Gen-Probe Incorporated announced that the U.S. Food and Drug Administration (FDA) have granted approval of its PreMarket Application (PMA) for its Qualitative HCV Assay. Gen-Probe developed this amplified assay based on its proprietary Transcription-Mediated Amplification (TMA) technology. The Qualitative HCV Assay, which will be marketed by Bayer Corporation, Diagnostics Division, under the brand name Versant, is to be used by clinical laboratories to detect the presence of HCV in human plasma or serum in patients suspected to be actively infected with HCV or with evidence of the HCV infection.

"Among the approved assays for the detection of HCV RNA in blood, the VERSANT(R) HCV RNA Qualitative Assay is the most sensitive," stated Eugene R. Schiff, Center for Liver Diseases, University of Miami School of Medicine. Dr. Schiff was lead investigator on the poster presented at AASLD and was one of the lead investigators for the assay clinical trial.

"Gen-Probe developed this amplified assay based on our proprietary TMA technology, which is the same technology that is used in our FDA-licensed HIV-1/HCV assay for screening donated blood," said Henry L. Nordhoff, chairman, president and chief executive officer of Gen-Probe. "The approval of the Qualitative HCV Assay represents the introduction of TMA to the clinical virology market. With its exquisite sensitivity, the assay provides significant benefit to patients infected with HCV."

Under the terms of the Gen-Probe/Bayer agreement, the Versant HCV Qualitative Assay is currently distributed by Bayer in the following 11 countries: Japan, Canada, France, Switzerland, Spain, Italy, Germany, Belgium, Greece, the United Kingdom and the Netherlands.

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. According to the World Health Organization, approximately 170 million people are infected worldwide with HCV. Studies indicate that HCV is transmitted through contaminated blood and blood products, other close personal contact, and intravenous drug use.