FDA Approves Use of Roche’s Hepatitis C Virus RNA Test to Detect Active Infection

FDA Approves Use of Roche’s Hepatitis C Virus RNA Test to Detect Active Infection

Roche has announced its hepatitis C virus (HCV) quantitative ribonucleic acid (RNA) test has received approval from the U.S. Food and Drug Administration (FDA) to be used as an aid in diagnosing HCV infection in specific patient groups.

Results from the test — COBAS AmpliPrep/ COBAS TaqMan HCV Test, v2.0 — may now be used to confirm active HCV infections. Its use as a measure of viral load in a patient’s blood is already approved by the FDA. The expanded use of the diagnostic test will help physicians more quickly determine best treatment options and improve patient care, Roche said in a press release.

The COBAS HCV is the first to quantitative HCV RNA test approved for use as a diagnostic aid for active HCV infection. The test is an in vitro nucleic acid amplification assessment to detect and quantify HCV RNA genotypes 1 to 6 in human EDTA plasma/serum. It can be used to determine the likelihood of sustained virologic response (SVR) early during a course of antiviral therapy and to determine 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,” said Alan Wright, MD, MPH, Roche Diagnostics’ CMO. “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 polymerase chain reaction (PCR) assay is meant to be used in the management of chronic HCV, together with other lab markers of infection, as a diagnostic aid for individuals with HCV antibody evidence of infection, with or without liver disease, and individuals at risk of infection with antibody evidence. HCV RNA detection suggests that the virus is replicating and an individual has an active infection.

The World Health Organization (WHO) estimates that almost 200 million people are currently infected with HCV. About 170 million carry the virus chronically, and many are unaware of their infection. The Centers for Disease Control and Prevention reports five million U.S. citizens are living with hepatitis C, a disease that can lead to cirrhosis, liver failure, and hepatocellular carcinoma.

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