LabMedica International November 2024

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Parkinson’s Detected 20 Years Prior to Symptoms

Parkinson’s disease is the second most common neurodegenerative disorder globally, affecting approximately 8.5 million people today. This debilitating condition is characterized by the destruction of dopamine-producing neurons in the brain’s

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New Technology Uses DNA Barcodes to Map Out Diverse Protein Interactions in Cells

Proteins play a vital role in almost all life processes, and understanding how these essential molecules interact is crucial in both biology and medicine. Protein interactions drive critical functions in health and disease, and decoding these interactions

Emerging Multi-Cancer Tests

can enhance predictions of cell behavior and offer significant clinical applications, from improved diagnostics to more effective therapies. However, current methods for studying protein interactions have limitations, such as producing false results and failing to

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Earlier Detection of Neurological Disorders

NEmerging Multi-Cancer Tests Enable Earlier Detection, Higher Survival

Earlier Detection, Higher Survival Rates

Rates

owered by machine learning (ML), newly-developed non-invasive Multi-Cancer Early Detection (MCED) tests can revolutionize cancer diagnostics and treatment by offering much earlier screening for multiple cancer types, all from a single blood or urine sample.

Rapid POC Sepsis Test Based on New Biomarker

Sepsis is a critical global health issue, impacting 50 million people annually and causing 11 million deaths, which accounts for 20% of all global fatalities. Sepsis is an emergency where time is of the essence, and up to 80% of sepsis-related deaths are preventable. However, it remains notoriously

Drop

Infrared spectroscopy, a method using infrared light to study the molecular composition of substances, has been a foundational tool in chemistry for decades, functioning similarly to a molecular fingerprinting system via a device known as a spectrometer.

When utilized on complex biofluids like blood plasma, this physico-chemical technique provides in-depth molecular insights, indicating its potential for medical diagnostics. Despite its established role in chemistry and industry, infrared spectroscopy has yet to Screening Tool Detects Multiple Health Conditions from Single Blood

eurotransmitters are essential for regulating neural function and overall well-being in humans and animals, ensuring a balanced hormonal environment for optimal body functioning. Dopamine is particularly critical, significantly influencing cognitive functions like motor skills and emotions such as happiness and pleasure. Apart from its role in regulating emotions, dopamine

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Platform Measures Over 100 Alzheimer’s Biomarkers

Early detection of Alzheimer’s disease-related pathological changes, such as neuroinflammation, impaired brain blood vessel function, and disrupted nerve cell communication, is crucial for enhancing the effectiveness of new infusion treatments and slowing disease progression. Gaining a detailed understanding of molecular changes in individuals at risk for Alzheimer’s, before they

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Platform Measures Over 100 Alzheimer’s Biomarkers

experience cognitive or memory decline, would help scientists monitor disease progression and eventually establish guidelines for early intervention. However, the current diagnostic methods for Alzheimer’s are not ideal—they are time-consuming, resource-intensive, and can be burdensome for patients who must undergo repeated invasive procedures.

Now, scientists at University of Pittsburgh (Pittsburgh, PA, USA; www.upmc.com) have independently validated a new blood test platform capable of measuring over 100 biomarkers related to Alzheimer’s disease. This platform could improve clinicians’ ability to capture the complex pathology of Alzheimer’s and streamline early diagnosis. In a proof-of-concept study, the research team tested blood samples from a cohort of 113 cognitively normal older adults living in a financially underserved region of Southwestern Pennsylvania. The samples were sent to Alamar Biosciences (Fremont, CA, USA; www.alamarbio.com) for analysis using a novel blood biomarker panel called the NULISAseq

CNS Disease 120 Panel. This panel, in addition to measuring classic Alzheimer’s blood biomarkers like phosphorylated tau, amyloid beta, neuroinflammation marker GFAP, and nerve cell damage marker NEFL, also tracks changes in about 120 other proteins related to neurodegenerative diseases.

The performance of the NULISA platform was independently validated against conventional assays for classic Alzheimer’s biomarkers for each sample. Biomarker profiles over two years were also compared with imaging-based measures of amyloid, tau, and neurodegeneration. According to findings published in Molecular Neurodegeneration, the NULISAseq panel identified several biomarkers that correlated with amyloid positivity and changes in amyloid levels over time. These biomarkers, previously associated with Alzheimer’s disease, had typically only been measured in cerebrospinal fluid and included proteins related to neuroinflammation, vascular changes, and impaired nerve cell communication. The researchers expect the platform to track blood biomarker changes over time in individuals both asymptomatic and undergoing treatment. Additionally, they are working on a predictive model that correlates biomarker changes detected by NULISAseq with brain autopsy data and cognitive assessments collected over several years. Their ultimate goal is to identify blood biomarkers that can aid in staging Alzheimer’s disease and predicting its progression, helping inform clinical management and treatment decisions.

“Alzheimer’s disease should not be looked at through one single lens,” said senior author Thomas Karikari, Ph.D., M.Sc., assistant professor of psychiatry at Pitt. “Capturing aspects of Alzheimer’s pathology in a panel of clinically validated biomarkers would increase the likelihood of stopping the disease before any cognitive symptoms emerge.”

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Image: Scientists have validated a new lab test platform for blood biomarkers of Alzheimer’s disease

Emerging Multi-Cancer Tests Enable Earlier Detection, Higher Survival Rates

urvival rates for cancer can be as low as 10% when diagnosed at an advanced stage, but with early detection, they can reach up to 90% for many cancer types. Currently, only three types of cancer can be screened using simple blood tests, and each test can detect only one specific cancer at a time. Multi-cancer early detection technologies aim to provide a new approach to complement traditional cancer screening programs. Unlike traditional screening tests that examine individual tissues or organs, multi-cancer early detection (MCED) screening tests analyze biomarkers within blood and urine using next-generation sequencing (NGS) and computational algorithms to predict the presence and type of different cancers. Liquid biopsies are utilized to detect circulating free tumor DNA (cfDNA), circulating free tumor proteins, DNA methylation patterns, circulating free immune cell DNA and DNA fragment size. MCED tests screen for multiple cancer types simultaneously and aim to increase detection rates, particularly at earlier stages when a cancer may be more amenable to treatment.

One such test is the novel Enlighten MCED test from Proteotype Diagnostics (Cambridge, UK; www.proteotype.com) that offers a revolutionary approach to detecting early-stage cancers by focusing on the body’s response to tumor development. While many cancer diagnostics rely on tumor-released signals, such as cfDNA, which is often only detectable once cancer has progressed, measures the host response to tumor development, tracking changing levels of proteins that occur even in the earliest stages of cancer. Enlighten does not require highly expensive, specialized equipment or consumables. Affordable laboratory kits applied to crude patient plasma enable easy scale-up for mass screening. With low data requirements and results within 24-hours of sample measurement, it is well positioned for widescale adoption. Proteotype has been awarded GBP 1.5 million in funding to support clinical validation of its Enlighten MCED test. Initial results have been promising with Proteotype reporting a detection rate of 86% across multiple cancers, a 0% false-positive rate and strong signals for early-stage cancers.

Another new revolutionary multi-cancer diagnostic test that is advancing in trials aims to detect symptoms before they develop. Scientists from the University of Southampton (Southampton, UK; www. southampton.ac.uk) have been awarded GBP 2.5 million to continue their work on a blood-based, multi-cancer diagnostic test, called miONCO. The test uses a panel of biomarkers and artificial intelligence (AI) to identify 12 cancers simultaneously, across

Image: The Enlighten test detects early-stage cancers by focusing on the body’s response to tumor development (Photo courtesy of Proteotype Diagnostics)

any stage, from a sample using just 10 to 15 drops of blood. miONCO boasts a 99% accuracy rate with an exceptionally low false positive rate, correctly identifying 50 cancers for every false positive. Scientists are currently conducting further studies to enhance the test, aiming to make it faster and more affordable, with a target price of GBP 120 per test. An ongoing study will assess 8,000 samples from a diverse group of individuals to ensure the test’s reliability across different genders, ethnicities, and backgrounds

Meanwhile, another innovative non-invasive test for the detection of multiple cancers has reported encouraging results in its first validation study. The Venient Sx MCED test developed by Kience Inc. (Wilmington, DE, USA; www.kience.com) is based on a blood and urine sample and promises to provide early and accurate screening for up to 42 different types of solid tumors and 5 hematological malignancies (even in the early stages), before the first symptoms and signs appear. Designed to be much less invasive and more economical, it offers fewer false positives by leveraging a machine learning algorithm developed by Kience as well as the Barcelona Criteria for higher accuracy. Results of the first validation study presented recently by Kience at ESMO 2024 show that without the application of the Barcelona Criteria, the algorithm achieved a sensitivity of 100% but a specificity of only 67%, with a positive predictive value (PPV) of 21%. In contrast, when applying the Barcelona Criteria, the specificity was 100% and the PPV improved considerably, also reaching 100%.

Multi-cancer early detection tests represent an emerging health technology that could disrupt traditional models of cancer screening. Multi-cancer early detection tests may help complement existing screening programs and potentially diagnose more cases of cancer. By potentially using a single, non-invasive, and relatively convenient test to assess the presence of multiple types of cancer, it may be possible to detect more cancers at an earlier stage when accompanied with established screening programs. They may also enable early detection of cancer types for which there are no screening tests available.

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 Diagnoses Brain Cancer in

lioblastoma, an aggressive and currently incurable brain cancer, typically leaves the average patient with a life expectancy of 12-18 months post-diagnosis. Now, a groundbreaking device is capable of diagnosing glioblastoma in less than an hour. This device's central component is a biochip that employs electrokinetic technology to identify biomarkers, specifically active Epidermal Growth Factor Receptors (EGFRs), which are commonly overexpressed in several cancers, including glioblastoma, and found in extracellular vesicles.

Extracellular vesicles, or exosomes, are unique and considerably large nanoparticles secreted by cells. To develop the device, the research team at the University of Notre Dame (Notre Dame, IN, USA; cbe.nd.edu) faced a dual challenge: distinguishing active from non-active EGFRs and building a diagnostic tool that could sensitively and selectively

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detect active EGFRs on extracellular vesicles from blood samples. Their solution was a biochip integrating an economical electrokinetic sensor the size of a ballpoint pen ball. This setup allows antibodies on the sensor to bind multiple times to a single vesicle, greatly enhancing both the sensitivity and specificity of the diagnosis. Additionally, synthetic silica nanoparticles are used to signal the presence of active EGFRs on captured vesicles, contributing a strong negative charge that causes a voltage shift detectable when active EGFRs are present, signaling glioblastoma.

This innovative charge-sensing approach reduces the common interferences seen in other sensor technologies that rely on electrochemical reactions or fluorescence. The diagnostic system comprises three main components: an automation interface, a portable machine prototype that supplies the necessary materials for the test, and

the biochip itself. Each analysis, which consumes only 100 microliters of blood and is completed in under an hour, requires a new biochip, costing less than USD 2 to produce, while the automation interface and prototype are reusable. While initially developed for glioblastoma, this technology is versatile enough for potential adaptation to other diseases by detecting various biological nanoparticles.

“Our electrokinetic sensor allows us to do things other diagnostics cannot,” said Satyajyoti Senapati, a research associate professor of chemical and biomolecular engineering at Notre Dame and co-author of the study. “We can directly load blood without any pretreatment to isolate the extracellular vesicles because our sensor is not affected by other particles or molecules. It shows low noise and makes ours more sensitive for disease detection than other technologies.”

Screening Tool Detects Multiple Health Conditions from Single Blood Drop

become a standard tool in medical diagnostics. To tackle this issue, scientists have developed a diagnostic tool that employs infrared light and machine learning to identify multiple health conditions in just one measurement at the population level.

The team from the BIRD group at Ludwig Maximilian University of Munich (LMU, Munich, Germany; www.lmu.de) had previously worked on methods to measure human plasma. In their most recent study, they introduced infrared molecular fingerprinting to a naturally diverse group, analyzing blood from thousands of participants in the KORA study—a long-standing health research project based in Augsburg, Germany. Adults from this study were selected randomly for medical examinations and blood donations, giving the KORA study a new dimension and purpose. Over 5,000 blood plasma samples were assessed using Fourier transform infrared (FTIR) spectroscopy. This approach involved analyzing the blood

samples with infrared light to obtain molecular fingerprints, which were then examined using machine learning to correlate with existing medical data. The findings revealed that these fingerprints could facilitate quick health screenings. The multi-task algorithm was capable of differentiating various health states, including abnormal blood lipid levels, changes in blood pressure, and the presence of type-2 diabetes, including its precursor, pre-diabetes, which often goes unnoticed. Published in Cell Reports Medicine 2024, the research highlighted the algorithm’s ability to also identify individuals who were healthy and remained so over the years. This discovery was notable because finding entirely healthy individuals in a random population is challenging due to the commonality of health variations and the natural changes that occur over time.

Traditionally, different tests are required for each condition, but this new method identifies multiple health issues simultaneously, not just one at a time. The system not only identifies

healthy people but also detects complex conditions involving multiple diseases and can predict the onset of metabolic syndrome years before symptoms manifest, offering a chance for early intervention. This foundational study proposes that infrared molecular fingerprinting could become an integral part of routine health screenings, allowing for more effective detection and management of conditions, particularly metabolic disorders like diabetes and abnormal cholesterol levels.

As this technology evolves and its capabilities expand through further technological development and clinical studies, more health conditions could be added to its diagnostic range. This advancement may lead to personalized health monitoring, where individuals regularly assess their health status to identify potential problems early on. Ultimately, the integration of infrared spectroscopy with machine learning is poised to revolutionize health diagnostics, providing a new, efficient means to monitor health globally using just a drop of blood and infrared light.

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New Technology Uses DNA Barcodes to Map-Out Diverse Protein Interactions in Cells

capture the full range of protein interactions. For example, the widely used yeast-two hybrid assays focus on pairwise binary interactions and require genetic manipulation, making them unsuitable for clinical samples. Similarly, mass spectrometry-based proteomics often misses weak interactions due to extensive sample processing and evaluates protein interactions in a binary fashion. These existing methods fall short in detecting complex, higher-order interactions where multiple proteins form large functional assemblies—crucial in aggressive cancers.

Now, a team of researchers from the NUS Institute for Health Innovation & Technology (iHealthtech, Singapore; www.ihealthtech. nus.edu.sg) has developed a novel technology called TETRIS to map out diverse protein interactions in cells using DNA barcodes. This innovative approach allows the identification and quantification of multiple interacting partners in large protein assemblies. By capturing the complex hierarchy of protein interactions within tumor cells, TETRIS uncovers the molecular mechanisms driving disease progression.

This leads to more accurate diagnostics, enabling the sub-typing of cancers and identifying aggressive forms of the disease within hours, a capability previously unavailable. Additionally, TETRIS offers insights for personalized treatment strategies by pinpointing specific proteins and their interactions that drive cancer growth, opening the door to targeted therapies that can improve patient outcomes.

TETRIS leverages DNA nanotechnology to map protein interactions directly in patient samples. It uses hybrid molecular structures as smart encoders, each carrying a target-recognizing antibody and a templated DNA barcode. These encoders bind to interacting proteins and fuse their barcodes with neighboring units, capturing both the molecular identity and spatial relationships of the proteins. Unlike traditional methods, TETRIS can measure both pairwise and higher-order protein interactions, providing a comprehensive view of the complex protein interaction network, or interactome. A key feature of TETRIS is its ability to encode and decode protein interactions directly in clinical samples. The technology has been successfully tested on human breast cancer tissue biopsies, where it accurately diagnosed cancer subtypes and revealed higher-order protein interactions linked to cancer aggressiveness. These findings were published in the scientific journal Nature Biomedical Engineering.

TETRIS offers a more detailed and accurate understanding of the molecular mechanisms behind diseases, greatly benefiting cancer diagnostics and treatment. By detecting changes in higher-order protein interactions—often markers of aggressive cancers—this technology enables more personalized clinical decisions. Designed for scalability and adaptability, TETRIS can process large numbers of samples and deliver rapid results using existing lab infrastructure, making it suitable for integration into routine clinical workflows. For instance, in a doctor’s office, samples obtained through fine-needle aspiration—a minimally invasive biopsy—can be quickly analyzed to guide treatment decisions. The researchers plan to expand TETRIS to other types of cancers and neurological diseases, potentially leading to new diagnostic tools and treatments for a range of illnesses.

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Earlier Detection of Neurological Disorders

also acts as a biomarker for screening certain cancers and neurological disorders. Variations in dopamine levels are linked to a range of neurodegenerative diseases, including Parkinson’s and Alzheimer’s, as well as neurodevelopmental and psychological disorders like ADHD, Tourette’s Syndrome, bipolar disorder, and schizophrenia. Accurate measurement of dopamine levels is crucial for advancing both pharmaceutical research and clinical therapies. Now, a newly developed integrated optical sensor capable of detecting dopamine directly from unprocessed blood samples offers a cost-effective and efficient method for screening various neurological conditions and cancers, thus potentially enhancing patient outcomes.

The plasmonic sensor developed at University of Central Florida (Orlando, FL, USA; nanoscience.ucf.edu) utilizes a small gold pattern that causes electrons to oscillate collectively in what are known as plasmons, intensified by a specific optical setup. The introduction of a molecule to the sensor’s environment alters electron movement, modifying the light reflection off the sensor and facilitating molecule detection. In contrast to traditional biosensors that depend on biological components such as antibodies or enzymes, this novel sensor employs a specially crafted aptamer, a synthetic DNA strand, that targets dopamine specifically. This design not only reduces costs and extends the shelf life of the sensor but also allows for the direct detection of dopamine in unprocessed blood, eliminating the need for sample preparation. This innovation is particularly valuable in resource-limited settings, simplifying the diagnostic process and potentially allowing for the detection of other conditions using similar technology.

The researchers optimized molecule detection by applying an aptamer to the sensor’s active area, designed to bind precisely to targeted biomarkers. The findings published recently in Science Advances, demonstrate the sensor’s ability to rapidly and accurately diagnose diseases. This advancement builds on previous work where the team enhanced the sensor’s selectivity and broadened its clinical applications by substituting cerium oxide nanoparticles with DNA-based aptamers, thus enabling the direct detection of dopamine in various biological samples without the need for prior sample preparation.

“This plasmonic biosensor is extremely sensitive to low concentrations of biomolecules, which make them promising platform for specialized assays, point of care applications in remote locations,” said UCF NanoScience Technology Center Professor Debashis Chanda, the study’s principal investigator. “In this work, we demonstrated an all-optical, surface-functionalized plasmonic biosensing platform for the detection of low concentrations of neurotransmitter dopamine directly from diverse biological samples which includes protein solutions, artificial cerebrospinal fluid, and unprocessed whole blood.”

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Precision Medicine Blood Test Predicts Heart Disease Prior to Symptoms

AMPEL BioSolutions (Charlottesville, VA, USA; www.ampelbiosolutions. com) has published a paper in the peer-reviewed journal Cell iScience that validates and expands upon the inflammatory and immune system abnormalities in the blood of individuals predisposed to heart disease, which the company first identified two years ago. By analyzing genes expressed in single cells isolated from atherosclerotic coronary artery plaques, the study revealed biomarkers that can be measured using AMPEL’s CardioGENE blood test. This innovative approach, which connects genetic predisposition to real-time molecular pathways targeted by specific drugs, has the potential to transform healthcare by enabling physicians to assess cardiovascular disease risk and select appropriate treatments.

Notably, the publication shows that common genetic risk factors contributing to cardiovascular disease in non-autoimmune individuals are the same as those in patients with autoimmune inflammatory diseases such as lupus, psoriasis, type 1 diabetes, rheumatoid arthritis, primary biliary cirrhosis, and celiac disease, all of whom face increased cardiovascular event risks.

annonse_trykk2.pdf 1 02/10/2024 21:43

AMPEL’s findings build on a cardiologist-led study published in The Lancet last year, which demonstrated that inflammation, as measured by standard tests like CRP or ESR, predicts cardiovascular risk in individuals even after lipid levels have been normalized with medication. This is the first time that cardiovascular genetic risk factors have been identified in immune and inflammatory system genes across autoimmune diseases, even in the absence of traditional risk

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factors like smoking, high cholesterol, or elevated blood pressure. AMPEL’s CardioGENE blood test is now poised for development as a decision-support biomarker tool. This development marks AMPEL's expansion into genetic testing, complementing its existing expertise in RNA analytics and explainable predictive AI. By identifying the relevant molecular pathways, CardioGENE will

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Rapid POC Sepsis Test Based on New Biomarker

difficult to diagnose due to its non-specific symptoms, which often mimic other common conditions. Early detection is essential for initiating the appropriate treatment protocols and improving patient survival rates. Pancreatic Stone Protein (PSP) has emerged as a promising biomarker for the early detection of sepsis, identifying the condition 24-48 hours earlier than current methods. PSP, produced by the pancreas and immune cells, rises in response to infection and inflammation and has shown significant sensitivity and specificity in detecting sepsis, particularly in critically ill patients. Clinical studies have found that elevated PSP levels are closely linked to the progression of sepsis, enabling healthcare providers to initiate life-saving treatments sooner and improve patient outcomes.

Abionic (Epalinges, Switzerland; www.abionic.com) has developed the IVD CAPSULE PSP test, which offers rapid, accurate, and easy-to-use results in critical care settings by measuring PSP levels. These measurements are directly tied to a patient’s sepsis risk, empowering clinicians to make well-informed decisions and initiate timely treatments. The IVD CAPSULE PSP operates exclusively on Abionic’s abioSCOPE platform, a near-patient rapid diagnostic system that integrates smoothly into clinical workflows. It provides lab-quality results from a drop of blood within minutes, delivering valuable insights and actionable

Precision

Medicine Blood Test Predicts Heart Disease Prior to Symptoms

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help healthcare providers prevent major cardiovascular events through targeted prophylactic treatments. Notably, FDA-approved drugs such as colchicine, along with biologics that target inflammatory cytokines and immune cells, are candidates for these preventive therapies.

“The CardioGENE blood test identifies inherited genetic markers in blood samples that drive pathways, which can be targeted by drugs,” said Dr. Amrie Grammer, AMPEL Co-Founder, President and Chief Scientific Officer. “We are confident that CardioGENE will make a difference in the lives of all Americans especially those with autoimmune inflammatory diseases who disproportionately suffer from the disease’s cardiovascular impacts.”

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“Achieving FDA 510(k) clearance for IVD CAPSULE PSP marks a significant milestone

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Simple Blood Draw Helps Diagnose Lung Cancer 10 Times Faster

Once dismissed as cellular waste, exosomes—tiny vesicles released by cells containing proteins, DNA, or RNA fragments— have emerged as vital players in cell-to-cell communication over the past decade. While exosomes from healthy cells carry important signals throughout the body, those from cancer cells can facilitate tumor spread by preparing tissues to receive tumor cells before they arrive. Exosomes carry proteins both inside and on their surfaces, and these surface proteins are often chiral, meaning they have a right- or lefthanded twist, which influences how they interact with light. In cancer exosomes, these surface proteins are frequently mutated, meaning the protein’s molecular structure has been altered by genetic changes. Such mutations subtly affect the protein’s shape, which in turn shifts its chirality. These alterations can be detected by analyzing how the proteins interact with circularly polarized light, which can “match” the twist of the proteins. When the twist aligns, a strong signal is returned to a light detector. However, these light signals are usually weak and difficult to interpret and detecting exosomes involves extracting them from blood samples, which is challenging because of their tiny size, ranging from just 30 to 200 nanometers.

Researchers at University of Michigan (Ann Arbor, MI, USA; che. engin.umich.edu) have now developed a microchip capable of capturing exosomes from blood plasma to detect lung cancer. This new diagnostic method, which uses a simple blood draw, is 10 times faster and 14 times more sensitive than previous approaches, according to the research team. To identify exosomes, the team designed gold nanoparticles in the shape of twisted disks, adapted to capture exosomes within a central cavity. These cavities are tailored to perfectly match the size, shape, and surface chemistry of the exosomes, allowing for reliable capture. With a right-handed twist, the nanoparticles resonate strongly with right-twisting light but reflect little signal when exposed to left-twisting light—a phenomenon known as circular dichroism. Once the exosomes are trapped in the cavities, the proteins they carry can either amplify or diminish the return signal based on their shape.

The gold nanoparticle cavities, arranged along the tiny channels of a microfluidic chip, successfully captured exosomes from blood plasma and differentiated between samples from healthy individuals and those with lung cancer, as reported on September 27 in the journal Matter. The microfluidic chips, called CDEXO chips (Circular Dichroism detection of EXOsomes), could also potentially distinguish specific lung cancer mutations, aiding doctors in tailoring treatments to target the most prevalent mutations as they evolve. The researchers envision

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the CDEXO chip initially being used alongside traditional diagnostic methods, with the potential to expand its use to screen for other cancers, improving early detection efforts as trust in the technology grows.

“As a next step, we want to look at most known solid tumor mutated proteins to understand how their spectral signatures are different,” said Sunitha Nagrath, U-M professor of chemical and biomedical engineering and co-corresponding author of the study. “From here, we can push the technology to further increase those spectral differences to distinguish between proteins.”

Innovative AI Tool Uses Digitized Whole-Slide Images for Intermediate-Risk Prostate Management

Prostate cancer estimates for the United States in 2024 include approximately 299,010 new cases and about 35,250 deaths. Among patients in the intermediate-risk group, around 60% lack a clear treatment plan, and 30 to 50% experience cancer progression after the initial therapy. Early identification of patients at higher risk of rapid disease progression is critical for improving outcomes. Recent advances in artificial intelligence (AI), particularly in deep learning, have accelerated the development of new technologies that use medical images to predict diseases more accurately. Researchers have now developed an AI-powered tool to enhance the management and prognosis of prostate cancer.

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Image: A scanning electron microscope image of chiral gold nanoparticles developed for a new microfluidic chip (Matter, 2024; DOI: 10.1016/j. matt.2024.09.005)

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Point-of-Care Testing Device Accurately Measures Cortisol Levels in Blood

Stress manifests in various forms, and the inability to manage high stress levels can lead to severe health problems like depression and Alzheimer's disease. The development of a cost-effective, reproducible, and easy-to-use point-of-care testing device that accurately measures cortisol—a key stress biomarker in the blood—has been a significant goal of researchers. Such a device could greatly facilitate the quick diagnosis of elevated cortisol levels, thereby significantly enhancing quality of life. However, the electrodes used in currently available devices are not stable under varying conditions such as changes in pH and temperature, resulting in a limited shelf life and difficulties in commercial production.

Now, researchers at Xi'an Jiaotong-Liverpool University (XJTLU, Suzhou, China; www.xjtlu.edu.cn) have developed an innovative cortisol detector that addresses these challenges. Traditional cortisol sensors

Cont’d on page 17

Image: A new and improved detector can accurately measure levels of cortisol – a stress biomarker in the blood (Photo courtesy of XJTLU/https:// doi.org/10.1016/j.talanta.2024.126776)

Innovative AI Tool Uses Digitized Whole-Slide Images for Intermediate-Risk Prostate Management

The tool, called PATHOMIQ_PRAD, was created by researchers at the Icahn School of Medicine at Mount Sinai (New York, NY, USA; www.icahn.mssm.edu) in partnership with PathomIQ, Inc. (Cupertino, CA, USA; www. pathomiq.com). It focuses on intermediaterisk prostate cancer patients and utilizes deep learning to extract morphological features from datasets based on biopsy or surgical hematoxylin- and eosin-stained whole-slide images. The tool helps identify patients at higher risk of rapid disease progression and aims to provide more accurate predictions for earlier intervention, leading to more targeted and personalized treatment plans. PATHOMIQ_ PRAD scores range from 0 to 1, with higher scores signifying high-risk features. The study used large datasets to classify patients into highand low-risk groups based on pre-set clinical cutoffs of 0.45 for biochemical recurrence (BCR) and 0.55 for metastasis, which were

determined by factors such as the likelihood of cancer recurrence or spread.

The findings reported on September 3 in the online issue of European Urology show that PATHOMIQ_PRAD outperformed existing benchmark cancer outcome tools in predicting five-year outcomes. The researchers plan to conduct large-scale clinical validation studies with a more diverse patient population. They are also pursuing regulatory approval to develop PATHOMIQ_PRAD as a Lab Developed Test, making it available in CLIA-certified labs. Furthermore, the team is working to integrate the tool with advanced genomic profiling methods, including spatial transcriptomics and mass cytometry, to deepen the understanding of the biological factors behind the regions identified by PATHOMIQ_PRAD.

“By analyzing various tissue types— epithelial, stromal, and immune cells—it generates a detailed score for each patient, predicting outcomes and offering a powerful

new way to guide treatment decisions,” said Dimple Chakravarty, PhD, Assistant Professor of Urology at Icahn Mount Sinai. “Ours is the first AI tool designed specifically for intermediate-risk prostate cancer patients that is both scalable and generalizable. It can be used for risk stratification from biopsy and surgery specimens. It’s affordable, quick, and adaptable for use in various healthcare settings.

Image: A cluster map of different prostate cancer patterns detected by the AI tool PATHOMIQ_ PRAD from stained tissue images (Photo courtesy of Nair, et al. (2024), European Urology)

Cont’d from page 14

Substantia Nigra. Currently, Parkinson’s disease is diagnosed primarily based on clinical symptoms such as tremors or gait disturbances, along with associated questionnaires. However, these symptoms typically appear at a relatively advanced stage of the disease, by which time over 50%, and in some cases up to 80%, of the dopaminergic neurons in the Substantia Nigra have already been lost. As a result, available treatments are limited, mainly addressing motor issues.

A key feature of Parkinson’s is cell death caused by the accumulation of the alpha-synuclein protein. This protein begins to aggregate approximately 15 years before symptoms appear, and cell death starts 5-10 years before diagnosis is possible using current methods. This leaves a significant diagnostic window of up to 20 years, during which the disease could potentially be detected and prevented before symptoms manifest. If the process is identified early in individuals aged 30, 40, or 50, it may be possible to prevent further protein aggregation and subsequent cell death. Researchers at Tel Aviv University (Tel Aviv, Israel), in collaboration with three major Israeli medical centers, have now developed a novel method for detecting protein aggregation in cells. This technology could allow for diagnosis up to 20 years before the onset of motor symptoms, paving the way for early intervention or prevention of the currently incurable disease.

This new approach utilizes super-resolution microscopy combined with computational analysis to precisely map the molecules and structure of protein aggregates. Previous research has shown that alpha-synuclein aggregates also form in other parts of the body, including the skin and digestive system. In the current study, the researchers examined skin biopsies from 7 people with Parkinson’s disease and 7 people without the condition. Using a unique microscope and a technique called super-resolution imaging, combined with advanced computational analysis, the team was able to map the distribution and aggregation of

alpha-synuclein molecules. The findings, published on September 3 in Frontiers in Molecular Neuroscience, revealed a higher concentration of protein aggregates in individuals with Parkinson’s compared to those without the disease. Additionally, nerve cell damage was observed in areas with large concentrations of the pathological protein. With this proof of concept, the researchers plan to expand their study by analyzing a larger sample of 90 biopsies—45 from healthy individuals and 45 from those with Parkinson’s disease—in order to further explore differences between the two groups.

“Our technology will enable the detection of initial signs of Parkinson’s at the cellular level up to 20 years before the first motor symptoms appear. We hope that such early diagnosis will facilitate preventive treatment for this currently incurable disease,” the researchers noted.

Point-of-Care Testing Device Accurately Measures Cortisol Levels in Blood

Cont’d from page 16

use reference electrodes with a silver layer that tends to oxidize and destabilize during electrochemical measurements. In the new study published in the journal Talanta, the researchers introduced iridium oxide nanoparticles to coat the silver layer, significantly enhancing the stability, sensitivity, and reproducibility of cortisol measurements in point-of-care settings. This is the first application of iridium oxide in this manner. The resulting device is simple and affordable, capable of detecting cortisol levels at concentrations 3,000 times lower than the typical cortisol

range found in blood, making it highly suitable for commercial use. Additionally, the iridium oxide-modified electrodes have increased the selectivity of the tests, improving the device’s overall efficacy.

"One problem with the current solutions is that there is much similarity between cortisol and other hormones such as progesterone, testosterone, and corticosterone. This means it is difficult for the detectors to tell them apart,” said Dr. Graham Dawson, XJTLU Associate Professor and co-author. “Our iridium oxide-modified electrode is selective enough to distinguish the different hormones and helps to solve this issue."

Image: Steps and methodology of skin biopsy processing for dSTORM (Photo courtesy of Front. Mol. Neurosci. 2024)

DNA TOPOISOMERASE I ELISA ORGENTEC DIAGNOSTIKA

Anti-Scl-70 is an ELISA test for quantitative determination of IgG antibodies against Scl-70 (DNA topoisomerase I) in human serum or plasma. These antibodies are a highly specific marker for progressive systemic scleroderma.

Novel Light-Based Technique Could Revolutionize Cancer Diagnosis

Aquicker, cheaper, and less painful cancer detection technique developed using light has the potential to revolutionize cancer diagnosis, early detection, and monitoring.

Researchers at Aston Institute of Photonic Technologies (AiPT, Birmingham, UK; www.aston.ac.uk) have developed a new technique for analyzing crystals in dehydrated blood. Utilizing a novel polarizationbased image reconstruction method, the team examined polycrystalline structures within dried blood samples. This analysis is vital as proteins in the blood undergo structural transformations in their tertiary (unique 3D shape) and quaternary forms (how multiple proteins assemble) during the onset of diseases such as cancer.

The new technique allows for a comprehensive layer-by-layer analysis of dry blood smears, a critical factor in distinguishing between healthy and cancerous samples. The research involved 108 blood film samples divided into three equal groups: healthy individuals, prostate cancer patients, and patients with aggressive cancer cells. The findings published in the Nature journal Scientific Reports showed a 90% accuracy rate in early diagnosis and classification of cancer, surpassing the efficacy of traditional screening methods. Moreover, this approach uses blood samples rather than tissue biopsies, making it a less invasive and safer option for patients.

“Our study introduces a pioneering technique to the liquid biopsy domain, aligning with the ongoing quest for non-invasive, reliable and

URINE SEDIMENT ANALYZER DIRUI INDUSTRIAL

The FUS-360 urine sediment analyzer measures 25 formed element parameters and one unique parameter and has a throughput of 120 tests/hour. It automatically distinguishes abnormal RBC and shows the ratio in the testing result.

efficient diagnostic methods,” said AiPT Professor Igor Meglinski. “A key advancement in our study is the characterization of the mean, variance, skewness, and kurtosis of distributions with the cells which is crucial for identifying significant differences between healthy and cancerous samples. This breakthrough opens new avenues for cancer diagnosis and monitoring, representing a substantial leap forward in personalized medicine and oncology.”

First-Ever Blood Test Diagnoses Maternal Autoantibody Related Autism

Maternal Autoantibody Related Autism (MARA) is a subtype of autism linked to the presence of specific autoantibodies in a mother. The identification of MARA marks a significant breakthrough in the early, even pre-symptomatic, detection of autism in children. MARA has been associated with more severe forms of autism and is estimated to account for about 20% of all autism cases. Now, a groundbreaking blood test can accurately determine whether a woman carries the autoantibodies responsible for MARA. This test can be used to diagnose MARA in children at birth or even predict its likelihood before pregnancy.

MARAbio Systems (Salt Lake City, UT, USA; www.marabio.com) has created precision technology capable of predicting a child’s likelihood of having MARA through a simple maternal blood test, even before symptoms emerge or before pregnancy. The MARAbio test measures up to eight specific autoantibodies, and their combinations, that are linked

to a form of autism affecting nearly 20% of diagnosed cases. This test allows for the detection of the MARA subtype of autism in a child before symptom onset and can also aid in diagnosing MARA in children with developmental delays. Additionally, it can be used by women at higher risk before pregnancy to assess their likelihood of having a child with MARA-related autism.

The MARAbio test offers the potential to accelerate the diagnosis of autism and the initiation of therapy for children born to mothers who test positive. Early behavioral intervention is known to improve the quality of life for individuals with autism, and identifying the MARA subtype may enable therapists to customize intervention strategies for better outcomes. The test can also be useful for prepregnancy screening in high-risk women and may support the development of therapeutic approaches to reduce the risk of having a child with MARA.

A schematic of the 3D MM imaging experimental setup used in the studies of blood films (Photo courtesy of Ushenko, AG)

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AI Model Identifies Gender-Specific Risks Associated with Brain Tumors

For years, cancer researchers have observed that men are more likely than women to develop glioblastoma, a deadly and aggressive form of brain cancer with a median survival of just 15 months after diagnosis. Additionally, these tumors tend to be more aggressive in men. However, identifying specific characteristics that could help predict which tumors will grow faster has remained a challenge. Now, researchers are turning to artificial intelligence (AI) to uncover these risk factors and explore how they differ between men and women.

Scientists at the University of Wisconsin (Madison, WI, USA; idia. labs.wisc.edu) are utilizing AI’s computational capabilities to analyze large datasets of medical images, aiming to find patterns that could assist oncologists in making more informed decisions for their patients. Their goal is to address the entire range of challenges that cancer patients face, from diagnosis and prognosis to assessing treatment response. In this study, the researchers focused on digital images of pathology slides— thin sections of tumor samples—in an effort to detect patterns that might predict how fast a tumor could grow and, consequently, how long a patient might survive. Accurate prognosis is critical, as it influences treatment decisions and impacts patients’ quality of life after diagnosis.

To tackle this problem, the researchers developed an AI model capable of detecting subtle patterns in pathology slides that might be imperceptible to the human eye. They trained the model using data from over 250 glioblastoma studies, teaching it to recognize distinctive tumor features such as the abundance of certain cell types and the extent of the tumor’s invasion into nearby healthy tissue. Additionally, the model was trained to identify correlations between these features and patients’ survival times, while also considering their sex. Through this approach, the team created an AI model that can identify risk factors for more aggressive tumors, with distinct patterns associated with each sex.

For women, higher-risk characteristics identified by the AI model included tumors that were infiltrating into healthy tissue. In men, the presence of pseudopalisading cells—cells that surround dying tissue—was linked to more aggressive tumors. The researchers’ initial findings, published on August 23 in Science Advances, revealed that the model also detected tumor traits associated with poorer prognoses for both sexes. The team is now extending their work to MRI data and has started using AI to analyze other cancers, such as pancreatic and breast cancers, with the goal of improving patient outcomes. This study could pave the way for more personalized treatment approaches for glioblastoma patients.

BIOCHEMICAL ANALYZER LABTEST

The Audmax 400 analyzer is designed for biochemical and immunoturbidimetric tests, with onboard preparation of hemolyzed for HbA1c. It has a constant speed of 400 tests/hour and maximum speed of 800 tests/hour with optional ISE.

Images show regions of glioblastoma tumors in females (top) and males (bottom). AI models predict presence of relatively higher risk (red) and lower risk (blue) areas (Photo courtesy of Tiwari Lab/UW–Madison)

“There’s a ton of data collected in a cancer patient’s journey,” said radiology and biomedical engineering professor Pallavi Tiwari. “Right now, unfortunately, it’s usually studied in a siloed fashion, and this is where AI has huge potential. By uncovering these unique patterns, we hope to inspire new avenues for personalized treatment and encourage continued inquiry into the underlying biological differences seen in these tumors.”

AI-Based Tissue Staining Detects Amyloid Deposits Without Chemical Stains or Polarization Microscopy

Systemic amyloidosis, a disorder characterized by the buildup of misfolded proteins in organs and tissues, presents significant diagnostic difficulties. The condition affects millions of people each year, often resulting in severe organ damage, heart failure, and high mortality rates if not diagnosed and treated early. Traditionally, the detection of amyloid deposits has relied on Congo red staining viewed under polarized light microscopy, which has been considered the gold standard. However, this method is time-consuming, costly, and prone to variability that can lead to misdiagnoses. Researchers have now developed a groundbreaking method for imaging and detecting amyloid deposits in tissue samples. This innovative approach uses deep learning and autofluorescence microscopy to create virtual birefringence imaging and histological staining, removing the need for polarization imaging and traditional stains like Congo red.

The new technique, developed by researchers at the University of

Cont’d on page 21

AI-Based Tissue Staining Detects

Amyloid Deposits Without Chemical Stains or Polarization Microscopy

California, Los Angeles (UCLA, Los Angeles, CA, USA; org.ee.ucla.edu)), employs a single neural network to convert autofluorescence images of unstained tissue into high-resolution brightfield and polarized microscopy images. These images resemble those produced by conventional histochemical staining and polarization microscopy. The method was tested on cardiac tissue samples and demonstrated that the virtually stained images consistently and accurately identified amyloid patterns. This approach eliminates the need for chemical staining and specialized polarization microscopes, potentially accelerating diagnosis and lowering costs. The virtual staining process matched and even surpassed the quality of traditional methods, as confirmed by multiple boardcertified pathologists from UCLA.

forward in the field of amyloidosis pathology. It not only simplifies the diagnostic process but also holds potential for expanding the use of digital pathology in routine clinical practice, particularly in resource-limited settings.” Cont’d from page 20

The study’s results, which were published in Nature Communications on September 12, indicate that this virtual staining technique could be easily incorporated into current clinical workflows. The method does not require specialized optical components and can be deployed on standard digital pathology

Dscanners, making it accessible to a broad range of healthcare facilities. Researchers plan to extend their evaluations to other tissue types, including kidney, liver, and spleen, to further validate the technique’s effectiveness across various forms of amyloidosis. They also aim to develop automated detection systems to assist pathologists in identifying problematic regions, potentially enhancing diagnostic accuracy and minimizing false negatives.

“Our deep learning model can perform both autofluorescence-to-birefringence and autofluorescence-to-brightfield image transformations, offering a reliable, consistent, and cost-effective alternative to traditional histology methods. This breakthrough could greatly enhance the speed and accuracy of amyloidosis diagnosis, reducing the risk of false negatives and improving patient outcomes,” said Dr. Aydogan Ozcan, the senior author of the study and the Volgenau Chair for Engineering Innovation at UCLA. “This innovation represents a significant step

Experimental Blood Test Improves Detection of Early-Stage Pancreatic Cancer

etecting pancreatic cancer early significantly increases survival rates, but current diagnostic tools are limited. Now, an experimental blood test has shown greater effectiveness in identifying early-stage pancreatic cancer compared to other available methods. The findings, published online on September 17 in Cancer Letters, set the stage for further clinical evaluation, an important step toward its approval as a diagnostic tool for pancreatic cancer.

This advancement stems from a longstanding collaboration among cancer researchers, including those from Van Andel Institute (Grand Rapids, MI, USA; www.vai. org), who are part of the National Cancer Institute’s Early Detection Research Network (EDRN). The study results from double-blind assessments of several pancreatic cancer biomarker candidates conducted by EDRNaffiliated labs at Van Andel Institute and other institutions. It is the first instance in which multiple biomarkers for pancreatic cancer, identified by different labs, have been evaluated together. The new test detects two sugars — CA199.STRA and CA19-9 — produced by pancreatic cancer cells and released into the bloodstream. CA19-9 is currently the gold-standard biomarker for pancreatic cancer.

Researchers at Van Andel Institute previously identified CA199.STRA as a cancer biomarker and developed the technology to detect it. While the CA19-9 test alone accurately identified only 44% of pancreatic cancer samples in the lab, the addition of CA199.STRA increased the accuracy to 71%. The combined test significantly reduced false negatives while maintaining a low rate of false positives. This balance is crucial because low false positive and negative rates indicate the test’s ability to accurately detect cancer presence or absence. The analysis also showed that adding a protein biomarker called LRG1 to the combination of CA199.STRA and CA19-9 improved specificity, allowing the test to more accurately return negative results when no cancer is present. The three-biomarker panel was able to correctly identify nearly all cases while producing fewer false positives compared to using CA19-9 alone.

“Another take-home message from this study is the importance of having multiple different validated biomarkers for pancreatic cancer,” said the study’s co-corresponding author Brian Haab, Ph.D., a professor at Van Andel Institute. “A one-size-fits-all approach won’t work. It’s encouraging that we have many promising candidates that can be combined to better detect cancer.”

Image: Virtual birefringence imaging and histological staining of amyloid deposits in label-free tissue (Photo courtesy of Ozcan Research Group)

AUTO BIOCHEMISTRY ANALYZER

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Light-Induced Immunoassay

Selectively Detects Coronavirus Spike Proteins In 5 Minutes

ike moths drawn to a flame, microbes can also be influenced by light. Using this principle, researchers have developed a method to quickly detect viruses using only a small sample.

Scientists at Osaka Metropolitan University’s Research Institute for Light-induced Acceleration System (RILACS; www.p.s.osakafu-u.ac.jp) have developed a light-induced immunoassay for virus detection. By applying laser irradiation for less than a minute, they used a nanoparticle-imprinted plasmonic substrate with nanobowl structures (each 500 nm in diameter) coated with antibodies for the spike proteins of the novel coronavirus. A low-power 5-milliwatt laser, similar to commercial laser pointers, was able to form bubbles on the biochip that attracted virus-mimicking nanoparticles, speeding up the selective detection of these particles.

The process works because light-induced convection causes the nanoparticles to move and gather at a stagnant region between the substrate surface and the bottom of the bubble, meaning a high particle concentration isn’t necessary. The entire procedure—from coating the substrate to detecting the virus—can be completed in under 5 minutes, as reported in the journal npj Biosensing.

“This study shows that we can shorten the cumbersome antibody coating process and perform rapid and highly sensitive protein detection,” said OMU Professor Takuya Iida, the director of RILACS. “We believe our findings can contribute to the early diagnosis of not only the novel coronavirus, but possibly also various infectious diseases, cancer, even dementia.”

Liquid Biopsy Solution Enables

Non-Invasive Sample Collection and Direct Cell-Free DNA Stabilization from Urine

rine cell-free DNA (cfDNA) presents significant potential for research and future clinical applications. It facilitates the measurement and analysis of cfDNA fragments, detection of genetic alterations, assessment of methylation status, and generation of genomic data that may not be obtainable from blood samples. However, analyzing urine cfDNA has posed challenges, as cfDNA degrades quickly after collection, potentially releasing contaminating genomic DNA. Now, an innovative solution enables non-invasive sample collection and immediate stabilization of cfDNA in urine, making standardized urine sampling practical for clinical use.

PreAnalytiX GmbH (Hombrechtikon, Switzerland; www.preanalytix.com), a joint venture between QIAGEN N.V. (Venlo, The Netherlands; www.qiagen.com) and BD (Becton, Dickinson and Company, Franklin Lakes, NJ, USA; www.bd.com), has launched the PAXgene Urine Liquid Biopsy Set. This set enables the reliable analysis of cfDNA from urine using molecular testing technologies such as qPCR, digital PCR, and next-generation sequencing (NGS). The PAXgene Urine Liquid Biopsy Set tackles the challenge of accessing cfDNA in urine by integrating a preservation solution that stabilizes cfDNA at the point of collection. It is the first set to offer a validated, standardized, and comprehensive preanalytical workflow, making urine cfDNA analysis more accessible for research purposes.

The PAXgene Urine Liquid Biopsy Set marks a significant improvement in sample quality, standardization, and ease of use for researchers handling urine samples. It features a closed system for urine collection and cfDNA stabilization, offering flexibility for sample shipment and storage under various conditions. Additionally, it integrates seamlessly into established workflows and is compatible with QIAGEN’s industry-leading sample preparation products. Developed in line with Europe’s latest CEN/TS standards for the preanalytical handling of urine cfDNA, the set provides an optimized and standardized workflow.

Urine liquid biopsy has immense potential to aid researchers in detecting minimal residual disease, monitoring treatment responses, and identifying therapeutic targets, complementing blood plasma analysis for a more comprehensive understanding. However, unlike blood samples, there

has been a lack of well-established technical solutions for the collection, storage, transport, and processing of urine samples—until now.

The PAXgene Urine Liquid Biopsy Set bridges this gap. Commercialized by QIAGEN, the new set complements the company’s broader portfolio of liquid biopsy solutions, which cover various analytes (circulating cell-free nucleic acids, tumor cells, exosomes) and molecular detection technologies (NGS, qPCR, digital PCR), empowering researchers and clinicians to harness the full potential of liquid biopsy across diverse applications.

“With the innovative PAXgene Urine Liquid Biopsy Set, we are excited to address a pressing market need for a urine collection,

stabilization, transport and storage device that is integrated into a complete preanalytical workflow for the development of cfDNA-based tests,” said Dr. Uwe Oelmueller, PreAnalytiX Management Committee Co-Chair and Head of MDx Development Sample Technologies at QIAGEN. “Liquid biopsies have huge potential, but accurate results are highly dependent on the workflow. As a result, the stabilization of analyte profiles in samples is critical to ensure that test results are reliable and reproducible.”

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.

SEROLOGICAL PIPET CONTROLLER INTEGRA BIOSCIENCES

The PIPETBOY GENIUS serological pipet controller with repeat dispense function is faster and more accurate than pipetting according to graduation marks, allowing for consistent repeat dispensing of aliquots from 0.1 to 50 ml.

Blood Test Predicts Risk of Developing COPD and Other Respiratory Diseases

Chronic respiratory diseases, such as chronic obstructive pulmonary disease (COPD), impact millions of adults worldwide and were the third leading cause of death in 2019. Major risk factors include smoking, air pollution, and occupational exposure to chemicals or lung irritants like gas, fumes, and dust. A year-over-year decline in lung function is associated with poor respiratory health outcomes, yet clinicians currently lack an easy method to determine if a patient is experiencing a rapid deterioration in lung function. There is a pressing need for an easy-to-implement clinical tool that can capture an individual’s lung function trajectory at a single point in time, which would enable earlier interventions that could improve long-term lung health. Now, researchers have developed a preclinical blood test to identify adults most likely to develop severe respiratory conditions, including COPD.

The blood test was developed by a scientific team supported by the National Institutes of Health (NIH) and comprising investigators from Northwestern University Feinberg School of Medicine (Chicago, IL, USA; www.feinberg.northwestern.edu ) and University of California, Davis Medical Center (Sacramento, CA, USA; www.health. ucdavis.edu). The test analyzes 32 proteins that scientists identified as accurate predictors of an adult’s increased likelihood of requiring medical care for or dying from severe respiratory illness. The risk score was based on lung health data collected from nearly 2,500 U.S. adults over a 30-year period. To create this risk score, investigators first reviewed lung health data from 2,470

The Allplex GI-EB Screening Assay detects 7 key bacterial pathogens associated with gastroenteritis. This assay reports multiple Ct values of each pathogen in a single channel using a real-time PCR instrument.

adults aged 18 to 30 who participated in a 30-year cardiovascular health study. They then screened thousands of proteins from blood samples provided by participants at the 25-year mark and selected 32 that best predicted which participants were experiencing a rapid decline in lung function. These 32 proteins were compiled into a score to predict how likely a person would need medical treatment for or die from a lung condition or severe respiratory event.

Adults with higher scores had a 17% increased chance of requiring hospital care for respiratory illness, an 84% increased risk of developing COPD, and at least an 81% higher chance of dying from a respiratory disease such as COPD or pneumonia. Those with higher scores also had a 10% increased likelihood of experiencing respiratory exacerbations—such as cough, mucus production, or shortness of breath—that required treatment. Participants in the decades-long study underwent breathing tests to measure their lung function up to six times throughout the study and provided additional lung health data. During this period, 2,332 participants experienced a normal decline in lung function, while 138 experienced a sharp decline. To test the risk score, researchers retrospectively assessed respiratory disease risks in more than 40,000

adults from two earlier observational studies. The findings, published in the American Journal of Respiratory and Critical Care Medicine, show that the prediction model successfully identified adults who had the greatest chance of having severe respiratory conditions after accounting for multiple factors, including sex, race, body weight, asthma, and a history of smoking. This type of blood test still needs to be studied in clinical trials before it can be considered for approval by the Food and Drug Administration as a screening tool to help predict risks for chronic respiratory diseases.

“We are still not ready for this test to be used in practice, but it’s a promising advance,” said James P. Kiley, Ph.D., director of the Division of Lung Diseases at NIH’s National Heart, Lung, and Blood Institute (NHLBI), which funded the study. “It consolidates insights from decades of breathing tests and medical evaluations into a single tool that has the potential to identify patients at risk for severe disease and complications.”

Image: The blood test analyzes 32 proteins to predict the risk for developing severe respiratory conditions (Photo: Adobe Stock)

IFCC eAcademy Initiative: A Gateway to Expert Knowledge

The IFCC is pleased to present the IFCC eAcademy initiative, which has achieved remarkable achievements this year. The eAcademy (eacademy.ifcc.org) serves as a learning hub, offering registrants access to a wide array of webinars led by world-class speakers who are leaders in their respective fields.

IFCC’s commitment to delivering high-quality educational resources continues to give impressive results, and we encourage everyone to take full advantage of the materials available on our platform. This year alone, we have seen incredible engagement, with over 70,000 registrants from around the world. Since 2020, the IFCC has developed its LIVE WEBINAR Series, attracting between 2,500 and 5,000 attendees per webinar, from more than 160 countries, highlighting the truly international scope of this initiative. Each webinar not only provides invaluable insights into various topics but also includes a certificate of attendance, adding value to participants’ professional development.

The topics covered in the IFCC Webinars are diverse and designed to meet th e broad needs of the IFCC professionals. Whether you seek updates on the latest advancements in Laboratory Medicine or aim to deepen specific expertise, the eAcademy offers continuous learning opportunities for professional growth. The growing appreciation for this IFCC educational initiative is reflected in its increasing success, evidenced by both participant numbers and high engagement during and after each webinar.

As we look ahead, we are preparing the calendar for the upcoming year. Get ready for new 2025 IFCC Webinars Series, designed to further enrich your knowledge and skills in Laboratory Medicine. The IFCC remains committed to enhancing participants’ learning experiences, ensuring that the eAcademy remains a valuable resource for all involved.

Stay tuned for updates, and don’t miss the chance to participate in the 2025 eAcademy program!

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E-mail: ifcc@ifcc.org • Web: www.ifcc.org

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

IFCC Welcomes New Affiliate Member

Indian Association of Clinical Chemistry & Lab Medicine Practitioners (ACCLMP)

The IFCC welcomes the Association of Clinical Chemistry & Lab Medicine Practitioners (ACCLMP), a pan India organization comprising chiefly of specialists and those undergoing specialist training in Clinical Biochemistry as well as Laboratory Medicine.

The organization was established at the city of Kolkata, in the eastern part of India on 31st of January 2014. The ACCLMP family now comprises of 20 out of India’s total of 28 states with close to 1300 members, inclusive of primary /life members (medical specialist in Biochemistry or Lab Medicine or equivalent) having voting rights and the right to be elected in Executive Committee (EC) posts and affiliate members (post-graduate students of Biochemistry & Lab Medicine) eligible to avail all the facilities of the association except the right to contest elections for state & central ECs. The governance of the association is two-pronged, with each state having its own individual EC elected through annual state elections and a spearheading central EC whose members are elected by state EC representatives.

The association has successfully conducted 10 national conferences, one for every year of its existence, all as onsite physical events, with the 11th ACCLMPCON 2025 about to be held at Guwahati, Assam, India from 11th to 12th January 2025, with preceding 18 preconference CMEs. The association has to date organized more than 110 pre-conference CMEs & workshops. A total of 14 webinars were successfully conducted during the same time. Moreover, the national conferences along with their ancillary pre-conference CMEs during the pandemic period, were successfully executed as onsite physical events.

Presently, the association is successfully conducting a comprehensive academic program primarily for its affiliate members, in the form of online PG seminars and journal clubs.

Our association also boasts of its own biennial in-house journal, the Journal of Applied Biochemistry & Laboratory Medicine; JABLM (ISSN 2583-4142 (Online) – Both National & International ISSN), an open access peer-reviewed journal, since October 2020. April 2024 issue is available at https:// jablm.acclmp.com. Visit: www.acclmp.com

Meet Representatives from the IFCC Task Force for Young Scientists

The IFCC is happy to announce a new series of articles in the eNews. These articles will be featuring the Corresponding Members of the IFCC Task Force for Young Scientists. In the various issues, we’ll spotlight some young scientists from across the globe, offering readers an in-depth look into their professional journeys and the unique paths that have shaped their careers.

Through these articles, we will get to know each YS's current role, insights into their educational and career backgrounds, and read about the experiences that have inspired their passion for laboratory science. They will also introduce their national societies, along with the activities and resources these organizations offer to support Young Scientists in the early stages of their careers. Join us and connect with the next generation of scientific leaders and discover the community within the IFCC Task Force for Young Scientists. Stay tuned for the first profiles in the IFCC eNews!

Mild Head Injuries: New Pathways Improve Patient Triage and Assessment

The term mild traumatic brain injury (mTBI) is often used to describe injury to the brain caused by trauma and/or a sudden jolt. The long-term effects of any brain injury, however, is not mild. In fact, those with an mTBI, or concussion, experience symptoms ranging from headaches to cognitive problems, dizziness, and more. With this in mind, appropriate triage and treatment of those experiencing trauma to the brain is increasingly important for reducing long-term complications, enabling brain health, all while ensuring appropriate use of limited resources.

Opportunities for laboratory medicine to provide insights related to mTBIs are increasing, particularly with availability of novel biomarkers such as GFAP (Glial fibrillary acidic protein) and UCH-L1 (Ubiquitin C-Terminal Hydrolase L1) as found in human plasma or serum. Consequently, best practices highlighting the value of brain-biomarker driven initiatives have also emerged.

At the Hospital Universitario Virgen de las Nieves, in Spain, an integrated clinical care team sought to strategically implement blood biomarkers into clinical care. The novel TBI panel is used in conjunction with other clinical information to assist in determining the need for a CT scan of the head for patients 8 years of age or older, who present with suspected mild traumatic brain injury (mTBI, Glasgow Coma Scale score 13-15) within 12 hours of injury. As a result of this initiative, there has been a 10% reduction in CT scans within the first 3 months of implementation, as well as mitigated overuse of limited resources within the emergency department by 143 total ED hours in a 9-month period. This is coupled with an increase in clinical confidence, with 77.8% of clinicians indicating that the added insights from he panel helped reduce the uncertainty related to the absence of brain lesions, particularly in the non-elderly.

Another best practices out of Germany at the Klinikum Lüneburg identified that the decision to conduct CT scans relied heavily on the clinical judgement of the treating physician, which can result unnecessary CT scans and patient exposure to potentially carcinogenic doses of radiation. In order to assist in determination of the need for a CT scan, a new clinical pathway was introduced using UCH-L1 and GFAP to rule out the risk of intracranial lesions often seen on a CT scan in adult (18+) mild TBI patients with GCS 13-15 who are seen within 12 hours of trauma. Measured outcomes associated with this new pathway show a 41% reduction of CT scans for mTBI patients in the emergency department. This in turn has a positive impact across resource utilization and costs, all while improving patient safety.

Both of these integrated clinical care teams received Recognition of Achievement for their innovations and outcomes through the UNIVANTS of Healthcare Excellence award program in 2022 and 2024, respectively. To learn more about the best practices and others, and/or to apply for recognition through UNIVANTS, please visit www. UnivantsHCE.com.

IFCC Distinguished Awards: Call for Nominations

Awards to be presented at the IFCC EuroMedLab Congress to be held in Brussels in May 2025

The IFCC Distinguished Awards programme has been created for honouring scientists and clinicians in clinical chemistry, laboratory medicine, and related disciplines, recognizing their exceptional achievements in advancing scientific research, healthcare, and clinical laboratory science. These Awards highlight the outstanding contributions of selected individuals, raising awareness within both the scientific community and the public of their significant impact on basic or clinically-oriented research, diagnostic test development, and/or other contributions to improvements in healthcare or laboratory services improvements. By celebrating these accomplishments, the IFCC Distinguished Awards also aim to inspire and encourage other scientists to strive toward meaningful advancements in clinical laboratory science. These Awards represent the highest honor conferred by our Federation; they acknowledge and publicize the exceptional research and contributions of colleagues worldwide who have made profound improvements in medicine and healthcare.

On behalf of IFCC and its Awards Committee, I am pleased to announce the call for nominations for the following IFCC Distinguished Awards for presentation at the IFCC EuroMedLab Congress to be held in May 2025, in Brussels (Belgium).

1. IFCC-Henry Wishinsky Award for Distinguished International Service (since 1990) - IFCC Distinguished International Services Award (1981-1987).

2. IFCC Award for Distinguished Contributions in Education.

3. IFCC-Robert Shaffer Award for Outstanding Achievements in the Development of Standards for Use in Laboratory Medicine.

4. IFCC Distinguished Award for Contributions to Cardiovascular Diagnostics.

5. IFCC Young Investigator Award.

Following IFCC Distinguished Awards will also be presented in October 2026 in New Delhi (India) and a different call for nominations will be issued in due time:

1. IFCC Howard Morris Distinguished Clinical Chemist Award (since 2020) IFCC Distinguished Clinical Chemist Award (19672017).

2. IFCC Award for Significant Contributions in Molecular Diagnostics.

3. IFCC Distinguished Award for Laboratory Medicine and Patient Care.

4. IFCC-Gérard Siest Award Young Scientist Award for Distinguished Contributions in Pharmacogenetics.

5. IFCC Distinguished Woman Scientist Award for Contribution to In Vitro Diagnostics.

Nominations are welcome from the President or National Representative of the nominees’ national society, which should be a member of the IFCC. Each nomination should contain (1) a statement as to the reasons for nomination, (2) a full CV of the nominees including a bibliography, and (3) other letters of support (optional). They should be sent to the IFCC Office before the deadline. More information are available on the IFCC website.

For the Brussels Awards, the closing date for receipt of nominations is 31st December 2024.

Thermo-Resistant (- 60 °C to 300 °C) Fully Washable & Flexible Suitable for central sterilization services Sterilizable STERILIZABLE INSTRUMENT & WORK-SURFACE MATS

The QIAcuityDx is a single touchpoint, benchtop digital PCR (dPCR) system that seamlessly integrates partitioning/processing, PCR, and analysis. It performs fully automated processing of QIAcuityDx

Breath-Based Sampling System Diagnoses Lower Respiratory Tract Infection

Lower Respiratory Tract Infections (LRTIs) are the leading cause of death from infectious diseases. Current diagnostic methods rely heavily on clinical symptoms but often lack specificity, particularly given the prevalence of bacterial colonization without active infection. The use of human breath for noninvasive disease detection has long been recognized as a promising diagnostic tool, but the absence of effective biomolecular sampling technologies has limited progress. To overcome this challenge, a new sampling system has been developed to efficiently capture biomolecules from human breath. This system targets protease dysregulation, a known indicator of bacterial infections, by capturing proteases and enabling their activity-based detection, thus aiding in the diagnosis of LRTIs.

ZeteoTech’s (Sykesville, MD, USA; www.zeteotech.com)

BreathBiomics sampling system introduces an innovative capture mechanism that utilizes advanced surface chemistry to collect non-volatile organic compounds from exhaled breath. The system features chemically modified functional groups designed to have a high affinity for a broad spectrum of biomolecules, including lipids, metabolites, and proteins, allowing for a comprehensive analysis of respiratory health. By leveraging molecular interactions, the system effectively captures biomolecules contained in submicron particles, addressing a significant limitation of existing collection technologies.

LThe RIDA®UNITY Parasitic Stool Panel II test, performed on the RIDA® UNITY platform, is a multiplex real-time PCR for the direct qualitative detection of Giardia lamblia, Cryptosporidium spp., and Entamoeba histolytica DNA.

Additionally, the functional groups can be customized to target specific biomarkers, such as those associated with SARS-CoV-2, offering enhanced flexibility for biomarker detection and diagnosis.

The BreathBiomics sampling system is highly adaptable, integrating seamlessly into various respiratory devices such as facial masks, mouthpieces, mechanical ventilators, oxygen masks, incubators, and tracheostomy tubes. Its quiet operation, generating noise levels below 45 dB (similar to a home refrigerator), makes it ideal for use in clinical environments, including primary care settings, emergency rooms, operating rooms, and intensive care units. Whether used for clinical research or routine care, BreathBiomics has the potential to revolutionize the way clinicians detect and manage respiratory diseases.

Diagnostic Tool for Lyme Disease Testing Boasts Over 90% Accuracy

yme disease is on the rise globally, with an estimated 14% of the population having been infected at some point. Many of these individuals experience chronic symptoms due to delayed diagnosis. A recent study found that 38% of Lyme patients continue to suffer from symptoms six months after their initial diagnosis, highlighting the need for better testing methods. Until now, tests for Lyme disease have been less than 50% accurate, particularly in the early stages, leading to numerous cases of misdiagnosis or undiagnosed patients, resulting in prolonged suffering. Now, a new test with over 90% accuracy, capable of detecting the disease at all stages, including the crucial first 14 days post-infection, represents a potential breakthrough in Lyme disease diagnosis. Developed through a collaboration between Tulane University (New Orleans, LA, USA; www.tulane.edu) and Focus on Lyme (Phoenix, AZ, USA; www.focusonlyme.org), the new diagnostic, LymeSeek, is enhanced by machine learning and has the potential to transform Lyme

disease detection. The test’s high accuracy is achieved through a combination of multiple biomarkers and a unique algorithm, providing over 90% accuracy in all phases of the disease. Unlike other tests that claim similar accuracy but rely solely on two-tier testing, LymeSeek’s accuracy is based on samples from the early stages of the disease, including cases with erythema migrans (EM) rash, PCR, and/or punch biopsy results, which are often missed by current testing methods.

This patented test will enable timely and precise diagnosis of Lyme disease during its most treatable phase. The current diagnostic process for Lyme disease involves multiple steps, takes over a week, and requires subjective interpretation. LymeSeek aims to replace this lengthy procedure, facilitating earlier diagnoses and reducing the incidence of chronic illness caused by delayed or missed diagnoses. Ongoing efforts are focused on further development and manufacturing, with plans to pursue early FDA clearance, aiming to make LymeSeek available to the public by the third quarter of 2026.

Image: BreathBiomics is a novel mechanism to capture biomolecules in human breath (Photo courtesy of ZeteoTech)

Beckman Coulter and SphingoTec in Kidney Health Assesment Alliance

In an effort to enhance kidney health assessments in critical care, Beckman Coulter Diagnostics (Brea, CA, USA; www.beckmancoulter. com) has partnered with SphingoTec GmbH (Hennigsdorf, Germany; www.sphingotec.com) to integrate SphingoTec’s penKid assay into Beckman Coulter’s extensive test offerings on its Access Family of immunoassay analyzers. penKid (Proenkephalin 119-159), a real-time biomarker present in plasma, provides a more accurate and timely assessment of kidney function, especially in critical care environments. This collaboration marks the first central laboratory license for a penKid assay and seeks to significantly expand diagnostic capabilities for AKI worldwide by leveraging Beckman Coulter’s large installed base of instruments. Under this agreement, Beckman Coulter will develop and validate a fully automated diagnostic test for penKid using SphingoTec’s IVD-certified assay. This partnership will make penKid assays widely available in central laboratories, enabling critical care physicians to perform timely and accurate kidney health assessments.

Seegene and Werfen Finalize Technology Sharing Aggreement

Seegene (Seoul, South Korea; www.seegene.com), a leading PCR molecular diagnostics company, and Werfen (Barcelona, Spain; www. werfen.com), a global diagnostics specialist, have finalized a partnership agreement as part of a technology-sharing initiative. The agreement outlines plans for the two companies to establish a NewCo in Spain, named Werfen-Seegene, following required government approvals, expected by the first half of 2025. Werfen-Seegene will prioritize developing diagnostics for infectious diseases, including antimicrobial and drug resistance testing, viral load testing, monitoring organ transplant patients, sexually transmitted infections (STIs), and emerging regional diseases. Leveraging Werfen’s strong local infrastructure and network, the NewCo will create products tailored to Spain’s healthcare needs. Spain, the fourth-largest in vitro diagnostics (IVD) market in Europe, will serve as a strategic hub for expanding the initiative across Europe and globally.

LGC and AccuGenomics to Collaborate on Enhancing Cancer Testing Accuracy

LGC (London, UK; www.lgcgroup.com), a leader in clinical diagnostics and genomics, and AccuGenomics (Wilmington, NC, USA; www.accugenomics.com), a pioneer in molecular diagnostic development, have entered into a new strategic partnership. Through this collaboration, LGC and AccuGenomics intend to deliver enhanced solutions for cancer NGS testing quality control. LGC’s extensive clinical genomics reference

Cepheid and Fleming Initiative Join Forces to Fight Antimicrobial Resistance

Antimicrobial resistance (AMR) is responsible for over one million deaths globally each year and poses a growing challenge in treating major infectious diseases. To effectively tackle AMR, Cepheid (Sunnyvale, CA, USA; www.cepheid.com) has entered into a partnership with the Fleming Initiative, a global collaboration established by Imperial College Healthcare NHS Trust (London, UK; www.imperial.nhs.uk) and Imperial College London. The Fleming Initiative unites research scientists, policymakers, clinicians, behavioral experts, and public and commercial partners to create a global network aimed at developing equitable solutions to AMR. The initiative will leverage diverse expertise and public engagement to tackle AMR from multiple perspectives. The partnership will focus on catalyzing global action, particularly in regions where poverty, climate change, and health inequalities exacerbate the impact of drug-resistant infections.

material expertise, combined with AccuGenomics’ proprietary technology, will allow laboratories across the world to integrate third party controls into their procedures, ensuring more reliable, actionable patient results from NGS-based assays. Additionally, the companies will also develop custom reference materials for NGS assay validation, supporting the evolving landscape of precision diagnostics.

Nova and Terumo BCT Collaborate on Automated Cell Culture Sensing

Nova Biomedical (Waltham, MA, USA; www.novabiomedical.com) and Terumo Blood and Cell Technologies (Lakewood, CO, USA; www. terumobct.com) have entered into a collaboration to enable automated cell culture sensing with Terumo BCT’s Quantum Flex Cell Expansion System through integration with Nova’s BioProfile FLEX2 Automated Cell Culture Analyzer. Quantum Flex is an automated and functionally closedcell expansion system purpose-built to meet the needs of cell therapy developers throughout their commercialization process Incorporating automated cell culture sampling functions for comprehensive parameter analysis will help make Quantum Flex an even more compelling platform, helping developers build more effective workflows as they bring their therapies to market. The FLEX2 delivers online monitoring of gas, total and viable cell density, and cell viability by trypan blue dye exclusion method, and osmolality by freezing point depression, as well as comprehensive analysis of multiple key cell culture parameters.

NOVEMBER

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 Paki-

stan 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

13th Molecular Cytopathology Congress. Dec 9-10; Naples, Italy; molecularcytopathology.net

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

ESHRE 2025 – 41st Annual Meeting of the European Society of Human Reproduction and Embryology. Jul 7-10; Amsterdam, Netherlands; eshre.eu

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

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

AUGUST

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

EASD 2025 – 61st Annual Meeting of the European Association for the Study of Diabetes. Sep 15-19; Vienna, Austria; easd.org

ESCV 2025 – 27th Annual Conference of the

European Society for Clinical Virology. Sep 17-20; Thessaloniki, Greece; escv2025.org

23rd International Congress of Therapeutic Drug Monitoring & Clinical Toxicology. Sep 21-24; Singapore; iatdmct2025.org

MASCL 2025 – Congress of the Association for Mass Spectrometry & Advances in Clinical Lab. Sep 21-26; Montreal, Canada; msacl.org

OCTOBER

47th ISOBM Conference - International Society of Oncology and Biomarkers. Oct 13-15, Murnau am Staffelsee, Germany; isobm.org

DKLM 2025 – Annual Congress of the German Society for Clinical Medicine and Laboratory Medicine (DGKL). Oct 24-25; Leipzig, Germany; laboratoriumsmedizin-kongress.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

ASCP 2025 – Annual Meeting of the American Society of Clinical Pathology. Nov 17-20; Atlanta, GA, USA; ascp.org

MEDICA 2025. Nov 17-20; Dusseldorf, Germany; medica-tradefair.com

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