By Diagnostics World Staff
March 24, 2026 | Verily Life Sciences and Samsung Electronics America enter a collaboration; PathAI announces that the U.S. Food and Drug Administration has granted Breakthrough Device Designation to PathAssist Derm; LinusBio announces that ClearStrand-ASD is now available for children up to age 10; and more.
Verily Life Sciences and Samsung Electronics America announced a collaboration that will bring together Samsung’s Galaxy Watch 8 with Verily’s precision health platform, Pre, to provide an integrated solution for generating evidence and monitoring real-world populations. Through this collaboration, Verily will fully integrate sensor data from the Samsung Galaxy Watch and make it accessible in its Viewpoint Evidence solution, which is built on the Verily Pre platform and enables research sponsors to run real-world studies with re-contactable participant cohorts. The partnership aims to accelerate research for life sciences and government customers by combining advanced health analytics with consumer-grade wearable data. Press release.
PathAI announced that the U.S. Food and Drug Administration has granted Breakthrough Device Designation to PathAssist Derm, designed to analyze digital pathology whole slide images of skin lesions and aid pathologists in their review. By leveraging advanced AI technology to support case assessment and workflow prioritization, PathAssist Derm is designed to help pathologists manage rising caseloads while maintaining diagnostic rigor. Press release.
Illumina and Nashville Biosciences announced two advancements in scale and depth of the Alliance for Genomic Discovery. With the addition of Regeneron Genetics Center (RGC) as the tenth member, the Alliance can expand the core dataset to 312,000 whole genomes. The Alliance also announced a new initiative: a dataset of 50,000 additional whole genomes with paired proteomic data generated using Illumina Protein Prep. GSK is among the first participants in this multiomic expansion. Press release.
Illumina also entered a strategic collaboration with Veritas Genetics Powered By Fuze Health to form a consortium that aims to bring preventive genomics into everyday healthcare through health insurance plans in the U.S. and under other global markets, setting a new standard for proactive health management. By combining clinical-grade sequencing, advanced informatics, and member-ready reporting, the collaboration supports an integrated data ecosystem to advance research, drug discovery, and clinical trial optimization. Press release.
MODAG launched PD DETECT. With the world’s first CE-certified test kit for Parkinson’s disease, the company is making innovative Seed Amplification Assay technology broadly accessible as a standardized procedure for specialized diagnostic laboratories and hospitals for the first time. Developed in cooperation with the AESKU.GROUP, the kit contains all necessary components to precisely identify Parkinson’s patients at the molecular level with a sensitivity of 97.8% and a specificity of 100%. MODAG aims to decentralize diagnostics, make them broadly available, and establish biological certainty rather than clinical probability. Press release.
LinusBio’s ClearStrand-ASD test is now available for children up to age 10. This broadens the test’s previously validated use beyond children under 48 months, making it the only objective autism rule-out test that spans from infancy through childhood. The expansion is supported by data from a global study of 1,697 participants, which has been submitted for publication in a peer-reviewed journal. The test launched last year after it was first announced in 2024. Press release.
Endometrics has been named the first-place winner of the NIH RADx Tech ACT ENDO Challenge, a national innovation competition designed to accelerate the development of new diagnostic technologies for endometriosis. The RADx Tech ACT ENDO Challenge, led by NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development and National Institute of Biomedical Imaging and Bioengineering, aims to accelerate the development of innovative non-invasive technologies to improve diagnosis of endometriosis. Press release.
The U.S. Food and Drug Administration has granted Breakthrough Device Designation to MeMed’s BV Flex, a test designed to accurately distinguish between bacterial and viral infections based on the body's immune response. Using a few drops of capillary blood, the test measures multiple immune proteins and applies machine-learning algorithms to generate a clinically actionable score in 15 minutes. Running on the MeMed Key platform, the test is designed for simplicity and intended, pending regulatory clearance, for use across hospitals, as well as CLIA-waived and decentralized care settings. Press release.
Xpedite Diagnostics commercially launched SwiftXtractor SL, the company’s first benchtop instrument for automated nucleic acid extraction from large sample volumes. The system accepts inputs from 200 µL up to 40 mL and delivers purified DNA and RNA in eluates as low as 50 µL, fully automated, in a single run, using standard laboratory tubes. SwiftXtractor SL is built around two complementary Xpedite technologies: SwiftX capture technology, which concentrates target cells, viruses, and microorganisms from large sample volumes using functionalized microparticles. SwiftX reverse purification chemistry, which selectively removes inhibitors and matrix components while nucleic acids remain in solution. The instrument automates the complete workflow, from cell and virus capture and lysis through purification and elution, with minimal hands-on time. Press release.
QIAGEN announced that the U.S. Food and Drug Administration has cleared the use of all QIAstat-Dx Gastrointestinal (GI) Panels on the QIAstat-Dx Rise automated syndromic testing system. With this approval, laboratories can run both QIAstat-Dx Respiratory and QIAstat-Dx GI panels on QIAstat-Dx Rise, the high-throughput version of the QIAstat-Dx system. Both versions support comprehensive syndromic testing with panels designed to detect multiple pathogens associated with similar symptoms in a single test, as well as targeted Mini panels that focus on a defined group of pathogens. Press release.
Genomenon announced a strategic sponsorship from Amicus Therapeutics to accelerate awareness, diagnosis, and research for Fabry disease. Through this collaboration, Genomenon produced literature-derived real-world evidence by applying fit-for-purpose AI and expert review to curate and classify variants in the GLA gene. The resulting variant evidence has been made freely available to the global clinical and research community through the Mastermind Genomic Intelligence Platform and submitted to ClinVar, the widely used public archive of human genetic variants hosted by the National Center for Biotechnology Information. Press release.
Caris Life Sciences launched a novel, proprietary Caris AI Insights signature for pancreatic cancer included in the Caris Molecular Tumor Board Report. The Caris Molecular Tumor Board Report is an innovative tumor profiling report that provides an additional tumor biology resource and is available upon request with no additional tissue sampling required when ordering MI Cancer Seek. Caris researchers are building next-generation multimodal models that accelerate biomarker discovery, enhance therapeutic decision-making, and support the development of more personalized cancer treatments. Press release.
numares has published a new analysis in Frontiers in Medicine highlighting its urinary metabolite constellation as the first biomarker test to show reliable diagnostic accuracy for detecting acute kidney transplant rejection during the critical first 14 days after transplantation in recipients of living donor kidneys. The study, “Diagnosis of Early Kidney Allograft Rejection: Influencing Factors in Metabolite‑Based Urine Analysis”, confirms that while many biomarker platforms struggle in the immediate post‑transplant phase, the metabolite constellation developed and validated by numares performs with full diagnostic strength right from day one in living-donor recipients. Press release.
Novigenix SA has launched Novigenix AI, a new precision medicine company dedicated to transforming therapy development through AI-powered immune intelligence. The new AI spin-out separates Novigenix's colorectal cancer (CRC) screening business from its rapidly growing AI-driven biopharma and precision medicine platform, allowing each entity to pursue focused go-to-market strategies, tailored capital structures, and distinct partnership pathways. Novigenix SA will continue advancing its CRC screening portfolio, including the Colox and ColoxNGS assays, distributed through Diagnosuite and clinical laboratory partners. Novigenix AI will exclusively commercialize the LITOSeek platform for biopharma, biotech, and precision medicine clinical applications globally. Press release.
Lucent Diagnostics, a brand of Quanterix Corporation, entered a partnership with Life Line Screening. Through the partnership, Life Line Screening will offer Lucent’s non-invasive blood-based biomarker test nationally, with programs in Florida, California, and Texas already underway. This partnership supports the goals of both organizations to provide non-invasive, easily accessible testing in the general public. With this expansion, they aim to bring accessible and convenient blood tests for early identification of Alzheimer’s disease and help primary care physicians facilitate early intervention and proactive lifestyle management. Press release.
Vocxi Health has partnered with Forj Medical to transform its MyBreathPrint device from a desktop prototype into a compact, handheld diagnostic platform designed for real-world use. The collaboration advanced the device’s performance and manufacturability, positioning it to revolutionize early disease detection through a simple, noninvasive breath test. MyBreathPrint uses graphene-based nano sensors and machine learning based algorithms to detect volatile organic compounds produced by the body in a person’s breath that correspond with specific diseases, including lung cancer, the world’s leading cause of cancer death. Vocxi partnered with Forj Medical to translate its breakthrough science into a manufacturable, market-ready device. Press release.
Thermo Fisher Scientific launched the TacroType Pharmacogenetic Test, a new laboratory developed test designed to help inform clinicians on dosing tacrolimus, a commonly prescribed immunosuppressive drug for transplant recipients to lower the risk of rejection. The company’s new TacroType Pharmacogenetic Test provides genetic insights that can help clinicians better understand how an individual patient is likely to metabolize tacrolimus — supporting more informed dosing decisions from the start and helping reduce the trial-and-error approach that many patients experience. Using a simple buccal swab sample, the test identifies a patient’s CYP3A5 genotype, which influences how quickly tacrolimus is metabolized and how a patient may respond to therapy. Press release.
Ovation.io and PrecisionLife announced the results of the first phase of their collaboration to develop drug-response biomarkers to quantitively predict the efficacy, safety and tolerability of glucagon-like peptide-1 receptor agonist (GLP-1) therapies, and the extension of their partnership. Using Ovation’s longitudinal clinical and omics datasets and PrecisionLife’s AI-driven combinatorial analytics platform, the partners identified underlying genetic drivers of GLP-1 efficacy to predict and stratify strong and weak responders within a large real-world population. The insights provide a better understanding of the genetic and biological drivers of GLP-1 responses and provide new biomarkers for drug development, refine patient enrollment in clinical trials, and potentially underpin a payor-facing test to inform reimbursement policy for these widely prescribed drugs based on a patient’s potential to tolerate and respond to a specific therapy. Press release.