Interleukin Genetics Announces Clarification of Commercial Test Compliance

Interleukin Genetics Announces Clarification of Commercial Test Compliance

Interleukin and the U.S. Food and Drug Administration have reached alignment on compliance status of Interleukin’s genetic tests

WALTHAM, Mass., April 05, 2016 (GLOBE NEWSWIRE) — Interleukin Genetics, Inc. (OTCQB:ILIU), a life sciences company focused on developing and marketing proprietary genetic tests for chronic diseases and health-related conditions, today announced the results of discussions with the U.S. Food and Drug Administration (FDA) in response to an Untitled Letter issued by the FDA on November 4, 2015 and a meeting on February 3, 2016 with personnel within FDA’s Office of In Vitro Diagnostics and Radiological Health (OIR) to discuss Interleukin’s written response to OIR with respect to the Untitled Letter. Interleukin believes it has maintained a constructive relationship with the FDA over many years and is committed to maintaining regulatory compliance for all of its tests.

OIR personnel recently confirmed that PerioPredict^®, which identifies individuals at increased risk for severe periodontitis, is a laboratory developed test (LDT) currently subject to FDA enforcement discretion and may continue to be marketed without prior marketing authorization at this time. OIR personnel also acknowledged that the Company does not currently offer a test for osteoarthritis, about which the OIR had inquired in the Untitled Letter.

The Company’s Bone Health and Heart Health tests, which are part of the Inherent Health line of tests, will be transitioned from a direct-to-consumer (DTC) distribution channel to a distribution model under which a licensed healthcare provider orders tests and oversees any resulting change in care. Following further discussions with FDA personnel, these two tests will be available through Interleukin Genetics’ DTC retail channels until May 22, 2016, at which time they will no longer be available unless requested by an authorized healthcare provider. Any Heart Health and Bone Health tests purchased through retail channels prior to that date will be processed through September 19, 2016. After these dates, the tests will only be made available to and processed for a licensed healthcare provider. We continue discussions with the FDA to determine appropriate next steps, if any, for our Weight Management test.

“We are pleased with the collaborative nature of our interactions with the FDA on evaluating each of our commercial tests,” said Mark Carbeau, Chief Executive Officer 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. Limiting the availability of the Heart Health and Bone Health tests to the same professional model supports our current strategy to provide actionable genetic insights to healthcare professionals. We are working closely with our partners and customers to ensure a smooth transition and completion of the tests in our laboratory.”

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