FDA Approves Danaher Unit's Rapid Test for Hepatitis C

By Paul Ziobro

The Food and Drug Administration on Thursday granted marketing approval to Danaher's Cepheid unit for a rapid test for hepatitis C.

The approval is for Cepheid's Xpert HCV test and GeneXpert Xpress System, which the company said is the first test of the hepatitis C virus that can be used at certified point-of-care settings, such as certain use disorder treatment facilities, correctional facilities, syringe service programs, doctor's offices and urgent care clinics.

Instead of requiring a sample to be sent to a central lab, the test detects the virus's RNA and delivers results in less than about an hour using a blood sample from a fingertip.

Hepatitis C is a liver infection caused by a virus with the same name. It can either be a short-term illness or become a long-term chronic infection. According to estimates, more than 2.4 million people in the U.S. have hepatitis C, the company said.

Write to Paul Ziobro at paul.ziobro@wsj.com

(END) Dow Jones Newswires

June 27, 2024 15:56 ET (19:56 GMT)

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