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 ...
WGHP

Cepheid Receives FDA Authorization with CLIA Waiver for Xpert® HCV

SUNNYVALE, Calif., June 27, 2024 /PRNewswire/ -- Cepheid announced today that it has received FDA De Novo marketing authorization and Clinical Laboratory Improvement Amendments (CLIA) Waiver approval ...
Monthly Prescribing Reference

FDA Clears Point-of-Care Test to Detect Hepatitis C Virus

Credit: Cepheid. The Xpert HCV test delivers results in about an hour. The Food and Drug Administration (FDA) has granted marketing authorization to Xpert ® HCV, a point-of-care hepatitis C virus (HCV ...
FierceBiotech

FDA clears its first fingerstick hepatitis C diagnostic, enabling test-to-treat approach

The FDA has greenlit its first point-of-care diagnostic test for hepatitis C, capable of using only a fingerstick blood sample, in a bid to quickly connect patients with antiviral drugs. “Despite the ...
MedPage Today

FDA OKs First Point-of-Care Test for Detecting Hep C in At-Risk Adults

The FDA on Thursday granted marketing authorization to the first point-of-care test for hepatitis C virus (HCV), enabling at-risk adults to be rapidly diagnosed and immediately linked to care if ...
Medical Xpress

Costs pose hurdle for promising new hepatitis C lab test

A new rapid test for hepatitis C could help identify many more patients who could be cured of the deadly disease, but its use may be limited unless insurers' reimbursement rises to cover its high cost ...