Gen-Probe Blood Screening System Gets FDA OK
San Diego-based Gen-Probe Inc. said the Food and Drug Administration approved the company’s Procleix blood-screening system for HIV and hepatitis C.
Gen-Probe, a unit of Japanese drugmaker Chugai Pharmaceutical Co., which developed the test, said it will be marketed worldwide by Chiron Corp. of Emeryville.
Henry Nordhoff, president and CEO of Gen-Probe, said the approval allows the firm to charge the American Red Cross and blood centers that have been using the test for free. He estimated Chiron will charge $10 to $15 per donation.
Analysts estimate the test could generate $150 million to $200 million in sales for the company, Bloomberg News reported.
Nordhoff said the approval was expected.
Gen-Probe announced earlier it will become an independent publicly traded firm in July to avoid antitrust issues that could result from Chugai’s merger with the Japanese unit of Swiss drugmaker F. Hoffman-La Roche Ltd.
, Marion Webb