Abbott HCV KitAbbott, Abbott Park, Ill, introduces its fully automated RealTime HCV Genotype II test, the first FDA-approved hepatitis C virus (HCV) genotyping test for patients in the United States.

The test determines the specific type or strain (genotype) of the HCV virus present in the blood of an HCV-infected individual. Genotyping the HCV virus provides physicians with important information they can use to create a personalized, targeted diagnosis and treatment path to improve clinical outcomes.

“Hepatitis C is known as the silent killer as many of the symptoms go unnoticed,” says Carol Brosgart, MD, clinical professor of medicine, Division of Global Health, University of California, San Francisco, and HIV and viral hepatitis expert. “When patients are identified, determining their specific genotype is important to ensuring they receive the treatment that will prove to be most effective. The introduction of this test for broad use in the US is a significant advancement in helping to address an important public health issue,”

“The Abbott RealTime HCV Genotype II test adds yet another test to the Abbott portfolio for a full spectrum of hepatitis C testing—from ensuring blood supply safety and providing initial screening to enabling targeted diagnoses, identification of the right treatments, and the monitoring of response to therapies,” says John Coulter, vice president, Molecular Diagnostics, Abbott.

AbbottHepCClick here for more from Abbott on hepatitis C disease and testing facts.

Differentiating HCV strains by their genotypes offers the strongest predictor of sustained response to anti-viral drug therapy, and this information helps physicians decide which patients should be treated with various antiviral medications or combination therapies. For example, patients with genotype 1 infections have much lower response rates to interferon and ribavirin therapy, but a combination of newer antiviral agents (boceprevir or telaprevir), interferon and ribavirin is more effective for genotype 1 infections, according to studies published in the New England Journal of Medicine.1,2

The fully automated Abbott m2000 Real Time system offers clinical labs a total molecular testing solution for hepatitis with assays to measure exact viral loads for hepatitis B and hepatitis C, which are used for monitoring therapy success, and the HCV genotyping test to help assure that appropriate drug therapies are prescribed. The system speeds turnaround time for results, reduces technologists’ labor, and provides objective results. The system eliminates the subjective visual interpretations of test results.

According to the Centers for Disease Control and Prevention (CDC), more than 75% of adults with hepatitis C are Baby Boomers—born between 1945 and 1965—and most of them don’t know they are infected. In 2012, the CDC recommended that all Baby Boomers talk to their physician and get a one-time test for HCV since this group is five times more likely to have the virus. Once a patient is diagnosed with HCV, a physician would order a hepatitis C genotype test.

1. Poordad F et al. Boceprevir for untreated chronic HCV genotype 1 infection. N Engl J Med 2011 Mar 31; 364:1195

2. Bacon BR et al. Boceprevir for previously treated chronic HCV genotype 1 infection. N Engl J Med 2011 Mar 31; 364:1207

[Source: Abbott]