510(k) 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. Luminex Nabs $11.3M From BARDA to Develop Test for SARS-CoV-2, Flu, RSV The firm said it intends to apply to obtain FDA Emergency Use Authorization and 510(k) clearance for a panel that detects respiratory targets in a single test. Roche Receives FDA Clearance for Cobas BKV Test for Use With Urine Samples The test was previously cleared by the FDA for use with ethylenediaminetetraacetic acid plasma samples to manage BK virus in transplant patients. Mesa Biotech Receives 510(k) Clearance, CLIA Waiver for Strep A Molecular Point-of-Care Test The firm said its test fits in the palm of a hand and delivers results in 30 minutes by detecting bacterial nucleic acid in throat, nasal, or nasopharyngeal swabs. OpGen Provides Additional Info to FDA on Antimicrobial Resistance Gene Panel The company first submitted for 510(k) clearance last year and has received two additional information requests from the agency. 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 Apr 30, 2019 InDevR Gets FDA 510(k) Clearance for Influenza Assay Apr 15, 2019 GenMark Diagnostics Obtains FDA Clearance for Gram-Negative Sepsis Panel Dec 20, 2018 GenMark Diagnostics Receives FDA Clearance for ePlex BCID Gram-Positive Panel Dec 20, 2018 Becton Dickinson Gets FDA Clearance for Enteric Viral Panel Load More Breaking News Pediatric Medulloblastoma Subgroups May Benefit from Lower-Dose Radiation Therapy Space Radiation Shows Limited Effects on Mammalian Sperm DNA, Fertility Bluestar Genomics Sues Former Consultant, Ludwig Institute for Cancer Research Over IP Ownership New Products Posted to GenomeWeb: 10x Genomics, Swift Biosciences, Agilent Technologies, More In Brief This Week: Quantum-Si, TGen, Yale, and More People in the News: New Appointments at Invitae, PGDx, Oxford Nanopore, PacBio, More The Scan Fertility Fraud Found Consumer genetic testing has uncovered cases of fertility fraud that are leading to lawsuits, according to USA Today. Ties Between Vigorous Exercise, ALS in Genetically At-Risk People Regular strenuous exercise could contribute to motor neuron disease development among those already at genetic risk, Sky News reports. Test Warning The Guardian writes that the US regulators have warned against using a rapid COVID-19 test that is a key part of mass testing in the UK. Science Papers Examine Feedback Mechanism Affecting Xist, Continuous Health Monitoring for Precision Medicine In Science this week: analysis of cis confinement of the X-inactive specific transcript, and more.