Home Access Health submits PMA application to FDA for home-use HIV test.
This article was originally published in The Tan Sheet
Executive Summary
HOME ACCESS HEALTH SUBMITS PMA APPLICATION TO FDA FOR HOME-USE HIV TEST and requests an expedited review, the Chicago-based start-up announced June 1. Home Access Health Corp., formerly known as Anonymous Test Services, said it filed the premarket approval application following the mid-March completion of multi-center Phase III clinical trials involving more than 1,200 subjects. Home Access Health's PMA for an over-the-counter HIV test is the third such filing, joining the Johnson & Johnson subsidiary Direct Access Diagnostics' Confide and ChemTrak's HIV-1 Home Check tests at FDA.