Interleukin receives conditional approval to offer results of PerioPredict genetic risk test

Apr 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™ 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™ test is now available to dental providers and their patients in all 50 U.S. states.

The PerioPredict™ genetic test is collected by dentists during a routine exam or cleaning as a quick and painless procedure. PerioPredict™ 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™ test results provide essential information to the dental professional for assessing prevention and treatment options for their patients. PerioPredict™ 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™ 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™ 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™ patient samples since January 2014 and now will extend this test to patients in the State of New York."