HEPATITIS C RNA PANEL SHOULD BE DEVELOPED TO TEST NEW ASSAYS, PANEL SAYS; DCLD DEVELOPING GUIDANCE ON VARIOUS HEPATITIS A, B, C TESTS AND INDICATIONS
This article was originally published in The Gray Sheet
Executive Summary
FDA should develop a panel of hepatitis C virus RNA specimens to challenge new qualitative HCV RNA assays, the agency's Microbiology Devices Panel recommended at its Feb. 12 meeting in Gaithersburg, Maryland. The group was convened to assist FDA's Center for Devices and Radiological Health in efforts to develop a guidance that will prescribe clinical study guidelines for hepatitis A, B, or C tests for diagnosis and/or monitoring indications.
You may also be interested in...
Hepatitis C Draft Guidance Cites Utility Of Unapproved HCV-RNA Tests
Clinical trials of hybridization assays for monitoring hepatitis C viral RNA may use other unapproved HCV-RNA assays to corroborate test results, provided supporting data is submitted, FDA indicates in a recently released draft guidance.
Mustang Bio Enters Race For CAR-T In Autoimmune Disease
The biotech company’s CEO talked to Scrip about plans to bring the CD20-targeting CAR-T MB-106 into an investigator-sponsored Phase I trial later this year.