OraSure Rapid HIV-1 Screening Test Is Cleared for Wider Distribution

OraSure Technologies Inc. has secured approval from the US Food and Drug Administration (FDA) to distribute its rapid HIV-1 test to more than 100,000 sites nationwide, including physician offices and counseling centers, the US Department of Health Human Services (HHS) announced on Friday [1/31/03].

The HHS announcement was made just hours after OraSure Technologies said it applied for FDA approval to expand distribution of the test under the Clinical Laboratory Improvements Amendments of 1988, permitting such tests to be used under less stringent controls.

The FDA first approved the test in November for use in about 40,000 laboratories nationwide due its moderately complex nature. But at the time, HHS Secretary Tommy Thompson had urged the company to seek the waiver in order to expand the test's potential use.

In a release to announce the approval, Thompson touted the FDA action as a vital step forward for the Department's public health mission. "Without today's action, this test would be limited to use in laboratory settings where many high-risk people do not go for testing," Thompson said.

Bush Promotes Wide Use of Test

In remarks today about recently announced global and domestic AIDS initiatives, President Bush referred to the wider availability of the rapid HIV test. He said it would encourage more people to ascertain their HIV status.

"How can you treat if you don't test? How can you help if you don't know?" Bush said in a White House speech.

The OraSure screening test, an HIV antibody assay, provides the results in about 20 minutes. Based upon the clinical research results, the test is believed to have a sensitivity of 99.6% and specificity of 100%.

OraSure CEO Mike Gausling told Reuters Health that under the waiver virtually all physicians will be able to obtain the test. He added that the company believes it has sufficient manufacturing capacity to meet the near-term demand and would ramp-up its production as demand grows.

But Gausling did acknowledge that the quick turnaround took the company by surprise. "We are still stunned around here," he said.

02/03/03