Arizona Daily Star

GenoSensor Granted FDA Emergency Use Authorization for High Throughput COVID-19 RT-PCR Diagnostic for Use in U.S.

With a high sensitivity detection (single copy detection) when run according to its instructions for use in a qualified clinical lab, the GS™ COVID-19 RT-PCR test is one of the most sensitive tests ...

What’s the Point of PCR Tests Anymore?

Though they’re not perfect, at-home tests will detect infections about 80% of the time, according to the U.S. Food and Drug Administration. So is there any reason to get a PCR test anymore? Judging by ...
Business Wire

Minute Molecular’s DASH Point-of-Care COVID-19 Rapid PCR Test Gains FDA Emergency Use Authorization

EVANSTON, Ill.--(BUSINESS WIRE)--Minute Molecular Diagnostics today announced that the U.S. Food and Drug Administration (FDA) granted an Emergency Use Authorization (EUA) for its rapid DASH ...
Seeking Alpha

Co-Diagnostics, Inc. Completes Submission to FDA for Co-Dx PCR Pro

The Company's Emergency Use Authorization submission is for the new Co-Dx PCR Pro instrument and COVID-19 test kit, designed for point-of-care and at-home. The menu of tests in development for the ...
FOX8 Cleveland

Nuclein's DASH® SARS-CoV-2 & Flu A/B Test for Use on the DASH® Rapid PCR System Receives FDA 510(k) Clearance and CLIA Waiver with Key Support from CovarsaDx® Research Team

LOS ANGELES, Jan. 7, 2025 /PRNewswire/ -- CovarsaDx ®, a prominent Clinical Research Organization (CRO) renowned for its in vitro diagnostics (IVDs) and medical device expertise, announced today that ...