory health. Existing early prediction tools do not effectively address the underlying pathology of the disease. However, timely lung protective measures can modify BPD incidence. More precise care could be administered if the likelihood of lung damage and other complications in these infants were known sooner. Researchers have now developed a blood test that can predict which preterm infants will go on to develop chronic lung disease, facilitating earlier intervention and more focused treatment strategies.
The research, led by Murdoch Children’s Research Institute (MCRI,
Victoria, Australia; www.mcri.edu.au), found that variations in specific blood proteins, combined with factors like gestational age, birth weight, and sex, can accurately predict BPD within the first 72 hours of life. This study involved testing 493 proteins in the blood of 23 infants born before 29 weeks’ gestation. Notably, alterations in 49 proteins were observed in infants who later exhibited BPD, with some changes detectable within just four hours after birth. The study, published in the American Journal of Respiratory Cell and Molecular, provides a detailed overview of the early biological shifts occurring in infants with BPD, offering critical insights into the disease’s early progression. The researchers are now aiming to develop a comprehensive tool for assessing lung injury, which could be utilized across all preterm infants in Neonatal Intensive Care Units (NICU) or special care nurseries to evaluate the risk of developing BPD.
“The tool, including a blood test, would provide clinicians with the ability to guide respiratory decisions from birth, giving these babies more chances towards a healthy life,” said MCRI’s Dr. Prue Pereira-Fantini.
Image: The miniDxR sets a new standard for customizable lateral flow test readers in clinical and laboratory applications (Photo courtesy of DCN Dx)
Experts to Meet on Trending Topics in Laboratory Medicine
A
t MEDICA (Düsseldorf, Germany; www.medica-tradefair. com), the world’s premier trade fair for the healthcare industry and medical technology sector, this year’s event (November 11–14) will focus on the most exciting medical advancements. Professional forums and their accompanying stage programs will delve into health IT, medical technology trends, healthcare policy, and laboratory medicine. Among the highlights is the MEDICA LABMED FORUM, known for its informative lectures and expert panel discussions, which has become a key feature of the MEDICA program. Around 6,000 companies have secured their spots at MEDICA 2024 and COMPAMED 2024, the concurrent supplier trade fair. Last year, both events together attracted a total of 83,000 visitors.
This year, the focus is on massive digitalization, networking, big data applications, and artificial intelligence (AI), collectively referred to as “Lab 4.0.” On November 11, the opening day of MEDICA 2024, the MEDICA LABMED FORUM will address the hot topic of digitalization and AI. The morning session will concentrate on the shortage of skilled personnel, a pressing issue in laboratory medicine. Panelists will explore how automation and digitalization could help resolve this crisis. The afternoon session will shift to AI and big data tools that are either currently available or in development. Discussions will cover image recognition through deep learning, now standard for automated leucogram analysis, and the developmental state of machine learning for handling the vast multivariate data sets in laboratory diagnostics. A key question will be whether large language models can clarify complex lab findings and whether AI is making us smarter or dumber.
On the second day, discussions will focus on developments in laboratory medicine regarding cardiovascular diseases and cancer, the leading causes of mortality in the Western world. The cardiology section will highlight congenital heart defects, which are increasingly surgically correctable in childhood and are becoming more prominent in adult medicine due to extended life expectancy. Speakers will provide a clinical perspective and demonstrate the potential of machine learning in modern data evaluation. The afternoon session will cover highly sensitive cancer diagnostics using blood, known as “liquid biopsy,” which is revolutionizing oncology by allowing closer monitoring of tumor progression than conventional tissue biopsies. The session will also explore new techniques like analyzing methylation profiles for early detection of hereditary cancer forms and single-cell analysis using microfluidics.
On Young Scientists’ Day, the next generation of researchers will present their perspectives on the future of laboratory medicine, offering insights into the latest advancements and challenges. Topics will include wearables for continuous diagnostic monitoring and the ongoing shortage of skilled personnel. The afternoon will feature discussions on personalized therapy based on individual laboratory parameters, the integration of laboratory and imaging diagnostics, and the role of AI in these fields.
The forum’s final day traditionally focuses on diagnostic research institutes and companies looking to introduce new applications in laboratory medicine. The theme for 2024 will center on aging, with sessions examining pathophysiology, diagnostics, and treatment. Topics will include the genetic and epigenetic factors influencing biological aging, protein misfolding as a basis for neurodegenerative diseases like Alzheimer’s and Parkinson’s, and the role of gut microbiota in strokes. As the forum’s “grand finale,” discussions will address theories and practical approaches to slowing the aging process, such as anti-aging drugs, the effects of anti-inflammatory agents, environmental influences on aging in the central nervous system, and methods for repairing nervous system lesions.
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2024
OCTOBER
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
9th National SIPMeL Congress – Italian Society of Clinical Pathology and Laboratory Medicine. Oct 28-30; Riva del Garda, Italy; congressosipmel2024.it
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
CALILAB 2024 – 7th Argentine Congress of Quality in Clinical Laboratory. Nov 6-8; Buenos Aires, Argentina; calilab.fba.org.ar
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
RBSLM 2024 – Annual Meeting of the Royal Belgian Society for Laboratory Medicine. Nov 14, 15; La Hulpe, Belgium; rbslm.be
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
LABCLIN 2024 – 18th National Congress the Spanish Societies for Clinical Laboratory (AEBM-ML, AEFA & SEQCML). Nov 20-22; Bilbao, Spain; labclin2024.es
AMP 2024 – Annual Meeting & Expo of the Association for Molecular Pathology. Nov 21-23; Vancouver, BC, Canada; amp.org
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
ICID 2024 – 20th International Congress on Infectious Diseases. Dec 3-6; Cape Town, South Africa; Web: isidcongress.org
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
CACLP 2025 – 22nd China International In Vitro Diagnostic Expo. Mar 22-24; Hangzhou, China; en.caclp.com
APRIL
ESCMID Global 2025. Apr 11-15; Vienna, Austria; escmid.org
Korea Lab 2025. 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
Expolab 2025 – 25th Mexican National Congress of Clinical Chemistry and Laboratory Medicine. Apr 30May 3; Monterrey, Mexico; fenacqc.org.mx
MAY
Immunology 2025– Annual Meeting of the American Association of Immunologists (AAI). May 3-7; Honolulu, HI, USA; immunology2025.aai.org
ISTH 2025 Congress – International Society for Laboratory Hematology. May 7-9, Halifax, NS, Canada; islh.org
22nd International Congress of Cytology – International Academy of Cytology. May 11-15; Florence, Italy; cytology-iac.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
LabMedUK25 – National Meeting of the Association for Laboratory Medicine (UK). Jun 9-11; Manchester, UK; labmed.org.uk
FIME 2025 – 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 Association. Jun 12-15; Milan, Italy; ehaweb.org
EAACI Congress 2025 – European Academy of Allergy & Clinical Immunology. Jun 13-16; Glasgow, UK; eaaci.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
MedLab Asia 2025. Jul 16-18; Kuala Lumpur, Malaysia; medlabasia.com
IUIS 2025 – 19th International Congress of Immunology. Aug 17-22; Vienna, Austria; iuis.org SEPTEMBER
Thailand LAB International 2025. Sep 3-5; Bangkok, Thailand; thailandlab.com
ECP 2025 – 36th Congress of the European Society of Pathology. Sep 6-10; Vienna, Austria; esp-pathology.org
CAP25 – Annual Meeting of the College of American Pathologists. Sep 13-16; Orlando, FL, USA; cap.org
MASCL 2025 – Congress of the Association for Mass Spectrometry & Advances in Clinical Lab. Sep 21-26; Montreal, Canada; msacl.org OCTOBER
DKLM 2025 – Annual Congress of the German Society
for Clinical Medicine and Laboratory Medicine (DGKL). Oct 24-25; Leipzig, Germany; laboratoriumsmedizinkongress.de
WSPID 2025 – 14th World Congress of the World Society for Pediatric Infectious Disease. Oct 28-31; Bangkok, Thailand; wspid2025.com
LMCE-KSLM 2025 – Laboratory Medicine Congress & Exhibition and 66th Annual Meeting of the Korean Society of Laboratory Medicine. Oct 29-31; Incheon, Korea; lmce-kslm.org
NOVEMBER
APCCMI 2025 – 20th Asia Pacific Congress of Clinical Microbiology and Infection. Nov 2-4; Bangkok, Thailand; apccmi2025.com
65th Annual Academic Assembly of the Japan Society of Clinical Chemistry (JSCC). Nov 7-9; Nagoya, Japan; jscc-jp.gr.jp
AMP 2025 – Annual Meeting & Expo of the Association for Molecular Pathology. Nov 11-15; Boston, MA, USA; amp.org
MEDICA 2025. Nov 17-20; Dusseldorf, Germany; medica-tradefair.com
From harnessing AI to nanotechnology to diagnostic discovery and beyond, the world of laboratory medicine is captivating. Your work has the power to energize and inspire awe in the global community at ADLM 2025 (formerly AACC Annual Scientific Meeting) in Chicago next July.
Ready to bring us your best?
Submit your proposal for the ADLM 2025 edition of Roundtables, ADLM University, and the core of the meeting, Scientific Sessions.
Visit meeting.myadlm.org for a complete list of submission guidelines and session categories. Deadline for submissions is November 7, 2024.
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