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OraSure submits Rapid HIV Test final application to FDA

OraSure Technologies, known for disease diagnostics and biological sample collection, has submitted the final application to the US Food and Drug Administration (FDA) for OraQuick Rapid HIV-1/2 test for sale in the US consumer or over-the-counter (OTC) market.

The last and third module of the application is backed by the findings from the final phase of clinical testing, which involved the use of the OraQuick Rapid HIV-1/2 test.

The test involved around 5,800 subjects across 20 sites in the US, resulting in the identification of more than 100 previously undiagnosed individuals with HIV.

The final phase of clinical testing consisted of a multi-visit, blinded, unobserved user study in which individuals conducted unsupervised oral fluid self-testing using an investigational OTC version of the OraQuick ADVANCE Rapid HIV-1/2 test.

On completion of the tests, the performance of the OraQuick HIV test in the unobserved OTC setting was compared with FDA-approved laboratory HIV test results.