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FDA Approves First Genotyping Test for Hepatitis C

FRIDAY, June 21 (HealthDay News) -- A new test to help doctors identify the genotype of a person's hepatitis C infection has been approved by the U.S. Food and Drug Administration.

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 U.S. Centers for Disease Control and Prevention. 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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