Waltham, MA — 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.”
PerioPredict is an innovative, easy-to-use genetic test that identifies individuals with an increased risk for severe and progressive periodontitis. It is made available to employees in covered health plans under the supervision of a licensed dentist or physician. PerioPredict works by measuring variations in the genes for Interleukin-1 (IL-1), a key mediator of inflammation. PerioPredict is able to identify individuals at increased risk for more severe periodontal disease due to a life-long genetic predisposition to over-produce IL-1. Such individuals may benefit from enhanced dental care to prevent or treat periodontitis and thereby lower systemic inflammatory burden. The PerioPredict test results provide important information to dental professionals for assessing prevention and treatment options for their patients. The PerioPredict test is run solely in Interleukin’s CLIA-certified lab in Waltham, MA. For more information, please visit www.PerioPredict.com.
About Interleukin Genetics
Interleukin Genetics, Inc. (OTCQB: ILIU) develops and markets proprietary genetic tests for chronic diseases and health-related conditions. The products empower individuals and their healthcare providers to manage existing health and wellness through genetics-based insights and actionable guidance. Interleukin Genetics leverages its research, intellectual property, and genetic panel development expertise in metabolism and inflammation to facilitate the emerging personalized healthcare market. The company markets its tests through healthcare professionals, partnerships with health and wellness companies, and other distribution channels. Interleukin Genetics’ lead products include its proprietary PerioPredict genetic test for periodontal disease and its Inherent Health® line of genetic tests. Interleukin Genetics is headquartered in Waltham, MA and operates an on-site, state-of-the-art DNA testing laboratory certified under the Clinical Laboratory Improvements Amendments (CLIA). For more information, please visit www.ilgenetics.com.
Certain statements contained herein are “forward-looking” statements, including, but not limited to, statements that PerioPredict will continue to be subject to FDA enforcement discretion and may continue to be marketed without prior marketing authorization. Because such statements include risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause actual results to differ materially from those expressed or implied by such forward-looking statements include, but are not limited to, those risks and uncertainties described in Interleukin’s annual report on Form 10-K for the year ended December 31, 2015, and other filings with the Securities and Exchange Commission. Interleukin disclaims any obligation or intention to update these forward-looking statements