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 Institutional Review Board (IRB) approval for a clinical study to assess the impact of the Company’s PerioPredict Genetic Risk Test on dental patient engagement for more preventive dental care. The study will build on Interleukin Genetics’ evidence base in support of the medical and economic value of the PerioPredict genetic testing platform.
PerioPredict identifies individuals at increased risk for severe periodontitis because they have a genetic tendency to over-produce chronic inflammation, an underlying root cause of many chronic diseases. Dental care and periodontal treatment and maintenance provides a practical access point to significantly lower the systemic inflammatory burden. The use of PerioPredict can help meet the need for improved surveillance and risk stratification of these individuals, enabling personalization of treatment plans and improved outcomes.
The clinical study will evaluate dental patients who routinely visit their dentist once per year by choice, despite having insurance coverage for twice-per-year visits, to ascertain how knowing their increased risk for developing severe periodontal disease due to genetic tendency to overproduce inflammation might impact the frequency of preventive care visits for these patients. The practice-based clinical study will enroll 800 subjects from 20 to 30 general dentistry clinics. The study is expected to launch on May 1, 2016.
“Given the role of inflammation in many chronic diseases, PerioPredict test results may serve as a powerful motivator for an individual to engage and take action to increase preventative dental care, which has been associated with substantial reduction in the cost of managing several chronic diseases, including type 2 diabetes and coronary artery disease,” said Mark Carbeau, Chief Executive Officer of Interleukin Genetics. “We believe this study will provide further evidence in support of the clinical utility of PerioPredict, and are excited to be collaborating with such accomplished scientists from prominent, forward-thinking institutions in this effort.”
The study will be conducted by a team with broad expertise, including collaborators Geoffrey S. Ginsburg, M.D., Ph.D., a founding director of the Center for Applied Genomics & Precision Medicine and a professor of Medicine, Pathology and Biomedical Engineering, at Duke University, and Jeffrey L. Fellows, Ph.D., from The Center for Health Research, Kaiser Permanente – leading experts in the fields of genetic medicine and population health initiatives, respectively. Kenneth Kornman, D.D.S., Ph.D., Chief Scientific Officer of Interleukin, will serve as Principal Investigator.
“This study will help us determine how dental professionals can use genetic risk information provided by PerioPredict to positively impact patient behavior and ultimately, improve patient wellness outcomes as well as reduce their healthcare costs,” said Dr. Kornman, Chief Scientific Officer of Interleukin Genetics. “Dental offices provide a potentially powerful access point to reduce systemic inflammation. Our goal is to provide dental offices with additional practical tools they can utilize to enhance health in their at-risk patients and to add value to the dental practice.”
Periodontal disease is one of the most common chronic inflammatory diseases in developed countries, and better control of the condition has been shown to significantly lower the systemic inflammatory burden.
PerioPredict is an innovative, easy-to-use genetic test that identifies individuals with an increased risk for severe and progressive periodontitis, due to a life-long genetic predisposition to over-produce Interleukin-1 (IL-1), a key mediator of inflammation. Such individuals may benefit from enhanced dental care to prevent or treat periodontitis and thereby lower their systemic inflammatory burden. Targeted management of systemic inflammation has been shown to help manage several chronic diseases, including type 2 diabetes and coronary artery disease. The PerioPredict test is made available to employees in covered health plans under the supervision of a licensed dentist or physician, and the 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, and for informing lifestyle choices to facilitate wellness. Our tests provide information that is not otherwise available to empower individuals and their healthcare providers to manage their health and wellness through genetics-based insights and actionable guidance. Interleukin Genetics leverages its research, intellectual property, and genetic panel development expertise in inflammation and metabolism to identify individuals whose risk for certain chronic disease may be increased due to variants in one or more genes, which can enable a more targeted approach to the individual’s healthcare. 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 that identifies individuals at risk for severe periodontal disease and a life-long predisposition to overproduce inflammation, 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 statements related to the design and timing of the clinical study and that PerioPredict test results may serve as a powerful motivator for an individual to engage and take action to increase preventative dental care. 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.