Shrugging off complaints that it is hindering innovation, the FDA is looking into whether five companies are selling unapproved diagnostic tests.
In separate letters sent to Kalios Genetics, Harmonyx, DNA-Cardiocheck, DNA4Life and Interleukin Genetics, the agency expresses concern that these companies are using a direct-to-consumer marketing model for their laboratory developed tests, as they appear to meet the criteria of medical devices. None of the tests have been cleared by the FDA.
The letters were sent regarding the following tests:
Harmonyx and Kailos say they are in compliance with regulations and they will work with the agency to address its concerns. The other companies could not be reached for comment by press time.
The letters come as the FDA mulls over how it will regulate LDTs. Earlier this month, Jeffrey Shuren, head of the FDA’s Center for Devices and Radiological Health, told a congressional panel that final guidance is expected next year on how the agency will enforce the regulation of LDTs ().
“Some of the criticism has been that we are trying to stymie innovation or slow people down, but really we are not. We need to make sure these tests are safe and effective, and do exactly what they say they are going to do,” CDRH spokesman Eric Pahon tells IDDM.