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 ...
Healio

FDA grants emergency use authorization to first mpox PCR home test

Please provide your email address to receive an email when new articles are posted on . Labcorp has received FDA emergency use authorization for its Mpox PCR Test Home Collection Kit. This test is now ...
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 ...
News Medical

CARB-X awards $1.8 million to Visby Medical to develop a portable rapid PCR test for gonorrhea

Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) will award up to US$1.8 million to biotechnology company, Visby Medical, to develop a portable rapid polymerase chain ...
Morningstar

Co-Diagnostics Initiates Clinical Evaluations for Upper Respiratory Multiplex Point-of-Care Test on Co-Dx™ PCR Platform to Support Submission to the U.S. FDA

SALT LAKE CITY, Nov. 18, 2025 /PRNewswire/ --Co-Diagnostics, Inc. (Nasdaq: CODX) (the "Company" or "Co-Dx"), a molecular diagnostics company with a unique, patented platform for the development of ...
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 ...