The Food and Drug Administration has given the green light tomarket Ortho Diagnostic Systems Inc.'s HCV 2.0 ELISA TestSystem for the hepatitis C virus, just one day after an advisorypanel recommended approval of the second-generationscreening test.
Ortho is marketing the test, which costs about $3.50, for ChironCorp. of Emeryville, Calif. Chiron (NASDAQ:CHIR) makes thethree antigens that comprise the test.
Test kits "went out the door in trucks today, and testing withthe second-generation system begins on Monday," said Chironspokesman Larry Kurtz. The new test will replace a single-antigen HCV test licensed by the FDA in May 1990.
The advisory panel last Thursday also recommended approvalof a competing test from Abbott Laboratories, but the FDAhasn't acted on that recommendation. Chiron manufactures twoof the three antigens in that test.
Hepatitis C is thought to be responsible for more than 90percent of transfusion-associated hepatitis worldwide.
Chiron shares rose 38 cents to $50.50.
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