FDA Hepatitis Update

On June 20, 2013, FDA approved the first genotyping assay for Hepatitis C (HCV).
The Abbott RealTime HCV Genotype II is an in vitro reverse transcription-polymerase chain reaction (RT-PCR) assay for the identification of hepatitis C virus genotypes 1, 1a, 1b, and 2-5 in plasma or serum from individuals chronically infected with HCV. In other words, it is a laboratory test that can determine certain genetic types of HCV, providing information about what type a person is carrying.
The particular genome of an HCV infection is important, together with other clinical factors, in helping determine the appropriate type of therapy for patients with chronic HCV infections because the various HCV genotypes respond differently to available drug therapies.
The test extracts genetic material from inside HCV viruses in the patient's blood, amplifies the extracted genetic material to facilitate the differentiation process of the unique genotypes, and uses fluorescence to detect the amplified signal for each genotype in the laboratory.
The assay is intended for use as an aid in the management of HCV-infected individuals and in guiding the selection of therapeutic treatment indicated for the above listed genotypes in patients who are chronically infected with HCV who are being considered for antiviral treatment, and are positive for HCV RNA.
The Abbott RealTime HCV Genotype II assay is not for screening blood, plasma, serum or tissue donors for HCV.
Richard Klein
Office of Health and Constituent Affairs
Food and Drug Administration

Kimberly Struble
Division of Antiviral Products
Food and Drug Administration

Steve Morin
Office of Health and Constituent Affairs
Food and Drug Administration