Liz CareyDiagnostic TechnologiesSolvd Health CEO responds to harsh letter addressing FDA, CMSSolvd Health CEO Dr. Keri Donaldson responded to critics of his company's machine learning classifier clinical laboratory test that uses genotyping to aid healthcare providers in OUD assessments in adults prior to first-time opioid prescriptions.April 9, 2024Molecular DiagnosticsResearchers map protein biomarkers in sepsis fightSwedish researchers are mapping patterns of protein biomarkers in sepsis that could be useful for simple blood tests in the emergency department, according to research to be presented at ECCMID 2024.April 2, 2024Gene expressionMolecular diagnostic test study continues EET benefit assessmentA molecular oncology gene expression profiling (GEP) test for breast cancer biomarkers may influence extended endocrine therapy (EET) treatment decisions, according to an impact study.April 2, 2024Diagnostic TechnologiesHighlights of March 2024 LDT hearing with lawmakersThe VALID Act appeared to win hearts over the hammer of a forthcoming FDA final rule expected to drop heavy regulations on clinical laboratory developed tests (LDTs), a hearing of the House Subcommittee on Health revealed Thursday.March 22, 2024Pathology and AIPredictive AI model might aid early-stage NSCLC planningThe deep-learning AI model identified features that were not readily discernable to a trained pathologist.March 12, 2024Diagnostic TechnologiesFDA LDT oversight battle: Are we close?New directions in laboratory developed test (LDT) regulation appeared closer to final rule-making with the March 1 Office of Management and Budget (OMB) acceptance of the LDT final rule, pending regulatory review: a flurry of final rule-making thoughts.March 6, 2024ToxicologyQuest Diagnostics seeks to get a jump on PFAS testing in communitiesResearchers often use people’s blood PFAS levels as a proxy for exposure to perfluoroalkyl and polyfluoroalkyl substances, the "forever chemicals" found in certain products and the environment.February 13, 2024Business InsightsHologic receives FDA clearance for digital cytology scanner platform in U.S.Acknowledging human papillomavirus (HPV) as a causative agent for cervical cancer, the new system is designed to complement molecular testing for HPV with cotesting for cervical cancer.February 2, 2024Policy and RegulationPrecision medicine at tipping point with looming FDA LDT oversightFDA targets companion diagnostics (CDx) LDTs first. In addition, CAP and AdvaMedDx set clear expectations, and what to know about the FDA-CMS joint statement on FDA oversight.January 25, 2024ImmunoassaysGene therapy, companion diagnostic hit milestones for hemophilia ASix months after the FDA approved a one-time gene therapy for severe hemophilia A reportedly priced around $2.5 million per patient, the Center for Inherited Blood Disorders, a 340B treatment center in California, has announced the drug's first infusion.January 11, 2024Page 1 of 2Next PageTop StoriesFDA ClearancePillar Biosciences gets FDA approval for NGS solid tumor profiling testPillar Biosciences has announced that it has received approval from the U.S. Food and Drug Administration (FDA) for its OncoReveal CDx pan-cancer next-generation sequencing (NGS) test for general solid tumor profiling.ValidationImmunovia announces positive results for next-gen pancreatic cancer testCollaborationVertex to pay $25M upfront to scale cell manufacturing technologyMergers & AcquisitionsLabcorp buys Invitae portfolio for $239MSponsor ContentVisit our Molecular Diagnostics Community