Cepheid Receives FDA Clearance for Xpert® GI Panel to Support Broad Detection of Gastrointestinal Pathogens

Cepheid announced today that it has received FDA clearance for Xpert GI Panel, a multiplex PCR test designed to provide fast ...
360Dx

Cepheid Enters Rapid Syndromic Testing Space With FDA Clearance of GI Panel

The Danaher subsidiary aims to meet clinician needs for flexibility with a range of test size options for its vast installed base.
6abc News

FDA authorizes 1st COVID-19 antigen test, which produces results within minutes

The Food and Drug Administration has authorized emergency use of the first antigen coronavirus test, which produces results within minutes and is relatively cheap to make, according to the agency. The ...
abc13

FDA authorizes first breath test to detect COVID-19

WASHINGTON -- The US Food and Drug Administration has granted emergency use authorization to the first Covid-19 test that spots chemical compounds associated with the coronavirus in breath, the agency ...
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 ...
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 ...
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 ...
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 ...