LabPulse.com staff writersTrends and FinanceWeek in Review: Kronos Bio layoffs | Marburg virus test BARDA award | Google health AI platform releaseDecember 7, 2024Trends and FinanceAmgen to open second N.C. manufacturing facilityBiotech firm and drug manufacturer Amgen has announced a $1 billion expansion in North Carolina, with plans to establish a second manufacturing facility in the state.December 6, 2024Regulatory ApprovalWHO grants 1st prequalification to Cepheid TB testThe World Health Organization (WHO) has granted prequalification to Cepheid’s molecular diagnostic tuberculosis (TB) test.December 6, 2024Gene expressionVA to offer no-cost pharmacogenomic testing programThe U.S. Department of Veterans Affairs (VA) is offering no-cost pharmacogenomic testing to veterans enrolled at Veterans Integrated Service Network 4 facilities through the end of 2025.December 5, 2024SequencingGeneDx expands exome testing program for pediatric epilepsy patientsGeneDx has expanded its patient access program for pediatric epilepsy, which provides access to whole exome sequencing to qualifying pediatric patients.December 5, 2024Regulatory ApprovalFDA grants breakthrough device designation to DeepUll's bloodstream infection testDiagnostics developer DeepUll has received breakthrough device designation from the U.S. Food and Drug Administration (FDA) for its rapid bloodstream infection test.December 4, 2024ValidationOncocyte releases data on transplant rejection assayDiagnostics developer Oncocyte has announced study data showing that its monitoring assay for kidney transplant rejection significantly reduces the time to diagnosis.December 4, 2024CollaborationGilead, Tubulis to collaborate on ADC programGilead and biotech firm Tubulis have forged an exclusive option and license agreement to discover and develop an antibody-drug conjugate (ADC) against an undisclosed solid tumor target.December 3, 2024CollaborationCOUR Pharmaceuticals, Genentech sign agreement on autoimmune therapeutics developmentClinical-stage biotech firm COUR Pharmaceuticals announced a strategic partnership and licensing agreement with Genentech for the development and commercialization of COUR's nanoparticle treatments for an undisclosed autoimmune disorder.December 3, 2024Regulatory ApprovalDevyser gets IVDR approval for fetal RHD testDevyser Diagnostics has received In Vitro Diagnostic Regulation (IVDR) certification for its noninvasive fetal rhesus D (RHD) screening test.December 2, 2024Page 1 of 369Next PageTop StoriesBusiness InsightsTexas lab owner accused of $79M RPP fraud schemeThe DOJ implicated a Texas clinical laboratory owner and operator in respiratory pathogen panel testing fraud scheme.Research and DevelopmentRevvity broadens work in newborn testing for NHS EnglandRegulatory ApprovalRoche gets CE Mark for ovarian cancer CDx testSequencingAMP reviews pitfalls of NGS testing for SARS-CoV-2Sponsor ContentBody composition in patients treated with Ozempic