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March 8, 2011 FDA Meeting Interleukin Genetics, Inc. Comments on DTC Genetic Testing Lewis H. Bender Chief Executive Officer Interleukin Genetics (OTC.

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Presentation on theme: "March 8, 2011 FDA Meeting Interleukin Genetics, Inc. Comments on DTC Genetic Testing Lewis H. Bender Chief Executive Officer Interleukin Genetics (OTC."— Presentation transcript:

1 March 8, 2011 FDA Meeting Interleukin Genetics, Inc. Comments on DTC Genetic Testing Lewis H. Bender Chief Executive Officer Interleukin Genetics (OTC QB : ILIU) Empowering Personalized Health

2 Interleukin Genetics, Inc. Molecular Diagnostic Sectors Consumers Lifestyle guidance (4 tests under Inherent Health brand) Medical conditions Risk assessment /Improve Care (PST® test sold only to dentists) Therapeutics Improving drug development 2 Started in 1987; Located in Waltham, MA; Small business ~20 employees Publicly traded US company on the OTC QB: ILIU CLIA certified laboratory; Products: Genetic laboratory developed tests. No other products sold.

3 ILIU Scientific Advisors & Selected Consultants and Partners Sir Gordon Duff, MD, BM BCh, FRCP, PhD, FMed Sci Florey Professor of Molecular Medicine; University of Sheffield, Sheffield, UK Chair, Commission on Human Medicines, UK Peter Libby, MD Mallinckrodt Professor of Medicine, Harvard Medical School; Chief, Cardiovascular Medicine, Brigham & Women's Hospital, Boston, MA Jose Ordovas, PhD Professor of Genetics, Tufts University; Director of the Nutrition & Genomics Lab, USDA Human Nutrition Research Center on Aging, Tufts University James Meigs, MD Associate Professor of Medicine, Harvard Medical School, Chair, Council on Epidemiology & Biostatistics, Am Diabetes Assoc.; Associate Editor, Diabetes Care John Foreyt, PhD Professor, Departments of Medicine and Psychiatry; Baylor College of Medicine, Houston Christopher Gardner PhD Director of Nutrition Studies at the Stanford Prevention Research Center and an Associate Professor of Medicine at Stanford University Steven B. Abramson, MD Director of the Division of Rheumatology at the Hospital for Joint Diseases at NYU Langone Medical Center Joanne Jordan, MD, MPH Herman & Louise Smith Distinguished Professor of Medicine; Director, Thurston Arthritis Research Center; Chief, Division of Rheumatology, Allergy, and Immunology at UNC Scientific AdvisorsSelected Recent Collaborators 3

4 Empowering individuals to maintain good health is in the public interest 4 Prevention is the key to improving health and lowering healthcare costs. Genetic test information has the potential to personalize medicine and personalize prevention. Genetic test information should be: Credible; Beneficial, Understandable, & Actionable Test* performance should be of good quality with analytical and clinical validity demonstrated -- regardless of the distribution Oversight of DTC test should be stratified based on risk *A “test” being defined as each single intended use (condition) reported to an individual in a report.

5 The Composition and Elements of Risk from Genetic Information A test’s risk stems from its intended use and the consequences or the actions resulting from the information Risk can be either mitigated or exacerbated by the quality of the information or the way it is communicated to the end user The risk of any test can be categorized as high, moderate or low 5

6 Defining High Risk Genetic Tests A test with high risk would be one in which validated genetic information provided to the user could potentially lead to immediate harm to that individual when communicated by a provider lacking important medical history necessary for the intended use. Such high risk tests (e.g. certain pharmacogenetic tests) should only be ordered and results reported by the individual’s physician. 6

7 Defining Moderate Risk Genetic Tests 7 A test with moderate risk would be one in which the intended use and resulting actions are such : that the user is unlikely to suffer immediate harm with effectively communicated information; and it is not necessary the medical history of the user be known to provide the genetic results Such tests (e.g. risk prognostic tests) should be permitted to be sold DTC However….. for conditions that are not currently treatable or preventable, the genetic information should be communicated by a trained provider for treatable and preventable conditions proper documentation provided to the individual would be sufficient communication

8 Defining Low Risk Genetic Tests 8 However, we believe that a regulatory strategy for all genetic tests, regardless of risk level, should include core elements to ensure test quality. A test with low risk would be one in which due to the nature of the intended use, the genetic information provided to the user is unlikely to lead to harm to that individual even with a result that is false (+ or -) or misinterpreted by the end user. Delivery of test results by trained professional is not required due to the nature of the information and low risk from such tests. Such tests (e.g. certain nutrigenetic tests) should be permitted to be sold DTC.

9 Core Elements of a Regulatory Framework for DTC genetic Testing For any level of risk test, certain elements are critical; Adequate Scientific Support for the Test. The amount of scientific evidence necessary to support the claims should be commensurate with the risk and degree of potential benefit of the test. Laboratory Certification and Analytic Validity. All clinical genetic tests should be conducted in a laboratory that is certified by an independent agency. CLIA certification is sufficient for DTC genetic testing and does not need to be replicated by another HHS agency. Proper Consent, Privacy and Disclosure. Persons undergoing genetic testing should be thoroughly informed about the test, provide proper consent and their results and privacy well guarded. We support the UK Commission’s guidelines as reported in

10 Proposed Registration and Listing for DTC Genetic Tests For moderate risk and low risk genetic tests that meet the definition of a medical device under 21 U.S.C. § 321(h) and that are sold DTC: Companies should register with FDA and list the tests they offer before they begin selling tests. Registration should include the name and intended use of each test, whether the test is low or moderate risk, and the CLIA identifier for the laboratory in which testing is performed. No premarket submission should be required. However, all test reports for moderate risk tests should include a disclaimer stating that the test has not been reviewed by FDA. 10

11 Genetic Information is a New Science and Becoming a Vital Healthcare Component Increasing access to quality information such as can be provided by genetics allows individuals to take greater control over their health issues and needs. DTC genetic testing offers great potential benefit as a new means to improve healthcare. Certain precautions and standards are needed to assure public safety and proper understanding of the new information provided by DTC genetic tests. Thoughtful consideration by regulators is needed to assure that private sector innovation continues to progress and translate genetic science to useful, available products and services. 11

12 Interleukin Genetics ILIU Empowering Personalized Health — Prevent— PersonalizePredict


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