United Biomedical Inc. (UBI) announced Friday that an FDApanel recommended for approval the company's screening testfor the hepatitis C virus in donated blood.
UBI of Hauppauge, N.Y., bases the test on an enzymeimmunoassay to the NS-5 antigen of hepatitis C. This virus isresponsible for most of the non-A, non-B hepatitis cases amongpatients receiving blood transfusions.
The FDA's Blood Products Advisory Committee unanimouslyvoted to recommend approval of the test, which receivedsupport from the American Association of Blood Banks, theAmerican Red Cross, the Council of Community Blood Centersand the American Blood Resources Association.
UBI conducted comparison tests for FDA indicating that the testdetects 0.15 percent more potentially infectious units of bloodthan currently approved tests, said company spokeswomanRosanne Boyle.
When the UBI test indicated a reaction to its synthetic peptide,the presence of hepatitis C RNA in the plasma in question wasconfirmed with polymerase chain reaction amplification, shesaid.
Although contracting hepatitis C depends on a number offactors, including the number of transfusions a patient receives,the additional reactions generated by the UBI test wouldaccount for some 375,000 units of potentially infectious bloodamong the 25 million units donated annually in the U.S.
UBI plans to manufacture the test in Hauppauge. OrganonTeknika Corp., a U.S. subsidiary of Akzo, would handle U.S.distribution. The company's kit was approved in Japan earlierthis month, where it will be distributed by KyokutoPharmaceutical Industrial Co. Inc. under the trade nameSynpep.
UBI received a U.S. patent in April 1992 for the application ofits synthetic hepatitis C peptides in detection, diagnosis andprevention of hepatitis C infection.
Chiron Corp. of Emeryville, Calif., has a second-generationrecombinant immunoblot diagnostic for hepatitis C, which wasapproved in March 1992 and is marketed by Ortho.
-- Nancy Garcia Associate Editor
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