Roche Gets FDA Approval for Expanded Use of Hepatitis C Test

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Roche Gets FDA Approval for Expanded Use of Hepatitis C Test

A new test for hepatitis C has just been approved by the FDA.

The US Food and Drug Administration has granted Roche expanded use of the company’s RNA test for hepatitis, which will allow the assay to be used as a diagnostic tool to confirm active infection in certain populations, the Swiss pharmaceutical company announced.   Long-term infection of the hepatitis C virus can seriously damage the liver over time and lead to cirrhosis, liver failure, or cancer of the liver. Because the virus often lacks symptoms, health officials worldwide have launched campaigns to encourage testing for it among high-risk populations.

Testing for hepatitis C is typically a two-step process that begins with a blood test to screen for antibodies, which indicates whether a person has been exposed to the virus. If antibodies are present then a second polymerase chain reaction (PCR) test that identifies HCV RNA is run to determine if the infection is active.

“Hepatitis C can be a silent killer, but with several highly effective new antiviral drugs on the market, there is a very high cure rate,” Alan Wright, MD, MPH, chief medical officer at Roche Diagnostics said in a release. “That’s why the CDC recommends HCV testing for persons at risk for infection and for everyone born between 1945 and 1965. But a positive HCV antibody test alone does not indicate an active infection. So it’s critical for physicians to diagnose an active infection by detecting the presence of hepatitis C virus RNA.”

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