is starting studies on a rapid HIV test kit for use at home.
The company intends to determine the impact of environmental and common household factors on the performance of its OraQuick test through a number of tests, some of which have already begun, and others that are expected to begin shortly.
OraSure will seek Food and Drug Administration approval for the kit's over-the-counter use in the U.S.
"In addition to these laboratory-based stress studies, additional clinical studies are planned under amendments to an Investigational Device Exemption that we previously filed with the FDA," said President and CEO Douglas A. Michels. "We look forward to continuing our work with the FDA and other members of the health care community to make a home use rapid HIV test available in the United States."
An investigational device exemption allows a company to use its device in safety and effectiveness studies to support premarket approval, a review status for devices intended to support or sustain human life.
OraSure's shares were up 1.9% to $8.15.