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FDA Approves Abbott HCV Genotyping Test

NEW YORK (GenomeWeb News) – The US Food and Drug Administration has approved Abbott's hepatitis C virus genotyping test for marketing in the US, the company said today.

The Abbott RealTime HCV Genotype II, which Abbott is launching today, determines the specific type or strain of HCV present in the blood of an infected patient, allowing physicians to create a targeted diagnosis and treatment. The test differentiates genotypes 1, 1a, 1b, 2, 3, 4, and 5, FDA said separately.

The test runs on Abbott's m2000 platform.

The test is approved for individuals known to be chronically infected with HCV. It is not approved for use as a diagnostic test or for screening for the presence of HCV genetic materials in blood, blood products, or tissue donors, FDA said. The test has not been evaluated in newborns or pediatric patients or people with compromised immune systems.

"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," John Coulter, vice president of molecular diagnostics at Abbott, said in a statement. "Abbott continues to expand diagnostic testing options in the infectious disease area to benefit the healthcare system and enable doctors to improve patient care."

HCV is the most common chronic blood-borne infection in the US, with about 3.2 million people having a chronic HCV infection and 15,000 people dying from the virus annually, FDA said, citing statistics from the US Centers for Disease Control and Prevention. More than 75 percent of adults with HCV were born between 1945 and 1965, the so-called Baby Boomer generation, and most are unaware they have the disease. In 2012, CDC recommended they get tested for the virus.