United Biomedical Inc. researchers have developed a peptide-based hepatitis C virus (HCV) diagnostic that they say worksbetter than assays currently sold in the $100 million U.S.market.
Dr. Chang Yi Wang, scientific director at United Biomedical anddirector of a study reported in the May issue of Proceedings ofthe National Academy of Sciences, told BioWorld that the assayis more sensitive and specific than assays currently on themarket. It uses peptides from both HCV coat and non-structural proteins. The scientists report that the HCV coatpeptides detect infection earlier and with fewer false positivesthan do non-structural peptides alone.
The first HCV diagnostic, introduced by Chiron Corp. one yearago today, consists of a recombinant non-structural HCVantigen that identifies HCV antibodies in the blood. The assaywas designed to get into the marketplace quickly, said Chironspokesman Larry Kurtz and, he said, probably does not work aswell as the peptide-based assay.
He said Chiron has completed clinical testing of a second-generation diagnostic that detects 90 percent to 95 percent ofHCV cases with only 20 percent to 25 percent false positives. Itconsists of recombinant derived HCV core protein and two non-structural antigens. Chiron plans to file for Food and DrugAdministration approval within a few weeks, Kurtz said.
Wang said that United Biomedical's assay has just beenapproved in Europe and that the Lake Success, N.Y., company iscompleting U.S. clinical testing with the goal of having theproduct on the market by the end of the year.
Kurtz said that Chiron's patent position is quite strong andcomprehensive, although no patents have issued yet.
"United Biomedical Inc. respects valid claims of any issuedpatent," Wang said. She added that the privately held companyhas filed several applications of its own.
-- Carol Talkington Verser, Ph.D. Special to BioWorld
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