Forum COLA Names Keynote Speakers for Laboratory Enrichment Forum

Using microfluidic shear stress, the system detaches living cells from excised tissue to support pathology workflows and downstream diagnostic testing. Researchers at the Massachusetts Institute of Technology (MIT) and Johns Hopkins University have developed a handheld microfluidic device capable of gently collecting living cells from specific tissue locations to support cancer diagnostics , disease modeling, and personalized medicine development. Described in a study published in the journal Device , the system enables targeted sampling of newly excised tissue without compromising surrounding tissue structures. The technique was developed to address persistent diagnostic hurdles in ovarian cancer, where high-grade serous cases frequently originate in the fallopian tubes as microscopic precursor lesions that are difficult to sample. When ovarian cancer is identified in its earliest stages, five-year survival can exceed 90%. However, diagnoses that occur at stage 3 or stage 4 carry a five-year survival rate of less than half that figure. “We wanted to collect living cells from specific regions of the fallopian tube while leaving the surrounding tissue intact,” says Kripa Varanasi , PhD, senior author of the study and the Maher A Elmasri professor of mechanical engineering at MIT, in a release. “Once we have these living cells, there are many things we can do with them. We can use them for diagnostics, grow them into organoids, and build living models of disease. Ultimately, th

The five-year project evaluates MTBR-tau243 alongside p-tau217 to stage disease progression, predict clinical decline, and clarify ambiguous test results. Lund University has received a $19.4 million grant from the National Institutes of Health and the National Institute on Aging (NIH/NIA) to fund the clinical validation of a new blood-based biomarker test for Alzheimer’s disease. Running from 2026 to 2031, the five-year project aims to advance diagnostic accuracy and disease staging using the novel tau biomarker MTBR-tau243. Led by principal investigator Sebastian Palmqvist , associate professor of neuroscience and senior lecturer in neurology at Lund University and senior consultant at Skåne University Hospital, the research initiative represents the largest competitive grant Lund University has received from a US funder. The project will be conducted across patient cohorts in Sweden and the US in collaboration with researchers from Washington University in St. Louis, the University of Pennsylvania, and the University of Alabama. “The fact that an NIH grant of this calibre is being led from Lund University is strong international recognition of Sebastian Palmqvist and his colleagues in our Alzheimer’s research,” says Erik Renström, vice-chancellor of Lund University, in a release. “It is particularly encouraging since it demonstrates how cross-border collaboration also translates into tangible benefits for patients. The development of a new blood-based clinical test could m

Distributed via OpenLoop Health, the supplemental proteomic assay demonstrated 92% sensitivity and 93% specificity in clinical validation. Astrin Biosciences announced that its Certitude blood test for supplemental breast cancer screening is now available to eligible women across 48 states through a distribution partnership with telehealth platform OpenLoop Health. The non-imaging test is designed to detect early breast cancer signals from a standard blood draw, offering an additional screening option for individuals who face barriers to supplemental imaging. Nearly half of all women have dense breast tissue, a characteristic that increases breast cancer risk while diminishing the sensitivity of standard mammography. While supplemental imaging modalities exist, they can be costly, time-consuming, and inconsistently accessible depending on patient geography. “As a physician, I frequently discuss with patients who have dense breast tissue that while their mammogram is normal, dense tissue can make cancers more difficult to see on imaging,” says Dr Tanya Gupta, medical director at Astrin Biosciences, in a release. “Certitude provides another data point from a simple blood sample that may help patients and their physicians better understand their individual risk. Offering Certitude through telehealth has the potential to make this additional information more accessible to women and their physicians.” Proteomic Platform and Clinical Validation Certitude runs on Astrin’s deep prote

Funded by The Labcorp Charitable Foundation, the two-year Madison program partners with local free clinics to increase access to PSA testing, diagnostic follow-up, and specialty care. Project HOPE, funded by The Labcorp Charitable Foundation, has launched a two-year initiative in Madison, Wisconsin, to expand prostate cancer screening , diagnostic follow-up, care coordination, and treatment for men who are uninsured or face barriers to care. Early detection plays a critical role in clinical outcomes for prostate cancer , yet access disparities remain prevalent in the region. According to the Dane County Community Health Needs Assessment, prostate cancer mortality rates in Dane County exceed both state and national averages, with Black men experiencing the highest age-adjusted death rate. “This initiative is about strengthening local resources so more men can access the information, screening and follow-up care they need,” says Anna Tate, director of domestic programs at Project HOPE, in a release. “By supporting trusted community partners and creating clearer referral pathways, we can help reduce barriers for men who are uninsured or face challenges accessing care and make care easier to navigate.” Community Screening and Diagnostic Navigation The initiative is structured around a partnership between two local charitable providers: the Perry Family Free Clinic and the Specialty Care Free Clinic. Under the program, the Perry Family Free Clinic will partner with local barbers t

The collaboration will assess whether cell-of-origin signatures can track central nervous system cell damage and disease progression. Renew Biotechnologies has entered into a clinical development collaboration with Mayo Clinic to evaluate NeuroLens, a cell-free DNA (cfDNA)-based testing approach, in multiple sclerosis (MS) and related neuroimmunologic diseases. The study aims to address the clinical need for minimally invasive biomarkers capable of providing insight into active central nervous system (CNS) injury and tracking disease changes over time to inform individualized care. Building on Renew’s prior research in Alzheimer’s disease , Parkinson disease , and amyotrophic lateral sclerosis , the collaboration will evaluate cfDNA cell-of-origin signatures associated with cell death across characterized patient cohorts. The investigation will focus specifically on injury signatures tied to neurons, astrocytes, and oligodendroglial cells to determine how these molecular signals correlate with disease differentiation, phenotype, stage, severity, and progression. “Complex neurological diseases present clinical questions that require both strong molecular tools and deep clinical context,” says Chad Pollard, co-founder and CEO of Renew Biotechnologies, in a release. “Working with Mayo Clinic will help us explore new applications for NeuroLens, and provide insights as we seek to expand its potential to benefit patients across a broader range of neurological diseases.” Evaluating

A study across 231 clinical laboratories in 41 countries highlights major gaps in reference intervals, external quality assessment, and assay harmonization. A global survey of clinical laboratories has revealed substantial variations in how bone and mineral metabolism biomarkers are measured, interpreted, and reimbursed, according to findings from the International Osteoporosis Foundation (IOF) and the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC). The study, conducted by the IOF–IFCC Joint Committee on Bone Metabolism and published in Clinical Chemistry and Laboratory Medicine, evaluated self-reported practices from 231 laboratories across 41 countries. Bone status indices (BSIs) in blood tests provide key information regarding bone turnover and disease activity, serving as a complement to dual-energy X-ray absorptiometry in assessing osteoporosis and other metabolic bone disorders. However, the survey identified marked heterogeneity across analytical platforms, specimen types, reporting units, reference intervals, decision thresholds, external quality assessment (EQA) participation, and reimbursement models. “The survey’s findings reveal the extent of variation in laboratory practices that can affect BSI test results,” says Etienne Cavalier, chair representing IOF on the IOF–IFCC Joint Committee on Bone Metabolism and corresponding author, in a release. “These findings show that the lack of harmoni z ation is not merely a laboratory issue. Wh

Early operational data can show how referral networks, routine histopathology, ancillary testing, and turnaround time shape a new laboratory long before the service reaches maturity. By David Adler, MD, PhD, MBA; Aaron Perner, LLM; Karoline Reidenbach; Sven Perner, MD, PhD When a new pathology laboratory opens, some of its most important decisions have to be made before its future workload is fully visible. Staffing, histology capacity, immunohistochemistry workflows , reporting processes , referral relationships, and plans for advanced testing all have to be built while the service itself is still taking shape. That was the situation we encountered during the first months of routine operations at a newly established pathology institute, PATHORA Institute of Pathology & Tissue Medicine, in Reutlingen, Germany. To understand how the service was developing, we reviewed all 2,114 consecutive cases accessioned between Feb 9 and July 27, 2026. Rather than looking at one disease or specimen type, we examined the early operation as a whole: case volume, referral patterns, specimen mix, malignant diagnostic coding, ancillary testing , and turnaround time. The review showed that some patterns emerged quickly, while conventional administrative data underestimated other parts of the workload. Four lessons stood out. 1. More Referrers Did Not Mean a Different Case Mix The referral base expanded rapidly. During the observation period, the cumulative number of referring physicians increase

T he CE-marked kit simultaneously screens for spinal muscular atrophy, severe combined immunodeficiency, and sickle cell disease. TIB MOLBIOL, a subsidiary of Roche Diagnostics , has launched the LightMix Newborn TREC/SMN1/HBB kit, an in vitro diagnostic test for newborn screening in countries accepting the CE mark. The multiplex assay simultaneously screens for spinal muscular atrophy (SMA), severe combined immunodeficiency disease (SCID), and sickle cell disease. The IVDR-approved test provides academic and private hospital laboratories with a ready-to-use solution designed to integrate into existing laboratory workflows. The kit runs on established LightCycler systems, functioning as a first-tier screening tool to trigger immediate confirmatory testing and clinical intervention. “When a baby is born with a condition like SMA or SCID, every single day counts,” says Marcus Droege, CEO of TIB MOLBIOL, in a release. “Catching these diseases before symptoms appear isn’t just about early diagnosis; it’s the difference between a child thriving or facing severe, lifelong disability. By expanding our compliant newborn screening tools across Europe, we are helping laboratories transition to high-precision solutions that ensure no critical diagnosis is delayed.” Targeting Actionable Inherited Disorders Detecting these genetic conditions shortly after birth provides clinicians with actionable diagnostic data, enabling therapeutic intervention before irreversible physiological damage o

The blood test supports outpatient exclusion of deep vein thrombosis and pulmonary embolism and is designed for rapid laboratory STAT testing. Siemens Healthineers announced the global launch of its Innovance D-Dimer 2.0 assay, which has received US Food and Drug Administration 510(k) clearance and CE mark status. The diagnostic blood test is designed to assist clinicians in evaluating patients with suspected venous thromboembolism (VTE) , including deep vein thrombosis and pulmonary embolism . Blood clots affect approximately 10 million people worldwide each year and present significant clinical risks when they obstruct normal circulation or break loose to reach the heart, lungs, and brain. Rapid laboratory intervention is critical during these time-sensitive events to support optimal patient outcomes. “Minutes matter when clinicians are evaluating a patient for a serious blood clot,” says Martin Fuhrer, head of specialty laboratory solutions for diagnostics, Siemens Healthineers, in a release. “Our new D-dimer assay is designed to help laboratories deliver timely, high-quality results that underpin quicker, confident clinical decisions.” Clinical Applications and Clot Exclusion D-dimer testing helps clinicians assess individuals presenting with conditions or clinical factors that increase clotting activity, such as periods of immobilization, active cancer treatments, and pregnancy or the postpartum period. The Innovance D-Dimer 2.0 assay is indicated for the exclusion of de

The FDA-approved blood-based test expands colorectal cancer screening options for average-risk adults 45 and older and is covered by Medicare for eligible beneficiaries. Abbott has commercially launched SimpleScreen CRC in the US, an FDA-approved blood-based colorectal cancer (CRC) screening test for average-risk adults aged 45 and older. Developed and manufactured by Freenome and commercialized exclusively by Abbott, the test joins the stool-based Cologuard Plus test in the company’s CRC screening portfolio. Colorectal cancer represents the second-leading cause of cancer-related mortality in the US, with an estimated 60 million eligible individuals remaining unscreened. While the American Cancer Society (ACS) recommends stool-based tests and direct visual examinations as preferred screening options, clinical guidelines recommend blood-based screening for eligible adults who decline or fail to complete those preferred methods. SimpleScreen CRC is designed to serve as an alternative pathway for this unscreened population. “We still see too many eligible patients who remain unscreened. Expanding the ways patients can participate in screening gives clinicians another opportunity to address those barriers,” says Folasade May , MD, PhD, MPhil, director of quality in digestive diseases at UCLA Health and co-founder and board member of the Association of Black Gastroenterologists and Hepatologists, in a release. “For someone who has declined or does not complete preferred approaches