Liz CareyPolicy 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, 2024CLIACMS final rule settles controversial proposalA year-end final rule from the Centers for Medicare and Medicaid Services (CMS) settled a contentious proposal to include nursing degrees in the qualifications for high-complexity testing personnel under CLIA of 1988 regulations.January 4, 2024LawsuitHeated legal battles continue in cell-free DNA testing marketClinical genetic testing manufacturer Natera announced another victory in its fight to stop other companies from capitalizing on cell-free DNA (cfDNA) testing that appears to infringe on its patents. More genetic testing patent disputes are pending.January 2, 2024Business InsightsTop 10 most read articles in 2023 at LabPulseLabPulse.com's top 10 most read articles in 2023 focused on three hot health topics: major cases of fraud and abuse and FDA activities.December 28, 2023Molecular DiagnosticsNew trend in clinical lab testing spurs AMP guidanceThis approach allows significant streamlining of clinical lab operations when multiple disease-focused analyses are offered and reduces the upfront analytical validation burden, according to the AMP report.December 21, 2023Parkinson'sTwo new directions in Parkinson’s testingTwo recent Parkinson’s announcements suggest a new biomarker test panel coming, as well as cell culture systems for studying Parkinson’s in the laboratory.December 11, 2023Business InsightsNationwide health innovation network drives specialty lab space growthSeeking to better compete with traditional tech hubs in California and Massachusetts, Texas builds momentum to accommodate more startup and established life sciences laboratories involved in cutting-edge medical research.November 2, 2023Policy and RegulationFDA offers glimpse of what to expect with LDTsHillebrenner reviews the phaseout of FDA's general enforcement discretion approach for LDTs, opportunities for special considerations, and resources for industry.October 31, 2023Regulatory GuidanceFDA to discuss phaseout enforcement discretion for LDTsIn relation to its proposed medical device rule targeting laboratory developed tests (LDTs), the U.S. Food and Drug Administration (FDA) will hold a webinar Tuesday, October 31, at 1 p.m. EST.October 26, 2023Previous PagePage 2 of 3Next PageTop StoriesPCRQiagen partners with FBI on forensics assayQiagen has announced a collaboration with the FBI to develop a new assay to improve DNA quantification for use in forensics and human identification.ImmunoassaysUniversity of Florida researchers develop CRISPR-based assay for HPV detectionFDA ClearanceGeneoscopy receives FDA approval for CRC screening testLawsuitGerman court rules patent invalid in 10x infringement suit against NanoStringSponsor ContentVisit our Molecular Diagnostics Community