Bayer Corporation, acting through its Business Group Diagnostics, announced that the U.S. Food and Drug Administration (FDA) has granted approval of Gen-Probe Incorporated's PreMarket Application (PMA) covering Bayer's Versant HCV RNA qualitative assay, a nucleic acid probe diagnostic assay for the qualitative detection of HCV RNA in patients infected with hepatitis C. VERSANT(R) HCV qualitative assay, which utilizes proprietary Transcription-Mediated Amplification (TMA) technology from Gen-Probe, is the most sensitive HCV molecular diagnostic test to receive approval from the FDA.
With its superior sensitivity, this diagnostic test permits more accurate detection of HCV infections, providing physicians with better information to make treatment and management decisions. The qualitative HCV assay, developed and manufactured by Gen-Probe, will now be marketed to clinical laboratories in the U.S. by Bayer Diagnostics under the brand name, Versant.
"Clinical studies have shown that the Bayer TMA assay is highly sensitive and reliable rendering it an essential tool in the clinical management of HCV-infected patients," stated Eugene R. Schiff, Center for Liver Diseases, University of Miami School of Medicine. Dr. Schiff is the lead investigator on a poster presented at the 53rd Annual Meeting of the American Association for the Study of Liver Disease (AASLD) in Boston. Data presented by Dr. Schiff at the meeting summarize the results of the clinical trials conducted as part of the FDA submission. "The data generated in the clinical trial of this assay confirm that this test is suited for use at critical decision points in the HCV therapeutic continuum, affording great confidence in patient care."
Recent advances in the treatment of patients with hepatitis C have led to the need for improved diagnostic tools and testing algorithms. Additionally, early detection allows for early intervention, which may improve the effectiveness of antiviral therapies for HCV. Utilizing the latest approved therapies, roughly 40-80% of patients on therapy can expect clearance of the virus from their systems. The therapeutic response rate is influenced by the HCV genotype. Successful treatment response is determined by utilizing a sensitive test to detect HCV RNA at the conclusion of therapy and upon follow-up testing six months post-treatment. A significant percentage of patients who have no detectable viral RNA after the usual course of treatment subsequently relapse and show detectable levels six months later. The Versant HCV TMA assay has been shown to be of value in identifying a greater number of those patients who continue to have HCV in their blood.
"FDA approval confirms the clinical value of the Versant HCV TMA assay," said Peter Knueppel, senior vice president of Nucleic Acid Diagnostics, Bayer Diagnostics. "Its sensitivity is unmatched, and as a result we are certain that the Versant HCV TMA assay will become an important tool that clinicians can rely on to fight this terrible disease."
Hepatitis, a general term that refers to inflammation of the liver, can be caused by viruses, bacteria, drugs (both prescription and abused substances), toxins, or excess alcohol intake. Hepatitis C (HCV) is a blood-borne viral infection of the liver spread primarily by direct contact with human blood. The major causes of HCV infection worldwide are use of unscreened blood transfusions, and re-use of needles and syringes that have not been adequately sterilized.
According to the Centers for Disease Control and Prevention (CDC), HCV infects almost 4 million people in the United States alone. The World Health Organization (WHO) estimates that there are more than 170 million chronic carriers worldwide and 3 to 4 million persons are newly infected each year. Only a fraction of persons infected with hepatitis C are diagnosed and treated with available medications.
Hepatitis C Virus is a blood-borne pathogen posing one of the greatest health threats in developing countries. According to the National Women's Health Resource Center, up to 85% of individuals infected with HCV develop chronic liver disease, which could lead to both cirrhosis and liver cancer. Studies indicate that HCV is transmitted through contaminated blood and blood products, other close personal contact, and intravenous drug use.