FDA Grants Breakthrough Device Designation To At-Home HPV Test Eligible for ACA Coverage

FDA granted breakthrough device designation Tuesday (May 7) for an at-home diagnostic test for high-risk human papillomavirus (HPV), an alternative to traditional in-office screening the company expects to be covered by insurance plans as preventative care. The move is significant because FDA speeds up its reviews of device applications with breakthrough designations. The at-home diagnostic test for HPV is manufactured by Teal Health and aims to increase patients’ timely access to regular HPV check-ups. Teal’s founder tells Inside Health Policy...