BioFire BioFire Dx Receives First FDA Marketing Clearance for SARS-CoV-2 Respiratory Panel The test is the first COVID-19 assay to transition from Emergency Use Authorization to a cleared regulatory status. SARS-CoV-2 Mutations Present Unexpected Opportunities, Challenges for MDx Developers Premium Some tests that detect multiple SARS-CoV-2 genes are serendipitously signaling new viral variants while still effectively detecting infections. BioMérieux Coronavirus Test Gets FDA OK for Use With Pooled Samples The test, developed by BioMérieux subsidiary BioFire Defense, first received Emergency Use Authorization from the US Food and Drug Administration in March. Multiplex PCR Panels for Joint Infections on the Horizon Premium BioFire has submitted a 39-target test to the US Food and Drug Administration. OpGen also has a test in development. BioMérieux Q3 Revenues Increase 21 Percent The firm saw 120 percent growth in the BioFire FilmArray product line driven by strong demand for a respiratory panel which can detect SARS-CoV-2. Oct 6, 2020 BioFire Diagnostics, UMass Medical Coronavirus Tests Get FDA Emergency Use Authorization Aug 12, 2020 Traveler's Diarrhea Among Soldiers Linked to Gut Microbiome Changes Jul 9, 2020 BioMérieux Reports 62 Percent BioFire FilmArray Sales Growth in Preliminary Q2 Release May 19, 2020 BioMérieux's BioFire Pneumonia Panel Could Improve Care, Find Secondary Infection in COVID-19 Cases Premium May 4, 2020 BioMérieux's BioFire SARS-CoV-2 Respiratory Panel Wins FDA Emergency Use Authorization Apr 16, 2020 BioMérieux Reports 22 Percent Q1 Revenue Growth, Withdraws Full-Year Guidance Mar 24, 2020 BioMérieux Rapid Coronavirus Test Gets FDA Emergency Use Authorization Mar 20, 2020 Commercial Coronavirus Test Developers Tweak Timelines, EUA Plans in Light of Loosened FDA Guidance Mar 5, 2020 Coronavirus Dx Emergency Use Authorizations Progressing Rapidly Despite Criticism Feb 26, 2020 BioMérieux Reports 11 Percent Revenue Growth in Q4 Feb 11, 2020 Qiagen Readying Updated Respiratory Panel for Emergency Coronavirus Testing Jan 14, 2020 BioMérieux Submits 43-Target BCID2 Test to FDA Apr 30, 2019 Study of Luminex GI Panel in Children Reveals Salmonella Detection Issue Premium Apr 24, 2019 BioMérieux Q1 Revenues Up 8 Percent Feb 27, 2019 BioMérieux Reports 10 Percent Revenue Growth in Q4 Feb 6, 2019 AstraZeneca Spinoff Entasis Inks Deal to Use BioFire Tests Jan 3, 2019 Diagnostic Stewardship Debate Over BioFire Meningitis-Encephalitis Panel Heats Up Premium Dec 27, 2018 BioFire Bloodstream Infection Test Has Little Effect on Clinician Prescribing Behavior, Mayo Study Finds Premium Dec 26, 2018 GenMark Fungal Blood Culture Test Clears FDA Nov 13, 2018 BioMérieux Pneumonia Panels Get FDA 510(k) Clearance, CE Mark 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.