MedCity News

PCR Comes to the Home With FDA Authorization of Visby’s OTC Sexual Health Test

PCR is a mainstay in diagnostics, but whether a sample is collected at a clinic or at home, such tests require sending a sample to a lab and then waiting for results. A new FDA authorized ...
The Lethbridge Herald

Oral HIV self-test approved for sale, advocates say it’s key to elimination

An oral, at-home HIV test that delivers results in as little as 20 minutes and has been used in the U.S. for well over a ...
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 ...
Business Wire

Siemens Healthineers Announces FDA Emergency Use Authorization For CLINITEST® Rapid COVID-19 Antigen Self-Test

The CLINITEST Rapid COVID-19 Antigen Self-Test has received FDA EUA for unsupervised self-testing for the SARS-CoV-2 virus by individuals age 14 and older (or adult-collected samples from individuals ...
Morningstar

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

Consumers Now Have More Choices to Purchase the Visby Device Featuring 30-Minute, Lab-Quality Results Today, Visby Medical announced two new relationships that will expand national access to the Visby ...