emergency use authorization
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.
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.
As diagnostics firms develop a new wave of COVID-19 tests using next-gen sequencing, TGen researchers are also adding CRISPR-based sample prep to their kit.
PathogenDx, Southern California Permanente Medical, Inova Diagnostics SARS-CoV-2 Tests Get FDA EUAs
PathogenDx and SCPMG's tests use RT-PCR technology, while Inova's test is for detecting IgG antibodies against the coronavirus.