First genotyping test approved for hep C

First genotyping test approved for hep C
First genotyping test approved for hep C

HealthDay News -- The FDA has approved a new test to help healthcare providers identify the genotype of a person's hepatitis C infection.

The Abbott RealTime HCV Genotype II can distinguish between genotypes 1, 1a, 1b, 2, 3, 4 and 5, using an infected person's blood sample. Knowing the virus's genotype can help doctors determine the best treatment, the agency said in a news release.

Hepatitis C is the most common chronic blood-borne infection in the United States, and the leading cause of liver transplant, the FDA said, citing the CDC. Some 3.2 million people are infected with the virus, and about 15,000 people die from the infection every year.

The new test is approved for people who are known to have the infection. It is not meant as a way to diagnose hepatitis C, or as a way to screen for the virus's presence in the blood, the FDA noted.

The test has not been evaluated in children or in people with compromised immune systems, the agency said. It is manufactured by Abbott Molecular Inc., based in Des Plaines, Ill.

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