WALTHAM, Mass.–(BUSINESS WIRE)–April 22, 2014– Interleukin Genetics, Inc. (OTCQB:ILIU) today announced it has received conditional approval from the New York State Department of Health to offer, process and report the results of the PerioPredict(TM) Genetic Risk Test for periodontal disease. The State of New York is the only U.S. state that requires an independent regulatory review process including technical validation with clinical utility for laboratory developed tests run within a CLIA certified laboratory. In addition, Lynn Doucette-Stamm, Ph.D., Vice President of Development and Clinical Operations has received her Certification of Qualification from the State of New York providing qualification as a Lab Director for Genetic Testing. As a result of New York State approval the PerioPredict(TM) test is now available to dental providers and their patients in all 50 U.S. states.
The PerioPredict(TM) genetic test is collected by dentists during a routine exam or cleaning as a quick and painless procedure. PerioPredict(TM) measures variations in genes for Interleukin-1 (IL-1), a key mediator of inflammation and identifies individuals who are at increased risk for moderate to severe periodontal disease. The PerioPredict(TM) test results provide essential information to the dental professional for assessing prevention and treatment options for their patients. PerioPredict(TM) is run solely in the Interleukin Genetics CLIA-certified lab in Waltham, MA and the genetic results are provided to the dental professionals to utilize to further evaluate and customize patient care in their practice. The New York State approval along with our scientific evidence validates the use of the PerioPredict test for risk assessment of moderate to severe periodontitis. The Company published comprehensive validation studies for PerioPredict(TM) in the Journal of Dental Research in June 2013 and the Journal of Periodontal Research in April 2014.
Lynn Doucette-Stamm has over 20 years of experience in the genomics and biotechnology industry with a proven track record of managing commercial product development and genetic service teams. She heads both the Interleukin Clinical Operations and Research and Development Teams. Dr. Doucette-Stamm was previously a member of the MIT-based international collaboration that identified the Huntington’s Disease gene as well as the international sequencing consortium for the Human Genome Project. The Certification of Qualification from the State of New York requires proven experience and background in the areas of genetic testing to be offered in a clinical testing environment. Dr. Doucette-Stamm’s qualification as a Laboratory Director further validates her level of expertise to oversee the genetic testing laboratory at Interleukin. In addition to overseeing the CLIA laboratory operations in general, Dr. Doucette-Stamm will now provide additional backup for Dr. Patricia Murphy, Laboratory Director, Interleukin Genetics.
“Securing the approval to offer the PerioPredict(TM) test in the State of New York is an important achievement for Interleukin and an essential step in our providing dental providers with access to this genetic information on their patients,” said Dr. Kenneth Kornman, Chief Executive Officer of Interleukin Genetics. “Our CLIA-certified lab, led by Dr. Doucette-Stamm, has been processing PerioPredict(TM) patient samples since January 2014 and now will extend this test to patients in the State of New York.”
Periodontitis is a chronic inflammatory disease initiated by specific bacteria that activate host mechanisms destroying the bone and connective tissues that support the teeth. Between 8% and 13% of the worldwide adult population exhibit severe generalized periodontitis, with many more having clinical signs of moderate disease. Individuals who have a history of periodontitis and have been appropriately treated require more preventive care to maintain health. Current treatments to prevent gum disease are good oral hygiene and a recommended two dental cleanings per year, even though there is little evidence to support multiple routine cleanings. The “Patient Stratification for Preventive Dental Care” study suggests that individuals who are at higher risk for periodontal disease may benefit from 3-4 cleanings per year while those at lower risk may need only one cleaning per year. The Company believes risk stratification of patients without a history of periodontitis may optimize preventative dental care to improve outcomes and reduce long-term oral healthcare expenses.
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 to prevent certain chronic conditions and manage their existing health and wellness through genetic-based insights with 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 partnerships with health and wellness companies, healthcare professionals and other distribution channels. Interleukin Genetics’ flagship products include its proprietary PerioPredict(TM) genetic risk panel for periodontal disease and tooth loss susceptibility sold through dentists, and the Inherent Health Weight Management Genetic Test that identifies the most effective diet and exercise program for an individual based on genetics. Interleukin Genetics is headquartered in Waltham, MA and operates an on-site, state-of-the-art DNA testing laboratory certified under the Clinical Laboratories Improvements Act (CLIA). For more information please visit www.ilgenetics.com.
Certain statements contained herein are “forward-looking” statements. 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 the Company’s annual report on Form 10-K for the year ended December 31, 2013 and other filings with the Securities and Exchange Commission. The Company disclaims any obligation or intention to update these forward-looking statements.