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FDA Approves First Standardized Hepatitis C Virus Genotype Test


The U.S. Food and Drug Administration (FDA) this week approved a new standardized laboratory test -- dubbed the Abbott RealTime HCV Genotype II -- for determining genotypes and subtypes of hepatitis C virus (HCV).

Genotypic testing is increasingly important as studies indicate that new direct-acting antiviral agents work better or worse not only against different HCV genotypes, but also subtypes (e.g., 1b vs 1a).

Previously, genotyping was done by individual laboratories without standardization. The new test is run on the Abbott's automated m2000 platform, which is also used for HIV and hepatitis B testing.

"Hepatitis C is known as the silent killer as many of the symptoms go unnoticed. When patients are identified, determining their specific genotype is important to ensuring they receive the treatment that will prove to be most effective," Carol Brosgart from the University of California San Francisco stated in an Abbott press release. "The introduction of this test for broad use in the U.S. is a significant advancement in helping to address an important public health issue."

Below is an edited excerpt from a recent FDA advisory describing the new assay:

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.



R Klein, K Struble, and S Morin, Food and Drug Administration. FDA Hepatitis Update. June 20, 2013.

Abbott. Abbott Announces New Test to Help Doctors Determine Personalized Treatment Path for Patients with Hepatitis C. Press release. June 20, 2013.