An FDA advisory panel on Thursday recommended that twosecond-generation blood screening tests for the hepatitis Cvirus be approved for marketing.
Results of clinical trials of the new HCV tests were presented tothe Blood Products Advisory Committee by Ortho DiagnosticSystems, which will market one of the tests for Chiron Corp.(NASDAQ:CHIR), and by Abbott Laboratories, which makes thesecond test.
Chiron spokesman Larry Kurtz said the panel votedunanimously that the second-generation test was superior toits predecessor and that blood inventories at blood banks andhospitals be tested as soon as feasible after the new testbecomes available.
Chiron shares gained 38 cents to $50.13.
The new test uses three antigens: two envelope and one coreprotein. Chiron makes all three antigens for the Ortho test andtwo of the antigens for the Abbott test. The first-generationtest consists of the C100 envelope protein, which Chironmanufactured for both Ortho and Abbott.
The new test picks up 2.4 additional cases per 1,000 tests. Inthe United States, where 13 million units of donated wholeblood are screened annually, the new test will eliminate anadditional 60,000 units per year capable of infecting recipientswith HCV.
Based on certain timing issues, the Chiron/Ortho test mayreceive approval before the Abbott test, Kurtz said. Abbottofficials were unavailable for comment.
In addition to whole blood, about 8 million to 10 million unitsof plasma are tested annually, bringing the U.S. market to $70million to $80 million. Chiron/Ortho had about $160 million to$170 million in 1991 worldwide sales of the first-generationtest.
The FDA panel also recommended approval of Chiron's RIBA-HCV test, a supplemental test that would be used to counseldonors whose blood samples are repeatedly reactive in ascreening test. The Emeryville, Calif., company is developingthe test as an alternative to Western Blot tests.
The RIBA test has been sold in Europe since May. Includingresearch use sales in the United States, 1991 RIBA-HCV saleswere $10 million.
Chiron has an RIBA-HIV test at the FDA and is developing anHTLV-1 test.
-- Karen Bernstein BioWorld Staff
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