The Diagnostics Division of Bayer HealthCare LLC, a member of the Bayer Group has received premarket approval after expedited review from the U.S. Food and Drug Administration (FDA) for its Versant HCV RNA 3.0 Assay (bDNA), a predictive test that directly measures hepatitis C virus RNA levels in serum or plasma. The Versant HCV viral load assay is the first and only FDA-approved quantitative test to measure HCV viral load levels, and will aid physicians by guiding therapeutic decisions early in treatment.
Approximately 4 million people in the United States and 170 million people worldwide are infected with HCV. The level of viral load, or HCV RNA, in a patient's blood can identify, early in treatment, patients who may not respond to further therapy. Utilizing an accurate HCV RNA quantitative assay such as the Versant HCV viral load assay can help clinicians decide if therapy should be discontinued, thereby avoiding the unnecessary side effects of prolonged treatment.
"Current therapeutic recommendations rely on the accurate determination of HCV viral levels to assess a patient's potential response to treatment. This is evidenced by a 2 log(subscript 10) (100 fold or 99 per cent) reduction in viral load at week twelve of therapy," said Eugene R. Schiff, Director, Center for Liver Diseases, University of Miami School of Medicine. "Since this viral measurement is essential to the clinical decision to continue or discontinue therapy, a reliable result as generated by the Bayer HCV bDNA assay affords great confidence in patient care."
The Versant HCV viral load assay is intended as an aid in the management of HCV-infected patients undergoing antiviral therapy.