OraSure initiates patient enrolment for HIV test study

OraSure Technologies has initiated patient enrolment for final phase of clinical studies for United States Food and Drug Administration (FDA) approval of the company's OraQuick Rapid HIV-1/2 test for sale in the over-the-counter (OTC) market.

The FDA had granted an investigational device exemption (IDE) for the home HIV test, which allowed OraSure to begin the final phase of the study.

During the unobserved user study, individuals will conduct unsupervised oral fluid self-testing using the investigational OTC version of the OraQuick Advance Rapid HIV-1/2 test.

OraSure also reported that the FDA has extended the product expiration dating to 24 months for its OraQuick Advance Rapid HIV-1/2 test which is currently available in the professional market.