FDA Amazon, Diabetomics Get FDA Emergency Use Authorizations for Coronavirus Tests The FDA granted EUA to Amazon subsidiary STS Lab Holdco for the Amazon Real-Time RT-PCR DTC Test and the Diabetomics CovAb SARS-CoV-2 Ab Test. Thermo Fisher Gets FDA Emergency Use Authorization for Pooled Sample SARS-CoV-2 Test Kit The RT-PCR-based kit is designed to detect SARS-CoV-2 nucleic acid in pooled samples containing up to five individual nasal swab specimens. FDA Grants Emergency Use Authorizations for SARS-CoV-2 Tests From Harvard, NowDiagnostics Harvard's RT-PCR-based test can be used with self-collected nasal samples, while NowDiagnostics' immunoassay can be used with fingerstick blood samples. FDA Approves Janssen's Rybrevant, Guardant360 CDx for EGFR Exon 20-Mutated NSCLC The agency approved amivantamab for non-small cell lung cancer patients harboring EGFR exon 20 mutations, as detected by Guardant Health's blood-based test. Phosphorus Diagnostics Gets FDA EUA for Direct-to-Consumer Coronavirus Test, Sample Collection Kit The saliva-based assay is a nonprescription version of the Phosphorous COVID-19 RT-qPCR Test, which received Emergency Use Authorization from the FDA last year. Apr 26, 2021 TGen, Jumpcode Genomics Marrying NGS, CRISPR to Build a Better COVID-19 Test Premium Apr 23, 2021 PathogenDx, Southern California Permanente Medical, Inova Diagnostics SARS-CoV-2 Tests Get FDA EUAs Apr 20, 2021 Abbott Q1 Diagnostics Revenues More Than Double on COVID-19 Testing Apr 20, 2021 FDA Issues EUAs for SARS-CoV-2 Tests From Synergy Diagnostic Laboratory, Celltrion Apr 19, 2021 LGC Biosearch Technologies Gets FDA Emergency Use Authorization for SARS-CoV-2 Test Apr 16, 2021 Color Health, Yale Get FDA Emergency Use Authorization for Coronavirus Sample Collection Kits Apr 15, 2021 FDA Grants EUAs for SARS-CoV-2 Tests From Clinical Enterprise, Qorvo Biotechnologies Apr 13, 2021 PerkinElmer Preliminary Q1 Revenues Grow 98 Percent; FDA Issues EUA for PCR COVID-19 Test Apr 13, 2021 FDA-Led Group Evaluates Performance of RUO Liquid Biopsy Assays to Inform Practice Guidelines Premium Apr 13, 2021 Thermo Fisher Scientific Gets FDA EUA for High-Throughput, Automated COVID-19 Test Kit Apr 12, 2021 Lucira Health Nabs OTC EUA for SARS-CoV-2 Test, Expects Q1 Revenues of up to $4.5M Apr 2, 2021 Allarity Therapeutics Seeks FDA Premarket Approval for Prediction Tool as CDx for Dovitinib Mar 31, 2021 Biocept Prepares for First FDA Foray With CSF Liquid Biopsy Brain Metastases Assay Premium Mar 31, 2021 Delfi Diagnostics Starts Prospective Lung Cancer Screening Trial Mar 31, 2021 Talis Biomedical 2020 Revenues Rise Sharply Mar 31, 2021 FDA Posts Info on Impact of SARS-CoV-2 Mutations on Test Effectiveness Mar 30, 2021 Binx Health Chlamydia and Gonorrhea Test CLIA Waived Mar 29, 2021 Amazon, NeuMoDx, Becton Dickinson Get FDA Emergency Use Authorizations for Coronavirus Tests Mar 24, 2021 Twist Bioscience, Biotia Nab FDA EUA for Hybridization-Based NGS SARS-CoV-2 Assay Mar 23, 2021 FDA Grants EUAs for Direct-to-Consumer Versions of Color Coronavirus Test, Sample Collection Kit Load More Breaking News BillionToOne Raises $55M in Series B Financing GeninCode to Launch Cardiovascular Disease Risk Tests in US With Eversana Top Five Articles on GenomeWeb Last Week: Illumina, Liquid Biopsy, Thermo Fisher Scientific, and More Becton Dickinson Sues Beckman Coulter Over Cell Analysis, Sorting IP Genecast to Evaluate Liquid Biopsy EGFR Mutation Test in Early-Stage Non-Small Cell Lung Cancer Celemics, Strand Life Sciences Partner on Integrated Platform for NGS Analysis The Scan Another Resignation According to the Wall Street Journal, a third advisory panel member has resigned following the US Food and Drug Administration's approval of an Alzheimer's disease drug. Novavax Finds Its Vaccine Effective Reuters reports Novavax's SARS-CoV-2 vaccine is more than 90 percent effective in preventing COVID-19. Can't Be Used The US Food and Drug Administration says millions of vaccine doses made at an embattled manufacturing facility cannot be used, the New York Times reports. PLOS Papers on Frozen Shoulder GWAS, Epstein-Barr Effects on Immune Cell Epigenetics, More In PLOS this week: genome-wide association study of frozen shoulder, epigenetic patterns of Epstein-Barr-infected B lymphocyte cells, and more.