FDA OKs U.S. Sale of 10-Minute HIV Test

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Mon Dec 29, 1:33 PM ET

 

WASHINGTON - The Food and Drug Administration (news - web sites) has approved a 10-minute HIV (news - web sites) test, the Irish company that makes the test said Monday.

 

Trinity Biotech PLC plans to market the test to government programs, physicians and hospitals for quick testing of health workers who accidentally prick their fingers with bloody needles. Traditional laboratory tests can take days or weeks to return results.

 

"It is a very significant market not being met at the moment," said Brendan Farrell, president of the Dublin-based company.

 

"There are over 800,000 needlestick injuries per year in U.S. hospitals. They need to know urgently if that patient was infected with HIV," Farrell said.

 

If a health care worker accidentally exposed to a patient's HIV-positive blood is treated with a combination of anti-HIV drugs within a few hours of exposure, the chance that the worker will become infected can be reduced.

 

The Uni-Gold Recombigen HIV test will cost doctors and hospitals $10 per test.

 

Trinity expects to sell 400,000 to 500,000 tests in the United States in 2004. The test is already sold in Africa and Asia.

 

Trinity also plans to target the roughly 200,000 pregnant women considered at high risk for passing infection to their unborn child. If the mother's HIV status is learned quickly, drugs can be administered to prevent her from passing the disease to the child during birth.

 

The test requires one drop of whole blood, serum or plasma. In the company's trials of more than 9,000 patient samples, the Trinity test detected 100 percent of the HIV positive specimens and was 99.7 percent accurate on the negative samples.

 

"It is every bit as accurate as lab-based tests," Farrell said.

 

The Trinity product will compete directly with OraSure Technologies Inc.'s OraQuick Rapid HIV-1 test approved in November 2002. OraSure's 20-minute test can be used only on whole blood, Farrell said, which will give his product an advantage in marketing to hospitals because they frequently test plasma and serum.

 

In June, the CDC said it would buy 250,000 OraQuick tests and training materials for 50 U.S. locations. The CDC's $2 million purchase was part of a larger HIV-prevention plan.

 

In Monday afternoon trading, shares of Trinity had soared $1.25, or 38 percent, to $4.53 on the Nasdaq Stock Market.

 

Also on the Nasdaq, shares of OraSure, of Bethlehem, Pa., had fallen 62 cents, or 7.2 percent, to $8.02.