FDA Approval for OraQuick HIV Test on Oral Fluid

OraSure Technologies, Inc. has announced that it has received U.S. Food and Drug Administration (FDA) approval of its OraQuick® Rapid HIV Antibody Test for use with oral fluid - Making the test the first and only rapid HIV test to be approved in the U.S. by the FDA for use with oral fluid.

The test was also approved for use on plasma samples.

The approval was announced by Secretary of Health and Human Services Tommy G. Thompson and officials from the FDA and Centers for Disease Control and Prevention (CDC) at a press conference in Washington, D.C.

'This oral test provides another important option for people who might be afraid of a blood test,' said HHS Secretary Tommy G. Thompson. 'It will improve care for these people and improve the public health as well.'

Secretary Thompson's sentiments were echoed by leaders both at home and abroad.

'The FDA's approval of additional claims for OraSure's new HIV test is a giant step forward in combating the global AIDS crisis. This simple test, which can use an oral fluid sample as opposed to a painful blood draw, gives new hope to those at risk of this dreaded disease,' said Senator Specter (R-PA). 'OraQuick® is a U.S. manufactured test that produces results in 20 minutes. The approval reaffirms this Administration's commitment to work in conjunction with private and government partners to fight the HIV virus. OraQuick® must be the new standard test for HIV testing, both in the U.S. and abroad.'