Liz CareyArtificial IntelligenceBacklog of unresolved medical diagnoses leads to new method for clinical exome reanalysisThe automated analysis improved the rate of accurate genetic diagnosis, doubling the number of solved cases as compared with benchmarked methods, across three distinct real-world cohorts, according to researchers.May 16, 2024Diagnostic TechnologiesFDA said no to proficiency testing for LDT qualityInferior tests can pass through proficiency testing, among ways PT falls short for test safety and effectiveness for intended purposes.May 2, 2024Policy and RegulationFDA releases LDT final ruleThe FDA announced its final rule on regulating laboratory developed tests (LDTs), also saying it will adopt targeted enforcement discretion for several categories of IVD LDTs manufactured by labs.April 29, 2024Diagnostic 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, 2024Page 1 of 3Next PageTop StoriesFDA ClearanceAmgen gets FDA approval for small cell lung cancer therapyAmgen announced on Thursday that the U.S. Food and Drug Administration (FDA) has approved its therapy tarlatamab, to be marketed under the name Imdelltra, for the treatment of extensive-stage small cell lung cancer (ES-SCLC).Artificial IntelligenceBacklog of unresolved medical diagnoses leads to new method for clinical exome reanalysisStockT2 Biosystems to sell $8M in stock in private placementFDA Warning LetterFDA issues warning for Cue Health COVID-19 testsSponsor ContentVisit our Molecular Diagnostics Community