The FDA approved the first self-test for HIV in 2012, allowing more people to know their HIV status, but unfortunately, no company has applied for FDA clearance in the decade since.
In a paper published in Clinical Infectious Diseases, Stephany Ma, MPH, research program manager at the John Hopkins University School of Medicine, and colleagues highlighted the role and importance of these tests, as well as possibly reclassifying HIV self-tests from class III to class II moving forward.
Healio spoke with Ma to discuss what more is needed to bolster the market for these tests and what impact