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 ...

Breaking the PCR-Only Barrier: Dual 510(k) Clearance and CLIA-Waiver Establish FINDER as the First Molecular Point-of-Care Platform with Multifunctional Capabilities

Baebies announced FDA 510(k) clearance and CLIA-waiver approval for the FINDER(R) Flu A&B/SARS-CoV-2 Test, an ultra-rapid RT-PCR assay on the FINDER platform. This establishes FINDER as the first ...
Business Wire

QuidelOrtho Receives FDA 510(k) Clearance for Its QuickVue® COVID-19 Test

SAN DIEGO--(BUSINESS WIRE)--QuidelOrtho Corporation (Nasdaq: QDEL) (“QuidelOrtho" or the “Company”) has received U.S. Food and Drug Administration (“FDA”) 510(k) clearance for its QuickVue COVID-19 ...
Medscape

FDA Approves Genetic Test for KRAS Mutation in CRC Patients

July 6, 2012 — The US Food and Drug Administration (FDA) has approved the therascreen® KRAS RGQ PCR Kit to be sold as a companion diagnostic test for cetuximab (Erbitux). In addition, the FDA has ...
The Financial

Roche receives FDA CLIA waiver for flu A/B test for use on its cobas Liat PCR System

The FINANCIAL — Roche on September 22 announced that the U.S. Food and Drug Administration (FDA) has granted CLIA (Clinical Laboratory Improvement Amendments) waiver for the cobas Influenza A/B test ...
McKnight's Long-Term Care News

PALTmed calls on providers to stop using routine PCR urine tests for UTIs

An expert panel convened by the nation’s top post-acute care medical organization has recommended against the routine use of urine PCR tests to diagnose urinary tract infections. Such tests have ...
pix11

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 ...