Healio

FDA clears first ‘rapid diagnostic’ hepatitis C RNA test for point-of-care settings

Please provide your email address to receive an email when new articles are posted on . The FDA granted marketing authorization for Cepheid’s Xpert HCV test and GeneXpert Xpress System, the first ...
FOX31 Denver

FDA Permits Marketing of First Point-of-Care Hepatitis C RNA Test

Test Enables Single-Visit Testing and Treatment for Hepatitis C SILVER SPRING, Md., June 27, 2024 /PRNewswire/ -- Today, the U.S. Food and Drug Administration granted marketing authorization to ...
Morningstar

FDA Approves Danaher Unit's Rapid Test for Hepatitis C

The Food and Drug Administration on Thursday granted marketing approval to Danaher's Cepheid unit for a rapid test for hepatitis C. The approval is for Cepheid's Xpert HCV test and GeneXpert Xpress ...
Nasdaq

Cepheid Receives Expanded FDA Clearance with CLIA Waiver for Xpert® Xpress MVP

SUNNYVALE, Calif., Jan. 18, 2024 /PRNewswire/ -- Cepheid announced today that it has received FDA Clearance with Clinical Laboratory Improvement Amendments (CLIA) waiver for Xpert® Xpress MVP. This ...