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.