Sepsis, a critical emergency condition, results from an overactive inflammatory response to pathogens like bacteria or fungi in the blood, leading to organ damage and the possibility of sudden death. It holds a 30day mortality rate of over 30%,
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Rapid Method for Determining Virus Infectivity Can Revolutionize Response to Future Pandemics
On average, every four years a new virus emerges that poses a pandemic threat, in addition to numerous already known viruses that have the potential to jump across species. Currently, there is no test that can quickly determine whether a virus in a sample is
ADLM 2024 Roundup: Innovations Shaping the Future of
Clinical Diagnostics
The world’s largest in vitro diagnostics meeting was held on July 28-August 1 in Chicago. LabMedica’s editors review highlights of the technical exhibition, showcasing latest innovations in the field.
intact and potentially infectious, or damaged and non-infectious, without requiring weeks of cell culture. The traditional method for assessing viral infectivity involves the use of cultured cells, which not only takes days to yield results but also requires special-
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Portable Device Monitors Cancer Patient Health
Chemotherapy and similar treatments aimed at eliminating cancer cells often adversely affect patients’ immune cells. Each year, this results in tens of thousands of cancer patients suffering from weakened immune systems, making them susceptible to potentially fatal infections. Physicians are tasked
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MSignatures in Blood Can Predict Risk of Over 60 Diseases
easuring specific proteins to diagnose conditions like heart attacks, where troponin is tested, is a well-established clinical practice. Now, new research highlights the broader potential of protein measurements from a small blood sample to predict a
variety of diseases.
In the research, published in Nature Medicine, which was carried out as part of an international partnership involving Queen Mary University of London (London, UK; www.qmul.ac.uk), the investigators used data from the
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POC Detection of Stroke within Minutes
Each year, more than 20 million people worldwide suffer from strokes. Large vessel occlusions (LVO) constitute 30% of these cases but are behind 95% of the resulting disabilities and fatalities. The likelihood of recovery improves significantly if a procedure known as ‘thrombectomy’ is performed immediately after the onset of symptoms. However, speeding up this treatment is
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Test Predicts Organ Transplant Outcomes
In a landmark study, an interdisciplinary research team from the Westmead Institute for Medical Research (WIMR, NSW, Australia; www.westmead institute.org.au) and the University of Sydney (NSW, Australia; www.sydney.edu.au) has identified, for the first time, common molecular biomarkers for transplant rejection across major transplanted organs, including hearts,
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Sepsis Testing Reduced From Days to Hours
Cont’d from cover which is more than double that of heart attacks. Prompt administration of the correct antibiotic is vital for reducing this high mortality rate. To determine the best treatment, three independent tests are typically required: blood culture to confirm the infection, pathogen identification to pinpoint the specific infecting organism, and antimicrobial susceptibility testing (AST) to identify the most effective antibiotic. Currently, obtaining AST results, which are crucial for selecting the appropriate antibiotic, can take more than 2-3 days. Delays in these results contribute to inappropriate antibiotic use, accelerating the emergence of multidrug-resistant ‘superbugs.’ While advancements have shortened the
timeframe needed for AST, no global progress has been made in reducing the time required for the blood culture process, which is the most time-consuming. Now, an ultra-rapid AST method that bypasses the need for traditional blood culture has demonstrated the potential to reduce the turnaround time of reporting drug susceptibility profiles by more than 40–60 hours compared with hospital AST workflows.
The ultra-Rapid Antimicrobial Susceptibility Testing (uRAST) developed by researchers from the Department of Electrical and Computer Engineering at Seoul National University (Seoul, Korea; https://ece.snu.ac.kr), in collaboration with QuantaMatrix Inc. (Seoul, Korea; www. quantamatrix.com), is the world’s first to bypass the lengthy blood culture phase, allowing for the completion of all necessary tests for an effective antibiotic regimen within a single day. The uRAST technology employs nanoparticles coated with immune proteins that specifically bind to pathogens, enabling the direct isolation of these pathogens from a patient’s blood. The researchers have also integrated new technologies that rapidly conduct pathogen identification and AST, considerably speeding up the testing process. In a clinical trial involving 190 patients suspected of having sepsis, uRAST delivered complete test results within just 13 hours, slashing 40-60 hours off the time required by traditional diagnostic methods. Moreover, uRAST achieved accuracy levels that meet FDA standards.
Another significant aspect of this research published on July 25th in Nature is the integration of fully automated technology that consolidates all necessary sepsis diagnostics into one streamlined process. Traditionally, each test is performed separately and manually, causing delays—particularly outside of normal laboratory operating hours. For instance, if a blood culture is completed after-hours, further testing must wait until the next day, thus missing the critical window for effective sepsis intervention. This research demonstrated the potential for continuous, 24/7 diagnostic operations by automating the entire sequence of necessary tests for sepsis, significantly improving the prospects for timely patient care.
ADLM 2024 Roundup: Innovations Shaping the Future of Clinical Diagnostics
The Association for Diagnostics & Laboratory Medicine (ADLM, Washington, DC, USA; www. myadlm.org) hosted the ADLM 2024 Clinical Lab Expo (formerly AACC Annual Scientific Meeting & Clinical Lab Expo) in Chicago on July 28–August 1, featuring latest advances in diagnostic research and technology and accentuating the essential role laboratory medicine plays in healthcare.
ADLM Clinical Lab Expo is currently the world’s largest laboratory medicine exposition, showcasing innovations shaping the future of clinical testing and patient care. ADLM brings together more than 70,000 clinical laboratory professionals, medical specialists, research scientists, and industry executives from around the world, focused on clinical chemistry, molecular diagnostics, mass spectrometry, translational medicine, lab management, and other growing areas of biomedical sciences.
This year, 18,000 laboratory medicine professionals registered for ADLM 2024, a 6% increase in attendance over the last ADLM Annual Meeting in Chicago in 2022. The ADLM 2024 Clinical Lab Expo boasted nearly 900 exhibitors and covered over 270,000 sq. ft. (25,000 sq. m.) of net exhibition space. The exhibition featured cutting-edge tests from all laboratory medicine disciplines, including artificial intelligence, molecular diagnostics, automation, point-ofcare testing, mass spectrometry, and mobile health. Additionally, ADLM 2024 brought together scientists and specialists from around the world for an immersive experience featuring 5 plenaries, around 70 scientific sessions, more than 170 roundtables, and over 700 posters.
One highlight of the meeting was a special session where representatives from ADLM, the American Medical Association, and the Children’s Hospital Association detailed how the FDA’s new rule placing laboratory developed tests under FDA oversight could adversely impact healthcare. The session featured a caregiver and patient advocate who
shared her perspective on why laboratory developed tests are crucial to timely diagnosis and treatment.
As part of ADLM’s Disruptive Technology Award competition, biomedical innovators presented novel technologies that could help more patients get accurate diagnoses. Mercy BioAnalytics (Natick, MA, USA; www. mercybio.com) won the competition with its liquid biopsy platform that detects ovarian cancer in its earliest stages by measuring tumor-derived extracellular vesicles.
Abbott (Abbott Park, IL, USA; www. abbott.com) demonstrated the Alinity ci-series of integrated clinical chemistry & immunoassay systems offering powerful integration across clinical chemistry and immunoassay. These systems can easily scale, combining up to four modules in multiple configurations to meet any laboratory's needs and maximize its operational efficiency. Abbott also highlighted the Alinity h-series integrated hematology systems which deliver simplified workflows through an innovative design to streamline the hematology laboratory. Also featured was Abbott’s award-winning i-STAT Alinity POC system designed to be easy, accurate and connected, providing results in minutes and integrating diagnostic patient-testing directly into the clinical-care pathway.
Beckman Coulter (Brea, CA, USA; www.beckmancoulter.com) highlighted the small yet sophisticated DxH 500 hematology analyzer that delivers a high-quality CBC and full 5-part differential with only 12 μL of blood. Also featured was the DxH 900 hematology analyzer that delivers accurate and high-confidence results on the first run alongside the DxH Slidemaker Stainer II (SMS II) which prepares slides automatically based on orders received from the LIS. Additionally, Beckman Coulter featured the DxI 9000 high-throughput, high-sensitivity immunoassay analyzer that is designed to power lab performance across health systems. Among its innovations in biomarkers, Beckman Coulter showcased Monocyte Distribution Width
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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
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(MDW), the only regulatory-cleared hematological biomarker that helps to establish risk of severe infection and sepsis in adult patients in the emergency department.
Bio-Rad (Hercules, CA, USA; www.bio-rad.com) showcased an array of quality control(QC)-related offerings and also presented a workshop on adapting lab practices to new CLIA 2024 specifications. BioRad’s booth on the exhibition floor offered an assortment of displays and demonstrations of its leading QC products, such as infectious disease molecular controls & standards; the family of InteliQ load-and-go controls; and Unity Next Peer QC data management solutions. Bio-Rad also highlighted its Exact Diagnostics line of molecular standards and controls for the testing of pathogens in the areas of transplant, respiratory, virology, microbiology, hospital-acquired infections, sexually transmitted infections, and vector-borne diseases.
Chronus Health (Fremont, CA, USA; showcased the world’s first real-time electrical blood test system for use in urgent care centers, skilled nursing facilities, infusion centers, retail clinics, as well as primary care and specialty clinics. This technology will reduce time to diagnosis and lower overall healthcare costs since blood samples are analyzed on-site rather than sent to central labs for analysis. Chronus’ platform can uniquely sup port cell counting, chemistry assays (electrolytes, small molecules, and proteins), and immunoassays (pro teins).
Cytovale (South San Francisco, CA, USA; www.cytovale.com ted its FDA-cleared IntelliSep sep sis test, which processes samples in around 8 minutes. Visitors to the Cytovale booth also saw the Cytovale System in action. The Cytovale System interrogates thousands of cells per second to rapidly assess host immune state and identify disease signatures. A simple workflow with minimal hands-on time provides clinicians with actionable information in under 10 minutes to aid in diagnosis and inform treatment. With cutting-edge host response technology, the IntelliSep sepsis test along with the Cytovale System provides laboratory professionals with sepsis risk stratification results in ~8 minutes, enabling teams in the Emergency Department (ED) to make timely, life-saving decisions.
New flexible and fully automated solution
Fast and easy pre-analytical protocol, no centrifugation needed
• Method based upon antigen capture using monoclonal antibodies
• Individual quality control per monotest, no need for additional controls or calibrations.
• Objective method with excellent diagnostic sensitivity and specificity.
EKF Diagnostics (Cardiff, Wales, UK; www.ekfdiagnostics.com) highlighted the Quo-Lab HbA1c semi-automated desktop POC analyzer for mea-
Vircell Anuncio LABMEDICA 140x185 HPYLORI AG VIRCLIA_EN.pdf
ADLM 2024 Roundup
URINE ANALYZER DIRUI INDUSTRIAL
The H-1600 urine analyzer has a throughput of up to 240 tests/hour and can test for 14 parameters. It features a user-friendly large LCD touchscreen and can be integrated with the FUS-360 unit for a urinaly-
C-Line, an advanced version of its industry leading rapid benchtop glucose and lactate analyzer. Within its portfolio of hematology POC devices, EKF highlighted the DiaSpect Tm hand-held hemoglobin analyzer which is now powered by EKF Link, enabling new functions like hematocrit calculation, quality control management and patient data management functions.
HemoSonics (Durham, NC, USA; www.hemosonics.com) demonstrated its Quantra Hemostasis System which has the broadest range of FDA-cleared indications for use in its category and is cleared for use with arterial and venous blood samples in cardiac, trauma, liver, and major orthopedic surgery patients. HemoSonics' Quantra Hemostasis System consists of the Quantra Hemostasis Analyzer with QPlus and QStat Cartridges, which enable clinicians to deliver patient-centered decisions on bleeding management that improve care and optimize blood product usage. The Quantra System is FDA-cleared for use in point-of-care settings such as operating rooms, intensive care units, and in hospital laboratories, enabling hospitals to standardize use institution-wide with greater operational efficiency.
HORIBA (Kyoto, Japan; www.horiba.com) showcased its newly-launched compact hematology analyzers with combined Erythrocyte Sedimentation Rate (ESR) and complete blood count (CBC)/differential (Diff). HORIBA presented the new Yumizen H550E (autoloader), H500E CT (closed tube), and Yumizen H500E OT (open tube) which now offer combined testing for CBC/DIFF with ESR results from whole blood in 60 seconds. Also featured was the new Yumizen C230 benchtop chemistry analyzer for small-volume laboratories with advanced
HEMATOLOGY ANALYZER EDAN INSTRUMENTS
The H 80 hematology analyzer is designed to lighten the workload associated with hematology analysis and streamline workflow, ensuring efficient and accurate results for every blood sample.
and user-friendly features. In addition, HORIBA showcased the new Yumizen C240 chemistry analyzer which is designed with system simplicity for expedient and efficient performance.
Inpeco (Novazzano, Switzerland; www.inpeco.com) introduced FlexLab X, its new total lab automation system, to the global laboratory medicine community. Open and flexible by design, FlexLab X allows labs to freely combine analyzers from different vendors, for optimal patient outcomes. FlexLab X assures rapid and consistent turnaround times (TAT) at all sample volume levels, and it supports premium-quality results that are fully traceable. Moreover, FlexLab X is designed to maximize uptime and reduce running costs, contributing to an attractive return on investment (ROI). Offering sleek graphical user interfaces (GUI) and powerful Data Analytics functionalities, FlexLab X is intuitively easy to use and monitor. This simplifies daily work and helps eliminate errors, while KPI dashboards provide actionable insights to streamline workflows.
Messe Düsseldorf (Düsseldorf, Germany; www.messe-duessel dorf.de) promoted its “MEDICAlliance” program of regional and international medical trade fairs organized around the globe. At ADLM 2024, visitor and exhibitor information were available for MEDICA 2024 – World Forum for Medicine, and COMPAMED 2024 – High Tech Solutions for Medical Technology (held currently on November 11-14, 2024 in Düsseldorf, Germany), Medical Fair China (August 2024 in Suzhou), Medical Fair Asia and Medical Manufacturing Asia (held concurrently on September 2024 in Singapore) as well as Medical Fair Thailand (September 2025 in Bangkok) and Medical Fair India (2025 in New Delhi).
OnsiteGene (San Diego, CA, USA; www.onsitegene.com) introduced the new XDive, the world's first 5-minute real-time PCR instrument. This groundbreaking innovation completes 40 thermal cycles
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and real-time fluorescent imaging in just five minutes while maintaining sensitivity comparable to leading brands on the market. XDive integrates high-speed thermal cycling, ultra-fast PCR reaction reagents, and real-time fluorescence data acquisition workflows. It can perform up to 16 ultra-fast reactions per experiment, providing moderate sample throughput and maximum working flexibility.
QuidelOrtho (San Diego, CA, USA; www.quidelortho.com) provided onsite demonstrations of its diverse product lines including Vitros automation solutions which can reduce manual steps, increase efficiency and free up lab staff to focus on the delivery of quality results while reducing operational costs. QuidelOrtho demonstrated the Vitros XT 7600 system which offers a full clinical chemistry and immunoassay menu in one easy-to-use system that delivers industry-leading uptime. Visitors to QuidelOrtho’s booth also experienced the Vitros XT 3400 Chemistry System which is powered by intelligent technologies and digital imaging technology to help labs meet routine testing needs, with proven high-quality results and system reliability in a small footprint.
Randox (Crumlin, UK; www.randox.com) highlighted its recently
released Acusera SMART controls range consisting of Smartscan and Smartload products which have been designed to fit directly onto a wide range of test systems. This range further streamlines the QC process, without the need to aliquot material, minimizing human error and optimizing workflows. Additionally, Randox highlighted its new Acusera Quality Controls, including active B12, serum indices, and ultra-low PSA. Randox’s booth also featured comprehensive panels on the company’s MultiStat fully automated immunoanalyzer, now expanded to include gastrointestinal diseases, bladder cancer, and male and female hormones.
Roche (Basel, Switzerland; www. roche.com) featured its newest innovations in-booth, including the future cobas Mass Spec solution designed to be a total end-to-end solution for clinical mass spectrometry testing with the goal of seamless integration into the routine laboratory. Roche also highlighted the new CCM Vertical, a flexible modular system that uses lab space effectively and seamlessly integrates into the existing cobas connection modules. Also featured was the cobas liat system which brings gold-standard PCR technology to the point of care, providing results within 20 minutes across a growing menu of assays.
Siemens Healthineers (Forchheim, Germany; www.siemens-healthineers. com) presented enhancements to its
• Assessment of all clinically significant bile acids in serum and stool
• Reliable monitoring of liver function and assessment of intestinal health
• Outstanding precision and stability
• Wide measuring range for both diagnostic applications
AUTOMATED ELISA SYSTEM
EUROIMMUN
The EUROIMMUN Analyzer I is an open system for fully automated ELISA processing of up to 7 microplates and 180 patient samples in one run. Use of EUROIMMUN ELISAs with EUROIMMUN Analyzer I enables quick and secure routine operation.
Atellica portfolio that underscore sustainability, leading workflow efficiency, AI-enabled intelligence, and advanced analytics to turn data into practical clinical insights. Siemens consolidates 25 tasks directly into the Atellica systems. Chip, sensors, and lines of code work together to help simplify tasks and minimize hands-on time. In minutes, a single technologist can manage calibration and QC, daily sorting, and archiving processes—tasks that historically may have taken hours—to improve throughput and reduce waste.
Sysmex (Kobe, Japan; www.sysmex.com) showcased its innovative portfolio of hemostasis analyzers and reagents, including the CS-2500 advanced hemostasis solution that is compact, low maintenance, and can seamlessly handle sample loading and off-loading for high throughput. Sysmex also featured the cutting-edge XN-9100 automated hematology system which is a modular analyzer system that provides accuracy, reliability, and efficiency. Visitors to Sysmex’s booth experienced the UN-3000 automated urinalysis solution with the TH-11 urine sample decapper unit. Among its informatics solutions, Sysmex presented the Caresphere Workflow Solution (WS) which is designed to address data privacy, security, and compliance concerns, delivering dramatic workflow efficiency increases to laboratories.
Thermo Fisher Scientific (Waltham, MA; USA; www. thermofisher.com) showcased its broad diagnostics portfolio and hosted a series of customer-led workshops and presentations that highlighted industry developments as well as the company’s latest innovations. The company’s conference booth was designed as a “Story Tunnel” to lead visitors along a journey of research and clinical solutions impacting patient care across oncology, infectious disease, women’s health, toxicology, allergy and autoimmune
HEMOSTASIS SYSTEM
SIEMENS HEALTHINEERS
The CS-5100 hemostasis system is a random-access, high-volume coagulation analyzer that enables labs to achieve high-quality results on the first test run by identifying and managing unsuitable test specimens before analysis.
diseases, and transplant and protein diagnostics. Thermo Fisher also demonstrated the Optilite Analyzer, along with providing an overview of the Freelite assays, which received 510(k) clearance from the U.S. Food & Drug Administration (FDA) to evaluate monoclonal gammopathy of undetermined significance (MGUS), a precursor to multiple myeloma.
Tianlong Science and Technology (Shaanxi, China; www. tlgenetech.cn) featured the Gentier X3 Series Real-Time PCR System which has a high throughput of up to 96 tests per hour and provides the excellent function of running maximum 3×32-well samples in three different protocols on three independent thermal blocks simultaneously. Tianlong demonstrated the Biolum Portable ATP Hygiene Monitoring System Pro which generates results in just 10 seconds, with sensitivity of up to 10-16 mol of ATP. Tianlong also demonstrated the Panall 8000 all-in-one molecular diagnosis system which integrates the features of sample tube decapping/capping, sample loading, nucleic acid extraction, PCR setup, PCR detection, and result analysis, achieving a true sample-in-result-out detection process. Tianlong’s Panall 8000 is now OPEN to be compatible with PCR reagents from different manufacturers.
Werfen (Barcelona, Spain; www.werfen.com) introduced the GEM Premier 7000 with Intelligent Quality Management 3 (iQM3), a breakthrough in blood gas testing that detects hemolysis at the POC. The GEM Premier 7000 with iQM3 is a portable critical care system for use by health care professionals to rapidly analyze lithium heparinized whole blood samples at the point of health care delivery in a clinical setting and a central laboratory. Werfen also provided a virtual reality laboratory experience to visitors at its booth where they could see 3D customized layouts of HemoCell specialized lab automation workcells for hemostasis labs of all sizes, shapes, and volumes.
The ADLM Annual Meeting & Clinical Lab Expo 2025 will take place on July 27-31, 2025 in Chicago, IL, USA.
ADLM 2024 Roundup
Open Chemiluminescence Immunoassay Analyzer
GASTROINTESTINAL INFECTION TEST AB ANALITICA
The REALQUALITY Gastro-P is an IVD for identification of Cryptosporidium, Giardia lamblia, and/or Entamoeba histolytica. The assay requires only 5 µL of extracted DNA and its automatic format can be used on GENEQUALITY platform.
AUTOMATIC CLINICAL CHEMISTRY ANALYZER URITEST MEDICAL ELECTRONIC
The CA – 640A automatic clinical chemistry analyzer has a constant throughput of 60T/H and 890T/H with ISE. Featuring a user-friendly interface, the highly reliable system requires minimal intervention demands.
POC Detection of Stroke within Minutes
complicated because it’s difficult to identify LVO strokes outside hospital settings; symptoms can mimic other medical issues. Strokes can also result from blockages in smaller vessels or vessel ruptures, neither of which are suitable for thrombectomy. Ideally, LVO strokes need to be diagnosed quickly and before the patient arrives at the hospital to speed up the initiation of thrombectomy. Currently, there is no sufficiently accurate diagnostic tool for this purpose. Now, a groundbreaking diagnostic test can identify an LVO stroke within 15 minutes, expediting patient transfer to specialized care and saving more than 1 hour 30 minutes over the current clinical pathway.
The innovative LVOne test from UpFront Diagnostics (Cambridge, UK; upfrontdiagnostics.com) employs a combination of blood-based biomarkers and clinical scoring to accurately detect patients undergoing an LVO stroke. The Testing for Identification Markers of strokE (TIME) clinical study has confirmed the efficacy of UpFront’s specific blood biomarkers GFAP and D-dimer, achieving 90% accuracy in identifying LVO strokes. This prospective, observational diagnostic accuracy study analyzed data from 323 patients suspected of stroke. It demonstrated that integrating GFAP and D-dimer biomarker levels with FAST-ED scores within six hours of symptom onset allows the LVOne test to achieve 93% specificity and 81% sensitivity in detecting LVO strokes. The test also successfully excluded all patients with brain hemorrhages, suggesting potential future applications in identifying intracerebral hemorrhages in the field.
Published in the open-access journal Stroke: Vascular and Interventional Neurology, these outstanding results build on previous UK clinical trials by UpFront Diagnostics, paving the way for pre-hospital identification of LVO stroke patients. Implementing this biomarker strategy in the field could significantly reduce the time to thrombectomy, lower disability risks, and the associated medical and social costs of strokes. Moreover, GFAP and D-dimer have emerged as leading biomarkers for LVO stroke detection in pre-hospital settings. The LVOne test holds great promise for future deployment in low- and middle-income countries where advanced imaging technologies may be unavailable. It might also find use in evaluating traumatic brain injuries. Future studies will test the LVOne device’s efficacy in ambulances and an interventional trial will explore its potential to streamline stroke patient triage by bypassing conventional imaging and proceeding directly to therapeutic interventions.
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AI Integrated With Optical Imaging Enables Rapid Intraoperative Diagnosis
Rapid and accurate intraoperative diagnosis is essential for tumor surgery as it guides surgical decisions with precision. Traditional intraoperative assessments, such as frozen sections based on H&E histology, are demanding in terms of time, resources, and labor and also raise concerns about specimen consumption. D-FFOCT, a high-resolution optical imaging technology, allows for the quick generation of virtual histology. Researchers have now developed an intraoperative diagnostic workflow that uses deep learning algorithms to classify tumors from D-FFOCT images, offering rapid and automated diagnosis for surgical decision-making.
A prospective cohort study conducted by researchers from Peking University People’s Hospital (Beijing, China; www.pkuph.cn) included 224 breast samples imaged using D-FFOCT. This imaging technique is non-destructive and requires no tissue preparation or staining. The D-FFOCT images were segmented into patches, and slides were allocated into a training set (182 slides, 10,357 patches) and an external testing set (42 slides, 3,140 patches) based on the order in which they were collected. A five-fold cross-validation method was employed to train and fine-tune
the model. A machine learning model aggregated the patch prediction results to the slide level after feature extraction.
The testing set showed the model performed well at the patch level, identifying breast tissue types with an AUC of 0.926 (95% CI: 0.907–0.943). At the slide level, the diagnostic accuracy reached 97.62%, with a sensitivity of 96.88% and a specificity of 100%. Accuracy did not significantly differ across various molecular subtypes and histologic tumor types of breast cancer. Visualization heatmaps demonstrated that the deep learning models could identify features corresponding to metabolically active cell clusters in D-FFOCT images, aligning with expert assessments. This image analysis approach could potentially extend to various tumor types, given the conserved features detected in the model. In a margin simulation experiment, the diagnosis process took about three minutes, with the deep learning model achieving a high accuracy of 95.24%.
Based on the results, the study has proposed an intraoperative cancer diagnosis workflow integrating D-FFOCT with a deep learning model. In simulated intraoperative margin diagnosis, the workflow substantially reduced diagnosis time by about tenfold compared to traditional
Low-Cost CRISPR-Based Paper Strip Test to Improve Flu Diagnosis and Monitoring
Annually, less than 1% of people who contract the flu are tested, largely due to the need for skilled personnel and sophisticated equipment. Now, researchers have developed a low-cost paper strip test that could enable more individuals to determine the type of flu they have and receive appropriate treatment. This innovative test developed by researchers from the Broad Institute of MIT and Harvard (Cambridge, MA, USA; www.broadinstitute. org) and Princeton University (Princeton, NJ, USA; cbe.princeton.edu) employs CRISPR technology to differentiate between the primary seasonal flu types, influenza A and B, and the subtypes H1N1 and H3N2. It can also identify strains resistant to antiviral treatments and could potentially extend to detecting swine and avian flu strains, including H5N1, which currently affects cattle. This could enhance both outbreak response and clinical care by making accurate, affordable, and rapid testing accessible in doctors’ offices and laboratories across the world. The test is based on a technology known as SHINE, developed by the team in 2020, which uses CRISPR enzymes to identify specific viral RNA sequences in samples. Initially applied to detect SARS-CoV-2 and its variants Delta and Omicron, the technology was adapted in 2022 to screen for widespread viruses like the flu, aiming for use in field or clinic settings outside traditional hospital or diagnostic lab environments.
methods and proved to be highly cost-effective in terms of labor. No tissue was destroyed during optical imaging and analysis. Overall, this workflow offers a transparent solution for rapid and accurate intraoperative diagnosis, potentially guiding surgical decisions effectively.
1 Drop 1 Minute
Traditional diagnostic methods like polymerase chain reaction (PCR) involve long processing times, specialized training and equipment, and the need for deep freeze storage for reagents. In contrast, the SHINE assay operates at room temperature and completes in about 90 minutes. The only equipment required currently is an affordable heat block to heat the reactions, and efforts are underway to reduce the result time to 15 minutes. The researchers have also fine-tuned SHINE to differentiate between various flu strains and suggest it might later be adjusted to identify different viruses with similar symptoms, such as influenza and SARS-CoV-2. This capability could aid clinicians in deciding whether to administer treatments like Oseltamivir, which is only effective against certain flu strains. In outbreak scenarios, rapid testing could also enable more targeted sample collection to better track virus spread. Moving forward, the team plans to further adapt SHINE for detecting both avian and swine influenza strains.
“Ultimately, we hope these tests will be as simple as rapid antigen tests, and they’ll still have the specificity and performance of a nucleic acid test that would normally be done in a laboratory setting,” said Cameron Myhrvold, assistant professor at Princeton University and co-senior author on the study, which was published in The Journal of Molecular Diagnostics on June 18, 2024.
ABSOL HS is a high-sensitivity ELISA analyzer for early screening and diagnosis of Alzheimer’s and cardiovascular diseases, including mild cognitive impairment. It can also detect Femtogram level molecules with PIFA technology.
Test Predicts Organ Transplant Outcomes
lungs, livers, and kidneys. Their findings suggest that the molecular pathways involved in organ rejection are consistent across these different solid organs. This breakthrough is crucial as it enables the development of strategies aimed at improving the success rates of all types of organ transplants by utilizing machine learning to predict transplant outcomes with remarkable accuracy.
In a collaborative effort, the researchers created the Pan-organ ResOurce for Molecular Allograft Dysfunction (PROMAD), a comprehensive molecular atlas that includes over 12,000 patient samples from across the world. This atlas allows broader access to transplant data that was previously unavailable to many researchers, fostering international cooperation. The creation of this atlas has led to the development of a proof of concept for a universal blood test that can predict the possibility of transplant rejection before it happens, potentially redefining standards in precision medicine and enhancing transplant outcomes globally.
The team is currently advancing this research by trialing a blood test in laboratory settings that could enable physicians to predict and prevent organ rejection. Moreover, their findings provide a foundation for applying these insights to other types of transplantation and different medical conditions. The encouraging outcomes of this research not only highlight the power of international collaboration but also offer new
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The VITEK® REVEAL™ offers rapid antimicrobial susceptibility testing (AST) results to effectively and efficiently manage bloodstream infections. It offers extensive antimicrobial coverage for gram-negative bloodstream infections.
hope to millions awaiting life-saving transplants. Moving forward, the research will expand these discoveries to additional transplant types and further improve the predictive models used in the study.
“This study is a perfect example of how precision medicine can significantly impact clinical practices by integrating global data to benefit individual patients,” said Professor Natasha Rogers, Deputy Director of WIMR’s Centre for Transplant and Renal Research, and a senior author on the study. The findings of the study were published in Nature Medicine on June 18, 2024.
Protein Signatures in Blood Can Predict Risk of Over 60 Diseases
UK Biobank Pharma Proteomics Project (UKB-PPP). This project represents the largest proteomic study to date, analyzing around 3,000 plasma proteins from over 40,000 randomly selected UK Biobank participants. These protein measurements are linked to detailed electronic health records. The researchers applied sophisticated analytical techniques to identify a specific ‘signature’ of 5 to 20 key proteins for predicting each disease. They discovered that these protein ‘signatures’ can predict the onset of 67 different diseases, including multiple myeloma, non-Hodgkin lymphoma, motor neuron disease, pulmonary fibrosis, and dilated cardiomyopathy.
The study found that protein prediction models outperformed the ones based on standard clinical information such as blood cell counts, cholesterol levels, kidney function, and diabetes indicators (glycated hemoglobin). While the benefits of measuring and discussing cardiovascular risks are well known, this research introduces new predictive possibilities for a broad spectrum of diseases, particularly rarer ones that often require prolonged periods to diagnose. These insights could lead to significantly faster and more timely diagnoses. However, these findings
still need to be validated across different populations, including symptomatic and asymptomatic individuals, and across various ethnic groups.
“Several of our protein signatures performed similar or even better than proteins already trialed for their potential as screening tests, such a prostate-specific antigen for prostate cancer,” said Dr. Julia Carrasco Zanini Sanchez, first author and research student at GSK and the University of Cambridge at the time and now a postdoctoral researcher at PHURI. “We are therefore extremely excited about the opportunities that our protein signatures may have for earlier detection and ultimately improved prognosis for many diseases, including severe conditions such as multiple myeloma and idiopathic pulmonary fibrosis. We identified so many promising examples, the next step is to select high priority diseases and evaluate their proteomic prediction in a clinical setting.”
Portable Device Monitors Cancer Patient Health
Cont’d from cover
with balancing the dosage of chemotherapy—enough to kill cancer cells but not so much as to dangerously reduce the patient’s white blood cell count, leading to neutropenia. This condition not only impacts health but can also lead to social isolation between chemotherapy sessions. Traditionally, monitoring of white blood cells has been limited to blood tests. Now, a new at-home white blood cell monitor offers doctors the ability to remotely monitor their patients’ health more comprehensively. This device, which avoids blood draws, uses light to scan the skin at the top of the fingernail and employs artificial intelligence (AI) to identify critically low levels of white blood cells.
Based on technology first conceived by researchers at MIT (Cambridge, MA, USA; www.leuko. com) in 2015, Leuko Labs (Boston, MA, USA; www.web.mit.edu) developed the device which has successfully enabled the detection of low white blood cell counts in hundreds of cancer patients without the need for blood withdrawal. Leuko’s device utilizes imaging technology focused on the capillaries just above the fingernail—a site already used by doctors to evaluate vascular health—to monitor white blood cell activity. In a 2019 study involving 44 patients, Leuko demonstrated its device’s capability to detect critically low white blood cell levels with minimal false positives. The product has since been advanced to a stage where it can be used by patients at home without supervision, providing vital immune system information directly to healthcare professionals.
Over the past four years, Leuko has collaborated with the Food and Drug Administration (FDA) to design studies that confirm the device’s accuracy and ease of use by patients without medical training. Later this year, the company plans to initiate a pivotal study that will support its application for FDA approval. Once approved, Leuko anticipates that the device will not only become a standard tool for patient monitoring but will also assist doctors in optimizing cancer treatment regimens. The company’s founders expect their innovation to enhance care decisions and potentially extend its use to monitoring other health conditions. Furthermore, they envision future adaptations of the device to track additional biomarkers present in the blood.
“The long-term vision for the
company is making this available to other patient populations that can also benefit from increased monitoring of their immune system. That includes patients with multiple sclerosis, autoimmune diseases, organ transplants, and patients that are rushed into the emergency room,” said Leuko co-founder and CEO Carlos CastroGonzalez, a former postdoc at MIT. “We believe this could be a platform technology. We get these noninvasive videos of the blood flowing through the capillaries, so part of the vision for the company is measuring other parameters in the blood beyond white blood cells, including hemoglobin, red blood cells, and platelets. That’s all part of our roadmap for the future.”
Image: The finger-based test takes a minute to noninvasively capture enough information to evaluate white cell levels (Photo courtesy of Leuko Labs)
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Test Detects Blood Cancer Recurrence a Year Earlier
Multiple myeloma, also known as Kahler's disease, is a type of blood cancer originating in the bone marrow characterized by the uncontrolled proliferation of plasma cells, a specific type of white blood cell. Remarkably, half of the patients initially respond to treatment to a degree where the disease becomes undetectable in their blood, but unfortunately, the disease almost invariably returns. Currently, to monitor for the return of the disease, the standard practice involves a bone marrow biopsy, an invasive procedure that is not feasible to perform frequently. This method's reliability can also vary since the disease may not be uniformly distributed across the bone marrow. Alternatively, a less sensitive blood test is available, but it only detects the disease's return when the cancer cell count is considerably elevated. Now, researchers have developed a new blood test that can detect the return of multiple myeloma a full year earlier than the current standard blood test.
This advanced blood test, developed by scientists at Radboud University Medical Center (Nijmegen, the Netherlands; www. radboudumc.nl ) in collaboration with Erasmus MC (Rotterdam, Netherlands; www.erasmusmc.nl), is a thousand times more sensitive than the currently used blood test. It works by measuring antibodies produced by plasma cells, which are crucial to immune defense. Normally, a variety of plasma cells produce antibodies to combat different pathogens, but in multiple myeloma, one plasma cell type multiplies excessively, producing numerous identical plasma cells and antibodies, which the new test targets. Initially, customizing the test for individual patients required 125 days, but researchers have now refined the process to accommodate any patient and simultaneously test 25 patients, reducing the development
time to just five days.
Moreover, the team has developed new software that enhances the measurement process, enabling even faster detection of tumor cell signals. In a trial involving forty patients, this test proved capable of detecting increases in cancer cells a year earlier than the standard blood test. The procedure needs less than a drop of blood, making it minimally invasive. Researchers are also exploring the possibility of patients performing the blood collection at home via a simple finger prick, which would bypass the need for hospital visits for blood draws, further innovating patient care in this field.
“Patients whose disease is no longer measurable after treatment often live in uncertainty for years”, said Hans Jacobs, Medical Immunologist. “With the new blood test, you can monitor much better, providing clarity. When the current blood test shows the cancer's return, the number of cancer cells is already high, and a different therapy is initiated. With the new test, we see the increase in cancer cells much earlier. This may allow for quicker and better adaptation of therapy to the patient’s situation, but we don’t know that yet. We will investigate this.”
Image: The new test’s measurement is a thousand times more sensitive than current standard test (Photo courtesy of 123RF)
Computational Tool Improves Breast Cancer Diagnosis and Treatment
reast cancer is the most commonly diagnosed cancer globally, presenting in various subtypes that require precise identification for effective, personalized treatment. Traditionally, cancer subtyping has been conducted through histological staining (immunohistochemistry), which involves identifying specific markers that categorize tumors into distinct subtypes. Recently, high-throughput transcriptomic profiling has transformed the way breast cancer subtypes are identified by analyzing gene activity in cancer cells through the total messenger RNAs present, which correspond to gene sequences and are used by ribosomes to synthesize proteins.
Transcriptomic profiling utilizes RNA sequencing (RNAseq), a rapidly evolving molecular biology technique that sequences RNA strands efficiently. As RNA sequencing becomes more affordable, it holds the potential for routine clinical integration to aid in diagnosis and treatment decisions. However, its application is currently limited by the requirement for processing large sample batches simultaneously and difficulties in comparing samples across different platforms. Now, scientists have developed a computational tool that collates breast cancer transcriptomic data from various databases, enhancing preci-
table finding is that EMBER's estrogen receptor signaling score surpasses the immunohistochemistry-based ER index used in clinics, suggesting EMBER's higher accuracy in predicting responses to endocrine therapy. By offering a consolidated platform for breast cancer transcriptomic data, EMBER facilitates a deeper understanding of molecular subtypes and treatment responses, potentially leading to more tailored treatments and improved outcomes for patients with ER+ breast cancer. EMBER also presents a viable method for integrating RNA sequencing into standard diagnostic procedures, promoting more comprehensive and cost-effective cancer diagnostics. This method not only advances precision oncology but also establishes a solid framework for further research and clinical applications.
croarray data from major datasets like TCGA and METABRIC, focusing on early-stage breast cancer patients. The data is normalized to a common scale, selecting the 1000 most variable genes and using 44 stable genes for normalization to maintain important gene expression features.
EMBER was validated with independent patient cohorts and tested on clinical trial data, such as the POETIC trial, identifying potential therapy resistance mechanisms like increased androgen receptor signaling and decreased TGFβ signaling. It accurately identified the five molecular subtypes of breast cancer and crucial pathways, including estrogen receptor signaling and cell proliferation. A no-
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Image: The tool can improve precision oncology by accurately predicting molecular subtypes and therapy responses (Photo courtesy of Shutterstock)
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Drug-Resistant Typhoid-Like Infection from Microscopy Images within Hours
Antimicrobial resistance is becoming a serious global health concern, making many infections increasingly difficult to treat and limiting available treatment options. This escalation in resistance raises the concern of some infections soon becoming untreatable. A major challenge for healthcare providers is quickly distinguishing between organisms that respond to standard first-line drugs and those that are resistant. Traditional testing methods, which involve culturing bacteria, testing them against various antimicrobial agents, and either manual or machine analysis, can take several days. This delay often leads to the administration of ineffective drugs, which can cause more severe health issues and potentially contribute to the development of further drug resistance. Researchers have now demonstrated that artificial intelligence (AI) can significantly cut down the time needed to accurately diagnose drug-resistant infections. They have developed an algorithm capable of correctly identifying drug-resistant bacteria from microscopy images alone.
In research published in Nature Communications, the team of researchers from the University of Cambridge (Cambridge, UK; www. cam.ac.uk) created a machine-learning tool that can identify from microscopy images the bacteria Salmonella typhimurium, which is resistant to the first-line antibiotic ciprofloxacin, without needing to directly expose the bacteria to the drug. S. Typhimurium is known to cause gastrointestinal and typhoid-like illnesses, with symptoms such as fever, fatigue, headache, nausea, abdominal pain, and constipation or diarrhea, which can be life-threatening in severe cases. Although treatable with antibiotics, the bacteria are increasingly developing resistance to several drugs, complicating treatment efforts.
The research team utilized high-resolution microscopy to study S. Typhimurium isolates subjected to varying concentrations of ciprofloxacin, identifying the five most crucial imaging features to differentiate between resistant and susceptible strains. They trained a machine-learning algorithm to recognize these features from the imaging data of 16 samples. Impressively, the algorithm could accurately determine whether the bacteria were susceptible or resistant to ciprofloxacin without direct exposure to the drug, and it achieved this using isolates cultured for just six hours—significantly less than the usual 24 hours required to culture a sample with antibiotics.
Although isolating the bacteria from a clinical sample, such as blood, urine, or stool, is still necessary, not having to expose the bacteria to ciprofloxacin can shorten the overall testing time from several days to
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just a few hours. While there are practical and economic constraints to this approach, it illustrates the potential of AI to significantly advance the battle against antimicrobial resistance. The researchers are now planning to expand their studies to include larger bacterial collections, aiming to refine their method to enhance speed and allow for the detection of resistance to ciprofloxacin and other antibiotics in various bacterial species.
“Given that this approach uses single cell resolution imaging, it isn’t yet a solution that could be readily deployed everywhere. But it shows real promise that by capturing just a few parameters about the shape and structure of the bacteria, it can give us enough information to predict drug resistance with relative ease,” said Dr. Sushmita Sridhar, who initiated this project while a PhD student in the Department of Medicine at the University of Cambridge. “What would be really important, particularly for a clinical context, would be to be able to take a complex sample – for example blood or urine or sputum – and identify susceptibility and resistance directly from that. That’s a much more complicated problem and one that really hasn’t been solved at all, even in clinical diagnostics in a hospital. If we could find a way of doing this, we could reduce the time taken to identify drug resistance and at a much lower cost. That could be truly transformative.”
Image: Color-enhanced scanning electron micrograph showing Salmonella Typhimurium (red) invading cultured human cells (Photo courtesy of Rocky Mountain Laboratories, NIAID, NIH)
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.
Firstly, I want to emphasize our ongoing commitment to supporting Young Scientists through specific programmes and initiatives. Through the IFCC Task Force we are offering workshops, mentorship programs, and collaborative research opportunities (PEP) for Young Scientists to learn, grow, and contribute to the scientific community.
National society meetings continue to be a cornerstone for laboratory professionals, providing essential platforms for knowledge exchange and professional growth. I encourage you to actively engage in these meetings.
Our IFCC webinars continue to be a great success. Recently, we had an insightful, and very well-attended session on Different Approaches to Bioethics, addressing the issues related to the use of data through AI, and I’m pleased to confirm that the following webinar focused on Minimum Quality Specifications based on the state of the art was very successful. The contribution of respected and authoritative speakers helps keep the IFCC community at the forefront of clinical chemistry and laboratory medicine.
Additionally, I want to draw your attention to the call for studies by the Task Force on Outcome Studies in Laboratory Medicine (TF-OSLM). This is a great opportunity to contribute to impactful research and advancements in our field. Don’t
miss the opportunity to submit your proposal –see all details in the IFCC website pages (www.ifcc. org).
I’m also delighted to see an increasing number of corporate members participating in the IFCC activities and showing interest in EuroMedLab Brussels. Their participation underscores the growing collaboration between the IFCC and industry, which is crucial for our collective progress.
Lastly, I’m excited to announce that we will be organizing a General Conference - the usual IFCC family meeting. This will be a wonderful occasion for us to come together, share our experiences, and envision the future course of our federation.
I invite all members and partners to stay engaged and participate in these exciting initiatives. Thank you for your continued dedication and contributions to the IFCC community.
With my best regards, Prof. Dr. Tomris Ozben IFCC President
MEMORIAM
Dr. Tan It Koon: Clinical Biochemist, Artist, Pianist, Renaissance Man
by Joseph Lopez
DrTan It Koon, the founding President of the Singapore Association of Clinical Biochemists (SACB) and the APFCB, passed away on May 1st this year. Dr Tan was a pioneer clinical biochemist who loomed large in the Asia-Pacific region. During his lifetime, he served our profession with distinction and received acclaim as an artist, calligrapher and concert pianist.
Dr Tan graduated from the University of Singapore (now the National University of Singapore) with a First Class BSc Honours degree. He spent his entire professional life at the Department of Pathology of the Singapore General Hospital, where, as its Head, he managed its laboratory services, conducted training and undertook research. Dr Tan completed his PhD in Biochemistry in 1970, while working at the department and subsequently undertook post-doctoral studies in the United Kingdom and in the United States. In addition, he obtained professional qualifications in clinical biochemistry, these being the Mastership in Clinical Biochemistry (MCB), the Fellowship of the Royal College of Pathologists UK (FRCPath) and the Fellowship of the American Academy of Clinical Biochemistry (FACB).
In early 1991, at the request of the Singapore Government, he established a national reference laboratory for the investigation and diagnosis of inherited metabolic disorders. The results of the 13-year study in this area were shared at congresses and in publications. Later, at the request of the Deputy Prime Minister of his country, he authored a position paper on the value of Biotechnology in Singapore and organised an international Symposium on Biotechnology. These activities resulted in the establishment of the first Institute for Molecular and Cellular Biology (IMCB) in Singapore.
Dr Tan became a clinical biochemist just as the field was emerging as a profession in its own right. This led him to initiate the formation of the SACB, which he served as President for several years. With colleagues from Australia, he founded the APFCB, of which he was elected the first President. Together, they pioneered the APFCB congresses, with the first two held in Singapore, in 1979 and 1982. In his capacity as an APFCB office holder for many years, Dr Tan was also actively involved in the organisation of several subsequent congresses. He started the APFCB News in 1983 and was its editor for many years.
Dr Tan was the first Asian to be elected to the IFCC Executive Board. As a WHO
consultant and member of its various Expert Committees, he conducted educational training courses for clinical laboratory staff in the Asia-Pacific region. As a member of the Asian-Pacific Scientific Advisory Board of Becton Dickinson for over 10 years, he was involved in the publication of the BD Analyte Notes and the conduct of courses on pre- and non- analytical errors. He published more than 150 articles in local and international peer-reviewed journals, he was a speaker or session chairman at various national and international conferences, and he served on the editorial board of several journals and books.
Dr Tan’s innate talent in art and music became manifested in early childhood. His musical studies commenced under Singapore’s most well known music teachers, just before entering primary school. He was fortunate to be tutored throughout his secondary school and beyond by Singapore’s first generation of artists who were recipients of the prestigious National Cultural Medallion Awards. Dr Tan gave his first public piano recital at the Victoria Memorial Hall, in Singapore, in 1957 and subsequently won top prizes for piano performances in 1959 and in the early 1960s. He was the winner of the Yamaha Singapore-Malaysia Music Composition Competition in mid-1970, where his winning composition was performed by the National Theatre Choir with him on the piano.
Dr Tan was an accomplished artist. His paintings during high school days won top awards at art exhibitions. He was invited to participate in the annual National Day art exhibitions organised by the Singapore Ministry of Culture from 1970. His more recent paintings accompanied with description, from the past decade and earlier, have appeared in the APFCB News and Clinical Chemistry. His outstanding achievements in the arts resulted in him being appointed by the Singapore Cabinet to the top management of the National Theatre Trust, a body dedicated to the promotion of cultural development and the performing arts.
Dr Tan spoke several Chinese dialects and languages. Even while he was busy working full-time in clinical biochemistry, his involvement with music, painting and calligraphy never ceased. He gave piano recitals at public concerts and private musical soirees. Even in his latter years, he painted and practised his calligraphy and piano, often well into the night. In recent decades, his art works have been exhibited annually in Singapore and abroad. Dr Tan served as the President of the South-
east Asian Art Association and chaired its art exhibition organising committee for a number of years. He adjudicated the annual national level calligraphy competition for schools and tertiary institutions and was appointed adviser for promotion of cultural heritage and art at the Ngee Ann Corporation and Chaozhou Clan Association more than a decade ago. More recently, Dr Tan’s profile and artworks earned him a chapter in each of four art books published in China featuring distinguished ethnic Chinese artists.
Dr Tan’s immense contributions to the sciences and arts resulted in him being presented with two National Day Awards by the Government of Singapore and appointment to the Boards of the Cultural Foundation and Science Council of Singapore. Recognition by his peers in laboratory medicine came by way of international awards, including the inaugural APFCB Distinguished Service Award.
The European Renaissance from the 14th century to the 17th century was an intense period of cultural, artistic, political and economic flourish. Some of the greatest thinkers, authors, statesmen, scientists and artists in human history emerged during this era. The Renaissance Man, an ideal which evolved from that time, recognised that the human kind had limitless capacities for development in multiple spheres of endeavour. The foremost embodiment of the Renaissance Man was perhaps Leonardo da Vinci, whose extraordinary gifts were manifest in the fields of art, science, music, invention and writing.
Dr Tan It Koon was a rare and exceptionally talented person. Requiescat in pace, Renaissance Man.
The writer is a founding member of the Malaysian ACB, a past President of the APFCB and a past member of the IFCC Executive Board who knew Dr Tan from the mid-1970s. We remained in touch until recently.
Celebrating Healthcare Excellence in Latin America
Latin America is a beautifully diverse region with expanding needs across many sectors, including healthcare. The ability to answer those needs often requires innovative thinking, teamwork and an enduring passion to drive transformational change. Many such initiatives have been globally recognized for their successful outcomes including three teams with recognition via the UNIVANTS of Healthcare Excellence awards. All three winning teams within Latin American had unified across traditional silos, achieving cross-disciplinary outcomes with measurable differences for patients, clinicians, payors and entire their health system.
From Hospital Israelita Albert Einstein, São Paulo, Brazil, a team led by João Carlos de Campos Guerra, MD, PhD, MBA, Professor of Medicine, Coagulation Specialist, Head of Haematology at the Laboratory, received honors of distinction for reducing catastrophic adverse events in patients with hemorrhagic shock. This was achieved by system-wide alerts, logistical/procedural changes, activation of dedicated resources (Rapid Response and Code H teams), and accelerated turn-around for critical tests and quicker decision-making. To learn more about this best practice, please visit here.
The Associação Fundo de Incentivo a Pesquisa (AFIP) in Sao Paula, Brazil also received global honors through the UNIVANTS of Healthcare Excellence awards with recognition of Achievement for their initiative during the COVID-19 pandemic. Their initiative focused on enhancing staff satisfaction and resource utilization. Through a new employee health program, this team helped to minimize the impact of the COVID-19 pandemic through concert-
IFCC OFFICE
Via Carlo Farini 81, 20159 Milan, ITALY Tel: (39) 02-6680-9912 • E-mail: ifcc@ifcc.org Web: www.ifcc.org
ed efforts to rapidly diagnose COVID-19 while monitoring and preventing new cases, and also providing mental health services to those in need. To learn more, please visit here.
Lastly, an integrated clinical care team from Biomédica de Referencia, Mexico City, Mexico received recognition of Achievement for improving population health through hepatitis C screening and treatment of undetected viral infections. Through comprehensive awareness campaigns, complementary HCV population screening, and ensuring treatment strategies that linked all positive patients to relevant education and care, this multidisciplinary team helped bring awareness to, while mitigating a significant public health concern aimed at improving overall population wellness. To learn more about this screening initiative, please visit here.
If you are a passionate about healthcare excellence and are actively collaborating across disciplines, now is the time to apply. We invite you to spotlight Latin America on the global stage with prestigious recognition through the UNIVANTS of Healthcare Excellence award program. It is free to apply and can be done online
with ease. The deadline for 2025 recognition is Nov 15th.
Partners of the UNIVANTS of Healthcare Excellence award program include Abbott, International Federation of Clinical Chemistry and Laboratory Medicine (IFCC), Association for the Diagnosis of Laboratory Medicine (ADLM, formerly branded as 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). Applications must be free from industry bias and do not take into account any product or partner affiliation upon scoring, The award program recognizes valued and innovative healthcare teams by recognizing, amplifying, and celebrating best practices in healthcare that are facilitated through insights, engagement and leadership fueled by laboratory medicine.
For more information on past winners, best practice examples and/or to apply for global recognition before the November 15th deadline, please visit www.UnivantsHCE.com.
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Highly-Sensitive Test to Help More Easily Diagnose B-Cell Lymphoma
B-cell lymphoma, a cancer primarily originating in the lymphatic system, represents about 85% of non-Hodgkin lymphoma (NHL) diagnoses. NHL ranks as the tenth most prevalent cancer globally, claiming over 250,000 lives annually. In its early stages, NHL can manifest with symptoms such as swollen lymph nodes, fever, fatigue, loss of appetite, or a red rash. These symptoms, however, can mimic the body’s typical response to infections, making a precise diagnosis crucial. symptoms of lymphoma can appear similar to the body’s normal reactive response to an infection. Now, a first-of-its-kind assay can offer diagnostic certainty for patients with suspected B-cell lymphoma.
Roche (Basel, Switzerland; www.roche.com) has introduced the first clinically approved, highly sensitive in-situ hybridization (ISH) test, the VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail assay, available in regions accepting the CE Mark. This assay stands out as the first clinically approved ISH test designed to detect the entire range of B-cell lymphoma subtypes. It assists pathologists in distinguishing between a B-cell malignancy and a normal, reactive condition stemming from an infection.
This test’s enhanced sensitivity allows for the evaluation of over 60 different B-cell lymphoma subtypes and plasma cell neoplasms using just a single tissue slide. It is capable of analyzing small biopsies and formalin-fixed tissues, thus eliminating the necessity for fresh tissue samples, which might be unavailable, particularly when lymphoma was not initially suspected. The characteristics of this test not only conserve tissue but also potentially reduce the need for additional biopsies, simplify the diagnostic process for pathologists, and expedite both diagnosis and treatment access for patients.
Sysmex and QIAGEN to Expand Genetic Testing Alliance
ysmex Corporation (Kobe, Japan; sysmex.co.jp) has expanded its strategic alliance agreement with QIAGEN N.V. (Venlo, The Netherlands; www. qiagen.com) to deepen their cooperation in genetic testing, encompassing areas such as research and development, manufacturing, clinical development, and sales-marketing.
Sysmex has been a significant player in the in vitro diagnostics arena for over five decades, continually advancing its genetic testing capabilities. A key aspect of this advancement is the deployment of liquid biopsy technologies in product development to deliver personalized medicine solutions to both patients and healthcare professionals. With a robust global sales and service network backed by premier laboratories in Japan and
Beckman Coulter to Licence Antibody for Alzheimer’s Test
Beckman Coulter Diagnostics (Brea, CA, USA; www.beckmancoulter.com) has signed a licensing agreement with ALZpath Inc. (Carlsbad, CA, USA; www. alzpath.bio) to use its top-tier ALZpath pTau217 antibody in a blood-based in vitro diagnostic (IVD) test on its DxI 9000 Immunoassay Analyzer.
Blood-based assays using ALZpath’s proprietary pTau217 antibody offer diagnostic accuracy comparable to traditional methods like PET imaging and cerebral spinal fluid (CSF) testing, but they are more accessible and affordable, involving a simple, less invasive blood test that can be performed in various clinical settings. The DxI 9000 Immunoassay Analyzer, available worldwide, is Beckman Coulter’s latest immunoassay platform. It features the unique Lumi-Phos PRO substrate, facilitating the development of clinically relevant, highly sensitive assays that meet the evolving demands of healthcare. The DxI 9000 combines this enhanced sensitivity with leading throughput, reliability, reproducibility, and quality in core laboratory operations, along with a comprehensive menu of tests.
“We recognize the critical need for more sensitive, precise, and scalable diagnostic testing for Alzheimer’s disease,” said Kathleen Orland, senior vice president, general manager, Chemistry, and Immunoassay for Beckman Coulter Diagnostics. “We selected ALZpath’s pTau217 antibody following rigorous evaluation due to its high performance in detecting amyloid pathology and ability to integrate into our advanced DxI 9000 platform to support broad-based testing. We are excited about the combination of ALZpath and Beckman Coulter innovations coming together to develop a new fully automated, high throughput, blood-based Alzheimer’s disease test for the millions of patients who suffer from dementia worldwide.”
the USA, Sysmex is dedicated to furthering the innovation of diagnostic technologies and high-value testing. Meanwhile, QIAGEN stands as a leader in precision medicine and a primary partner for pharmaceutical and biotech companies, developing companion diagnostics that identify genetic variances to inform clinical treatment decisions. QIAGEN’s technological suite ranges from polymerase chain reaction (PCR), multiplex PCR, digital PCR (dPCR), to next-generation sequencing
(NGS), offering tailored solutions to over 30 global pharmaceutical partners through master collaboration agreements.
Since their initial alliance in 2013 and their decision to forge a strategic partnership for companion diagnostics in 2021, Sysmex and QIAGEN have seen considerable collaborative success. With the recent expansion of this partnership, the companies aim to leverage their combined expertise in genetic testing to produce high-value offerings for their global clientele. Under the new terms, Sysmex will integrate QIAGEN’s assays into the clinical trials it conducts for pharmaceutical companies and research institutions across its global network of laboratories, enhancing QIAGEN’s global service capabilities.
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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; laboratoriumsmedizin-kongress.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
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
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; 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 30 - May 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 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. Jul 5-9; Istanbul, Turkey; 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
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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