The FDA granted a product license to the hepatitis C virus (HCV)-specific diagnostic assay developed and manufactured by ChironCorp. and distributed by Ortho Diagnostics Systems Inc., a subsidiaryof Johnson & Johnson.
The test, called Chiron RIBA HCV 2.0 Strip Immunoblot Assay (SIA),is intended as an additional, more specific test for specimens foundto be reactive in HCV antibody screening procedures. Because thesupplemental assay provides more information than the currenttests, it will allow physicians to firmly establish the presence of HCV,which is important to ascertain prior to treatment.
Chiron (NASDAQ:CHIR) of Emeryville, Calif., and Ortho jointlydeveloped and licensed the first HCV screening test in the U.S. in May1990, followed by an improved, more sensitive test introduced inMarch 1992.
The hepatitis C virus (once known as non-A, non-B) is now known tobe the primary causative agent for the majority of hepatitis casesfollowing a blood transfusion. Of all known forms of hepatitis, HCVhas the greatest likelihood of advancing to chronic hepatitis and isthe major cause of serious liver disease such as cirrhosis andhepatocellular carcinoma.
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