510(k) Becton Dickinson High-Throughput MDx Module, Triplex STI Test Get FDA 510(k)Clearance Along with a sample prep module, the BD Cor MX module is capable of delivering as many as 1,000 sample results in 24 hours. 23andMe Gains FDA Clearance for Direct-to-Consumer Prostate Cancer Genetic Risk Test The firm is now authorized to sell a genetic health report on the HOXB13 marker that indicates risk for hereditary prostate cancer, its third DTC cancer risk report with 510(k) clearance. OpGen Receives FDA Clearance for AMR Panel, Prelim Q3 Revenues Up 9 Percent The firm's Acuitas AMR Gene Panel tests for 28 genetic AMR markers in isolated bacterial colonies from 26 different pathogens. NYU Langone Health Gets FDA Clearance for Solid Tumor Gene Sequencing Test The test uses next-generation sequencing to detect cancer-linked mutations in 607 genes to help guide patient treatment. FDA Clears Zymo Research Coronavirus Sample Collection Device Zymo Research previously received CE-IVD marking for the collection device, which enables the transport and storage of SARS-CoV-2 RNA at ambient temperatures. Feb 19, 2021 Luminex Nabs $11.3M From BARDA to Develop Test for SARS-CoV-2, Flu, RSV Feb 11, 2021 Roche Receives FDA Clearance for Cobas BKV Test for Use With Urine Samples Dec 9, 2020 Mesa Biotech Receives 510(k) Clearance, CLIA Waiver for Strep A Molecular Point-of-Care Test Oct 14, 2020 OpGen Provides Additional Info to FDA on Antimicrobial Resistance Gene Panel Sep 8, 2020 FDA Clears DiaSorin Test for Influenza, RSV Sep 8, 2020 Roche BK Virus Test Garners FDA Clearance Sep 1, 2020 Immunexpress, Biocartis to Roll Out Sepsis Test in Europe Ahead of Planned US Launch Premium Aug 18, 2020 23andMe Garners FDA Clearance for CYP2C19 PGx Test Report Apr 30, 2020 FDA Provides Second Clearance for Binx MDx Platform Apr 1, 2020 FDA Proposes Reclassification of HCV RNA, Antibody Tests Jan 31, 2020 Translational Software to Submit PGx Software Platform for 510(k) Clearance Premium Jan 8, 2020 Applied BioCode Receives FDA Clearance for Syndromic Respiratory Pathogen Panel Dec 20, 2019 FDA Clears Curetis Lower Respiratory Tract Infections Panel Dec 17, 2019 FDA Clears DiaSorin Molecular VZV Test Nov 19, 2019 Rheonix Submits MDx System, Triplex Sexually Transmitted Infections Test to FDA Nov 12, 2019 FDA Clears NantHealth Tumor-Normal Whole-Exome Test Oct 1, 2019 FDA Clears Luminex Aries MRSA Assay Sep 12, 2019 Applied BioCode Submits Respiratory Pathogen Panel to FDA Jun 12, 2019 FDA Clears Roche Extraction Platform For Use With Applied BioCode GI Pathogen Panel, System Jun 6, 2019 Akonni Bio Obtains FDA 510(k) Clearance for TruDiagnosis MDx System, PGx Test Load More Breaking News Agilent Technologies Fiscal Q2 Revenues Rise 5 Percent SARS-CoV-2 Genome Analysis Reveals Fitness-Enhancing Mutations Startup Incubator IndieBio, GP-Write Launch Initiative to Fund Genome Engineering Firms Precipio Receives CE-IVD Mark for Hematologic Cancer Panels Illumina Adds CDx Indication to European TruSight Oncology Test for NTRK Gene Fusion Detection BioMérieux Gets Health Canada Approval for Updated BioFire Blood Culture ID Panel The Scan Taking Stock of the Stockpile The US and European countries are evaluating their smallpox vaccine stockpiles as the number of monkeypox cases increases, the Washington Post reports. Vitamin D From Tomatoes According to Reuters, researchers in the UK have gene-edited tomatoes so their fruit contains vitamin D. Cause Not Yet Spotted NPR reports that a new study was unable to find a cause for persistent long COVID symptoms. PNAS Papers on Central African Hunter-Gatherers, Myopia Development, Ancient Microtia Allele In PNAS this week: population patterns among Central African hunter gatherers, effect of myopia-linked gene variant, and more.