WALTHAM, Mass., Dec. 7 Interleukin Genetics, Inc. (NYSE Amex: ILI) announced today it has received approval by the State of New York's Department of Health for the Company to sell in New York its PST Genetic Test that determines predisposition to severe periodontal disease in individuals. The test has been available in all other States in the U.S. However, through its Clinical Laboratory Evaluation Program (CLEP), New York monitors the accuracy and reliability of results of laboratory tests, including genetic tests, on specimens obtained within the state, setting one of the highest accreditation standards in the country for genetic testing companies.
Interleukin Genetics currently distributes its PST genetic test to dentists through a licensing agreement with OralDNA Labs, a subsidiary of Quest Diagnostics, Inc. This approval will further expand OralDNA Labs' reach to the dentist community with the PST test.
"We are pleased to have met New York's standard for both our laboratory practices and our PST test. This approval by New York further supports our commitment to provide genetic tests that offer strong clinical value," said Lewis H. Bender, CEO, Interleukin Genetics. "PST along with our Heart Health now both meet New York State's unique criteria."
The PST Genetic Test provides a means of assessing an individual's genetic risk for periodontal disease, the most common cause of tooth loss. PST is the only genetic test available that is capable of identifying which patients are at increased risk for developing severe periodontal disease and can provide dentists and hygienists with important clinical information about their patients. The test is especially useful in patients with early signs of periodontal disease, including recurrent gingivitis and early-to-moderate periodontitis to identify patients more likely to develop severe periodontitis and associated complications.
About Periodontal Disease
Periodontal (gum) diseases, including gingivitis and periodontitis, are bacterially-induced chronic inflammatory diseases. Periodontitis affects the gums and bone supporting the teeth and if untreated or improperly treated can lead to tooth loss. Periodontal disease can affect one tooth or several, and is classified as mild, moderate or severe, based on clinical and radiographic evidence of loss of tissues that support the teeth. About a third of adults will have at least three to four teeth affected with moderate periodontal disease. It is well established that individuals who are smokers, have diabetes, or have IL-1 gene variations are at increased risk for more severe and generalized periodontitis. Periodontitis is usually first diagnosed by a dentist. In the U.S. there are over 160,000 dentists who frequently perform diagnostic (86 percent) and preventive (79 percent) procedures. The U.S. dental market is valued at $70 to $96 billion annually, with the average patient spending about $560 per year, over half of this on diagnostic and preventive procedures. Of the 128 million patients who visit a dentist each year, half are in the age range most appropriate for PST risk assessment. Additional information about periodontal disease may be found on the American Academy of Periodontology website at www.perio.org.
About PST Genetic Test
PST Genetic Test is a reliable way of assessing an individual's genetic risk for periodontal disease, the most common cause of tooth loss. PST Genetic Test is the first and only genetic test that analyzes interleukin 1 (IL1) genes for variations that identify an individual's predisposition for over-expression of inflammation and risk for more severe periodontal disease. The PST Genetic Test was developed following numerous clinical studies, and more than 40 peer-reviewed articles have been published on the test. PST is the only test shown in multiple long-term clinical studies to predict future tooth loss in dental patients.
About Interleukin Genetics
Interleukin Genetics, Inc. (NYSE Amex: ILI) develops and markets genetic tests that empower consumers to prevent certain chronic diseases and that assist pharmaceutical companies in the development and marketing of targeted therapeutics. The Company leverages its research, intellectual property and biomarker development experience to facilitate the emerging personalized health market. Interleukin Genetics is headquartered in Waltham, MA. For more information please visit www.ilgenetics.com.
Certain statements contained herein are "forward-looking" statements, including statements regarding the potential market for the PST Genetic Test. 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, 2008, quarterly reports on Form 10-Q and other filings with the Securities and Exchange Commission. The Company disclaims any obligation or intention to update these forward-looking statements.
SOURCE Interleukin Genetics, Inc.