Mesa Biotech FDA Classifies Mesa Biotech Recall of Accula SARS-CoV-2 Tests as Class I On April 6, Mesa recalled certain test kit lots because they had an increased risk of yielding false positive results due to contamination at the manufacturing facility. Pandemic Pushes Handheld qPCR Devices Closer to Commercialization Premium Miniaturized sample-to-answer devices in development hint at an evolving molecular diagnostics landscape but launch timelines for these platforms remain unclear. FDA Posts Info on Impact of SARS-CoV-2 Mutations on Test Effectiveness The FDA identified molecular tests from Mesa Biotech, Applied DNA Sciences, Thermo Fisher Scientific, and Cepheid that could be affected by certain mutations. Thermo Fisher Scientific to Acquire Mesa Biotech for Up to $550M The firm sells a rapid, point-of-care, PCR platform for infectious disease diagnostics, including SARS-CoV-2, influenza, respiratory syncytial virus, and strep A. FDA Issues Alert About Potential False Negative Test Results From SARS-CoV-2 Mutations The agency identified three tests potentially impacted by known mutations, and said it will continue to monitor authorized assays. Dec 9, 2020 Mesa Biotech Receives 510(k) Clearance, CLIA Waiver for Strep A Molecular Point-of-Care Test Nov 6, 2020 Mesa Biotech Awarded $13M in BARDA Funding for Coronavirus, Flu Combo Test Jul 31, 2020 NIH Awards $249M to Seven Firms for Rapid Acceleration of COVID-19 Diagnostics Apr 24, 2020 People in the News: Megan Bailey, Maureen Cronin, Ronald Park, Ingo Chakravarty, More Apr 1, 2020 Despite Potential, Experts Debate Whether Decentralized MDx for Coronavirus Can Flatten Curve Mar 24, 2020 Mesa Biotech COVID-19 Test Receives FDA Emergency Use Authorization Mar 18, 2020 Mesa Biotech Point-of-Care Coronavirus Test Development Receives $561,330 From BARDA Mar 12, 2020 Mesa Biotech Prepping Handheld Coronavirus Molecular Diagnostic System for EUA Premium Aug 5, 2019 Molecular Testing for Flu Catching up, But Still Lags Far Behind Use of Rapid Immunoassays Premium Nov 27, 2018 Mesa Biotech Respiratory Tract Infection Test Gets FDA Clearance, CLIA Waiver Nov 13, 2018 Mesa Biotech RSV Test Wins CE Mark Breaking News Guardant Health Files Motions to Dismiss, Change Venue in Illumina Patent Lawsuit In Brief This Week: SQI Diagnostics, T2 Biosystems, Enhanc3D, QuidelOrtho, More Illumina, Precision Health Research Singapore Partner for 100K Genomes Population Study 23andMe Fiscal Q4 Revenues Increase 14 Percent Local Coverage Determinations Roundup: Castle Bio, SkylineDx Ancient Genome Sequence Provides Look at Ancestry for Individual Who Perished at Pompeii The Scan Billion-Dollar Diversity Initiative The Howard Hughes Medical Institute is now accepting applications for its new $1.5 billion initiative to boost the diversity of the scientific workforce. Biotech Co-Founder Arrested A co-founder of a Los Angeles-based biotech company has been arrested in connection with a murder-for-hire scheme, according to Endpoint News. Return of the Tasmanian Tiger The Washington Post reports that a team in Australia is working to bring the thylacine back from extinction. Nature Papers on Genome of Individual From Pompeii, CircRNA Study Best Practices, More In Nature this week: first sequenced genome of a person from Pompeii, best practice guidelines for circRNA studies, and more.