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FDA expands approval for HCV RNA test
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The FDA approved the use of a quantitative RNA test that aids in identifying hepatitis C virus infection in certain patient populations, according to a press release.
The Cobas AmpliPrep/Cobas TaqMan hepatitis C virus (HCV; Roche) test is the first to be approved for the detection of active infection. Previously, the test was approved for providing an accurate measurement of the viral load in a patient’s blood. It also has been used to predict the probability of sustained virologic response during early antiviral therapy and to assess the viral response to antiviral treatment.
“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 the 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.”
The dual-probe PCR assay is an in vitro nucleic acid amplification test that detects and quantifies HCV RNA genotypes 1 to 6 in plasma or serum samples. It is approved for the management of patients with chronic HCV in combination with clinical and laboratory markers of infection, as well as a diagnostic aid for patients with antibody evidence of HCV infection and liver disease, patients suspected to have active infection and patients at risk for HCV infection with antibodies to HCV, the release said.
According to WHO, 200 million people are affected by HCV worldwide, and approximately 170 million are chronic carriers of the virus, although most are unaware they are infected. The CDC estimates there are about 5 million people in the United States with HCV.