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 ...
Morningstar

Visby Medical Receives Landmark FDA De Novo Authorization for First-Ever OTC PCR Test for Sexual Health

The Visby Medical Women's Sexual Health Test represents a significant milestone as the first-ever PCR (polymerase chain reaction) diagnostic device approved by the FDA for OTC home use for any ...
Monthly Prescribing Reference

FDA Clears OTC Test for Chlamydia, Gonorrhea and Trichomoniasis

Credit: Visby Medical. The approval was based on a clinical study that included 2203 females aged 14 years and older. The Food and Drug Administration (FDA) has cleared the Visby Medical Women’s ...
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 ...
Business Wire

Visby Engages Quest and Labcorp to Broaden Consumer Access to First At-Home, FDA-Authorized PCR Test for STIs

SAN JOSE, Calif.--(BUSINESS WIRE)--Today, Visby Medical announced two new relationships that will expand national access to the Visby Women’s Sexual Health Test, the first, at-home, FDA-authorized PCR ...
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. Submits First FDA 510(k) Application for Co-Dx PCR Pro Platform

The Company expects that the application for OTC clearance will shortly be followed by pursuit of POC clearance, with other tests in the pipeline to meet the needs of a global market SALT LAKE CITY, ...
MarketWatch

Visby Medical Receives Landmark FDA De Novo Authorization for First-Ever OTC PCR Test for Sexual Health

SAN JOSE, Calif., March 28, 2025 /PRNewswire/ -- Today, Visby Medical(TM), a leading innovator in medical diagnostics, announced that the U.S. Food and Drug Administration (FDA) has granted De Novo ...