Assay from Bayer HealthCare determines hepatitis C viral load
FDA approval for HCV assay
Leverkusen - The Diagnostics Division of Bayer HealthCare in Tarrytown, N.Y., USA, has received approval from the American food and Drug Administration (FDA) for a diagnostic test to determine the viral load in the blood of patients infected with hepatitis C. This is the only assay approved by the FDA for the quantitative determination of the viral burden. The assay has already been approved in Europe and Canada under the name Versant® HCV RNA 3.0 Assay (bDNA).
An estimated 170 million people worldwide are infected with the hepatitis C virus. Only a fraction of these people have been diagnosed and are being treated. Hepatitis C viruses can cause a liver infection that takes a chronic course in 50 percent of patients. This results in complications such as cirrhosis of the liver, liver cancer and liver failure. The level of hepatitis C virus in the patient's blood needs to be determined exactly in order to gauge the response to therapy.
"Bayer HealthCare is the only molecular diagnostics company that supplies two FDA-approved HCV RNA assays plus an HCV genotyping assay," commented Dr. Peter Knüppel, Head of the Nucleic Acid Diagnostics Group at Bayer HealthCare Diagnostics. "We are moving into a leading-edge position in the global market with this HCV product line."
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