Roche Gets FDA Approval for Expanded Use of Hepatitis C Test

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."

Doctors who treat patients diagnosed with HCV typically monitor the viral load to help determine the best approach to treatment. Roche’s assay, called the COBAS AmpliPrep/COBAS TaqMan HCV Test, v2.0, was already approved and in use to measure how much virus is in a patient’s blood, according to the news release from Roche Diagnostics, a company that is part of Roche, the global biotech giant based in Basel, Switzerland.

This recent FDA decision permits Roche to also market the test as a diagnostic tool to confirm active hepatitis infection. The company said that the expanded indication can save time with decisions about treatment and help improve patient care.

The in vitro nucleic acid amplification test detects and quantifies HCV RNA genotypes 1 to 6 in human EDTA plasma or serum, according to the release. It is designed for use on Roche’s automated molecular diagnostics system that has an established platform for viral load monitoring of multiple infectious diseases.

The assay also has approval as a viral load test in the European Union, Mike Weist of Roche Diagnostics USA said in an e-mail. This new approval by the FDA for use of the test as an aid in diagnosis is unique to the U.S. for this test.

Roche makes several molecular tests that are approved both in the US and other countries for detection of HCV infection, Weist said.