Pathway Genomics Corporation

1. Pathway Genomics Corporation Ed MacBean Vice President, Product Development Presentation to: Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee March 9, 2011

2. Personal property rights to DNA in 37 states • Called in front of Congress, discredited in the media, and business stalled for at least 6 months but still no clarity on what we did that was illegal • Decision by the United Kingdom not to regulate DTC testing • Another report, from Scripps, demonstrating that patients can handle genetic information • Inconsistent enforcement of ‘illegal’ DTC testing • Hindering innovation, investment & jobs, advancement of this field while other countries are making rapid progress • Low-cost sequencing is coming fast, introducing significant complexity to regulatory framework What to discuss?

3. All genetic information is not the same • Different risks and different intended use for different audiences • Informational ‘devices’ such as genetic data are new type of product • Deserve an innovative approach to regulation • National registry of medical devices • Scalability and flexibility SUMMARY

4. Pathway Genomics believes: • People have a right to their own health information, including genetic data • Genetic information can be provided directly to consumers to help them improve their health and wellness • Improve outcomes through education and motivating positive health and lifestyle choices • Lower costs of care through easier access and prevention • Pathway Genomics acknowledges • FDA’s responsibility to protect the public • Need to ensure that information is accurate and delivered responsibly

5. Different Genetic info. PREsents Different RISKs Information used by Individual in education, wellness and prevention Information used by Physician to inform treatment and intervention Possible Consumer Risk Mitigated by education and professional expert involvement Traits (Baldness, Sprinter) Recessive Carrier Status Wellness/Motivational Risk Factors (Non-diagnostic risk information) Dominant Monogenic Drug Response Ancestry Types of Genetic Testing/Reporting

6. Evaluate Information products as analytical tools • Review of algorithms and analysis models, not individual tests • Methods of selecting and calculating odds ratios, presenting information (adjusted lifetime risk, binning systems, etc) for risk factors • Criteria for selection of markers from published research for analysis of recessive markers, drug response • Methods of qualifying research, such as our Scientific Strength Research Rating System • New data that is consistent with the approved models does not require additional submissions • Flexible enough to keep pace with the rapid rate of discovery • Allow competitors to compete and innovate to make best product and service available to providers • Ensure that information is reported accurately and responsibly

7. ESTABLISH DATABASE for all medical devicEs Every company that wants to market a medical device must register their company, each product and every marketing channel with FDA. 1. Company Info and Certifications CAP # ____________ CLIA # ____________ 2. Is the medical device intended for: ☐ Diagnosis ☐ Cure ☐ Mitigation ☐ Treatment  Prevention of disease 3. The type of information in the report can best be described as  Diagnostic  Risk factors  Drug Response  Diet/Nutrition 4. Is device being marketed to:  Individuals  Physician (MD, DO)  Other licensed clinical specialists 5. Expert clinical oversight is Provided by patient’s physician  Provided by company N/A 6. Product is to be distributed to end consumers via  Physicians  Hospitals/Clinics  Retail Stores  Internet

8. Binning for approved access • Color-coded and graphical icons to clearly indicate the recommended level of oversight • Direct supervision of an MD • Physician or genetic counselor oversight recommended, but not required • DTC approved

9. Guidance based on devicE registration • Automated guidance base on registration information • What is the appropriate regulatory path (None, 510(k), PMA) • Provide specific directions around rules and disclaimers that must be used within that regulatory path

10. Clearly link database to products • Require vendors to display unique company and product identifiers on all products and communications • Identifiers searchable on FDA site, exposing select data to inform public of current FDA status • Establish clear binning system to communicate guidance to consumers • Engage consumers in identifying the ‘bad apples’ Retail Website / Marketing Materials

11. Additional value from device registry • Reference database for FDA • Insight into the activity in the marketplace • Proactively identify emerging issues and contact vendors with concerns • Responsive to emerging technologies, business models and concerns by adding new questions and guidance into the system • Process for appealing guidance • Equal treatment across marketplace

12. CONCLUSION • Genetic information not all equal • Varying types of information deserve different levels of oversight • Medical information already delivered to and processed independently by individuals • Information products deserve different evaluations • Review methods of handling information • Medical Device Registry • Every product registered in a standard database • Standardize guidance, offer clarity into uncertain processes for novel technologies • Collect and share data to make vendors, consumers, and the FDA more informed