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Trinity Biotech Says FDA Approves 10-Minute HIV Test
Monday December 29, 5:52 am ET
By Otesa Middleton, Of DOW JONES NEWSWIRES
WASHINGTON (Dow Jones)--Trinity Biotech PLC (NasdaqSC:TRIB - News) said Monday the Food and Drug Administration (News - Websites) approved its 10-minute HIV test, the first product approved for testing blood serum, plasma and whole blood.
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The Uni-Gold Recombigen HIV test will cost doctors and hospitals $10 per test.
The company plans to market the test to government programs, physicians and hospitals for quickly testing health workers who accidentally prick their fingers with bloody needles. Traditional laboratory tests can take days or weeks to return results.
"It is every bit as accurate as lab-based tests," Brendan Farrell, president of the Dublin company, said of Uni-Gold.
Trinity expects to sell 400,000 to 500,000 tests in the U.S. in 2004, Farrell said. The test is already sold in Africa and Asia.
"We're selling about four million tests per year in Africa right now," Farrell said.
Trinity's test is also approved for use in the World Health Organization's HIV testing program in Africa, Farrell said.
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% of the HIV positive specimens and was 99.7% accurate on the negative samples.
Selling this rapid test to hospitals is a main market for Trinity.
"It is a very significant market not being met at the moment," Farrell said. " 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."
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 HIV positive can be reduced, Farrell said.
"They need to test that patient very quickly," he said.
Trinity also plans to target the roughly 200,000 pregnant women considered at high risk for passing infection to their unborn child. Again, 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.
Farrell said Trinity will also market to U.S. Centers for Disease Control and Prevention programs, which he estimates to be a $30 million potential market for the company.
The Trinity product will compete directly with OraSure Technologies Inc. (NasdaqNM:OSUR - News)'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.
-By Otesa Middleton, Dow Jones Newswires; 202-862-6654; Otesa.Middleton@dowjones.com
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