Interleukin Genetics announced that it has reached an agreement with the U.S. Food and Drug Administration (FDA) that clarifies the agency's regulatory approach toward its PerioPredict genetic test for periodontic disease.
In November 2015, the FDA's Office of In Vitro Diagnostics and Radiological Health (OIR) sent an untitled letter to Interleukin Genetics questioning the company's FDA clearance for several of the company's genetic tests, including its PerioPredict test. Specifically, FDA personnel said they were unable to find clearance numbers for the tests.
But Interleukin officials met with OIR personnel in February and subsequently clarified the regulatory status of the products, the company said. PerioPredict can continued to be marketed under the company's existing approach because it is a laboratory-developed test (LDT) that is subject to FDA enforcement discretion, and it can be marketing without prior marketing authorization.
"We are pleased with the collaborative nature of our interactions with the FDA on evaluating each of our commercial tests," stated Mark Carbeau, CEO of Interleukin Genetics. "The clarification of our lead product PerioPredict as an LDT reinforces our commitment to provide testing through a licensed dental or medical professional."
