Saying its saliva-based HIV test works properly, Bethlehem, Pa.-based OraSure Technologies Inc. said Wednesday that it would start shipping the tests early in November. The product launch was delayed after a clinical trial of the OraQuick Advance Rapid HIV-1/2 Antibody Test showed a higher rate of unconfirmed positive results than the company had found in its own clinical data.
The company conducted another study that mirrored the field use of the test, and reviewed more than 12,000 test readings. Results from that study, in addition to data from several independent studies, "clearly indicate that the test is operating within its specifications," the company said.
OraQuick Advance is the only Food and Drug Administration-approved rapid HIV test available that uses saliva, the company said. Analyst David Lewis of Thomas Weisel Partners said he believes the less invasive, user-friendly oral test will expand the existing public-health HIV-testing market of 3 million people by as much as 25 percent.