Interleukin Genetics, Inc. 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 the disease has a genetic tendency to overproduce chronic inflammation. The use of PerioPredict can help meet the need for improved surveillance and risk stratification of these patients, 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.
“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 Ginsburg, MD, PhD, a founding director of the Center for Applied Genomics & Precision Medicine and a professor at Duke University, and Jeffrey Fellows, PhD, from The Center for Health Research, Kaiser Permanente. Kenneth Kornman, DDS, PhD, 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. “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.”
PerioPredict is a 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. 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, Mass.
For more information, please visit www.PerioPredict.com.