Earlier this month, the FDA announced its approval of the first over-the-counter, rapid HIV test for at-home use. The test, OraSure's OraQuick In-Home HIV Test, allows users to test their own saliva for the presence of anti-HIV antibodies, using a rapid test strip that provides a result in 20-40 minutes.
The decision to approve this test was a controversial one, given the many questions surrounding at-home testing and the ~3-month window period that exists between HIV transmission and the development of anti-HIV antibodies. However, following the recommendation of its panel, the FDA decided that the benefits of at-home HIV testing outweighed the risks. In particular, this decision was largely motivated by the fact that nearly 20% of the 1.2 million people living with HIV in the United States are unaware of their status (see the CDC's fact sheet). By increasing access to HIV testing, it is hoped that this test will empower more people to know their HIV status so they can get the treatment they need and help prevent the spread of the virus.
This approval represents a breakthrough not only for the fight against HIV, but also for at-home testing in general. Although the FDA has approved many over-the-counter tests for at-home use in the past--including tests for pregnancy, glucose/diabetes monitoring, and drugs of abuse--this OraQuick In-Home HIV Test represents the first ever approved test for an infectious disease. As a developer of point-of-care diagnostics, this approval is extremely exciting, as it sets a precedent for the approval of at-home diagnostic tests. Now the question is, which test will be next??