OraSure gets first crack at US HIV self-testing market with FDA approval
This article was originally published in Clinica
Executive Summary
The FDA has approved OraSure Technologies' OraQuick In-Home HIV test, making it the first over-the-counter test for the virus in the US. The approval comes just two months after a panel convened by the agency voted unanimously that the benefits of the diagnostic outweighed the potential risk of inaccurate results (www.clinica.co.uk, 16 May 2012).