U.S. Food and Drug Administration Grants Expedited Review To Roche for First PCR-Based Tests to Detect Hepatitis C Virus

PLEASANTON, Calif., April 17 /PRNewswire/ -- Roche Molecular Systems, Inc. announced today the U.S. Food and Drug Administration (FDA) has accepted its pre-market approval filing and has granted Roche expedited review for two hepatitis C tests designed to directly detect the presence of the hepatitis C virus (HCV) in the blood. Called the AMPLICOR(R) HCV Test, version 2.0, and the COBAS AMPLICOR(TM) HCV Test, version 2.0, the tests are the first qualitative RNA tests to be submitted to the FDA for review. The tests detect the presence of HCV RNA in serum whereby a positive result indicates current infection.

--Note the expedited review status is for QUALITATIVE not quantitative testing. the quantitative test which gives you a viral load number such as 50,000 copies/ml has not been FDA approved yet. This is important event because the FDA should expedite the quantitave test approvals as well--note from Jules Levin

According to the FDA, the expedited review status was granted due to the recognized public health problems of the disease associated with hepatitis C infection and the lack of standardized HCV RNA tests available to many laboratories. Upon approval, the AMPLICOR HCV Tests will be the first and only commercial qualitative nucleic acid tests available through hospitals and licensed laboratories.

An estimated four million Americans have HCV and 35,000 to 180,000 are newly infected each year. In the United States, the CDC estimates that hepatitis C is currently responsible for eight to ten thousand deaths per year and that number could increase to 38,000 annually by the year 2010, surpassing annual HIV/AIDS deaths.

Antibody tests currently used in the clinical setting only detect the presence of an immune response to the virus, providing only indirect evidence of the virus, not the actual virus itself. Roche's AMPLICOR HCV Tests utilize Noble Prize-winning Polymerase Chain Reaction (PCR) technology to directly detect the hepatitis C viral RNA. Furthermore, the AMPLICOR HCV Tests are the first HCV RNA assays to report the analytical sensitivity in International Units (IU/mL), as defined by the WHO International Standard for HCV RNA for Nucleic Acid Amplification Technology (NAT) Assays.