Four companies receive FDA warning letters for unapproved HIV test kits
The U.S. Food and Drug Administration has issued warning letters to four direct-to-consumer disease testing companies for selling unauthorized blood collection kits for HIV diagnosis.
The companies receiving the letters are as follows:
- Genetrace (based in Washington)
- Genovate (based in Singapore)
- Germaphobix (based in Florida)
- ProDx Health (based in California)
According to the letters published by the FDA this week, all four companies have been selling HIV serological diagnostic dried blood spot card self-collection kits without marketing authorization in violation of the Federal Food, Drug, and Cosmetic Act. The FDA previously notified three of these companies that their HIV DBS card self-collection kits were not considered LDTs.
The FDA indicated, “Without appropriate testing, data review, and marketing authorization, there is a lack of assurance of the safety and effectiveness of your HIV DBS card self-collection kit. Self-collection raises several issues of importance, including, for example, whether the user can safely and properly collect the specimen, if the sample has been properly shipped, and if there is adequate stability of the specimen given the time lapse between collection and testing and the potential impact of shipping conditions. We also note that there is an FDA-approved over-the-counter HIV test that can help meet the needs of individuals who wish to test themselves at home or who are unable to access other testing options.”
The four companies were given 15 business days to respond to the FDA's concerns. "Failure to adequately address this matter may result in regulatory action being initiated by the FDA without further notice," the warning letters stated. "These actions include, but are not limited to, seizure, injunction, and civil money penalties.”
