OraSure finishes FDA submission for HIV test
OraSure Technologies Inc. said Tuesday it has completed its submission of a potential over-the-counter HIV test to the Food and Drug Administration for approval.
The Bethlehem, Pa., company, which makes diagnostic kits to detect HIV and drug use, said it submitted the third and final phase of clinical testing on its OraQuick test to regulators.
That phase involved testing of 5,800 people around the country. OraSure said the testing led to the identification of more than 100 previously undiagnosed individuals with HIV. The company said there are about 1.2 million people in the United States with HIV, the virus that causes AIDS, and about 240,000 are unaware they have the virus.
The company will provide a toll-free call center that offers customer support and referral services around the clock.
OraSure started submitting data to the FDA in last year's third quarter. The company also makes the OraQuick Advance HIV test, which is used in hospitals and doctor's offices.