Agenda. The Trends The Consumers The Companies Regulatory Environment Opportunities for Labs

Transcription

1 Agenda Why Sophisticated Genetic Testing via Internet Sources is a Direct-to-Consumer Trend Trisha Brown, M.S., C.G.C. Vice President, Clinical Affairs DNA Direct May 14, 2008 The Trends The Consumers The Companies Regulatory Environment Opportunities for Labs 2 1

2 Genetics is receiving increased media attention DNA has become part of the common lexicon 3 4 2

3 Technology costs are rapidly dropping Genetics is redefining common disease

4 Genetic services companies are attracting investors Social networking for the MySpace generation 7 8 4

5 Growing consumer interest in genetics 2007 survey of 1,199 Americans over age 18 support genetic testing 93% for research 93% for reactions to medicine 91% for diagnosis when treatment available 86% to find out risk of serious disease in offspring 79% to determine disease risk when no treatment exists Consumers have privacy concerns 92% of Americans surveyed are concerned that genetic test results could be used in a harmful way

6 There are barriers to accessing genetic testing Agenda Physicians Lack Genetic Expertise NEJM study revealed that physicians struggle with management of genetic tests Shortage of Genetic Experts 100K patients 175 drs. 1 Geneticist For every 100K patients, there is only 1 genetic expert The Trends The Consumers The Companies Regulatory Environment Opportunities for Labs The Impact On Patients: Limited access and awareness of appropriate genetic tests Receive data rather than information from genetic tests

7 What is Direct to Consumer? The typical consumer seeks DNA Direct s services because of a medical concern Direct Access Testing (DAT): patient orders a lab test directly from a lab without a physician involved Direct to consumer marketing: Marketing messages to consumers, but physician order still required Patients are consumers More than 10% have a known family mutation More than 50% have a personal or family history About 40% test positive Some lack access - either no genetic services in their region or their doctor didn t see value in testing Some seek convenience and anonymity- prefer testing at home and counseling by phone v.s. in-office visits

8 Customer inquiries: The Worried Well Customer inquiries: The Well-Bodied dear mr.or miss we would like to know every thing about our dna.what kind of disease we are liable to. So please send us a procedure how can we contact to you or what we have to do. Many regards K.M. I am interested in getting my DNA tested for the reason of finding out if I come from Jewish Decent. My grandmother was Italy so I know very little of her family lineage, and because Jewish lineage goes through the mother I really would like to know if I am jewish. What testing should and can be done to accurately find this out for me?

9 Customer inquiries: The Rightly Worried Our view of the market for genetic testing I am trying to find out a couple of answers to some questions regarding inheritance of the gene for CF.I have a grandson who may or may not have it. My son was tested twice, the first test came back negative for 93%, the second came back as negative as well for the rest. My daughter-in-law is a carrier. The Doctors are saying there is a chance that my grandson is inflicted with the disease. They say Mom's gene could have multiplied so that there are two genes. Is this possible? We are looking for any help you may give us. Worried about their health and willing to spend $$ for prevention Curious about technology but not worried about their health The Worried Well The Well- Bodied The Rightly Worried Medical or family event that indicates increased risk

10 Agenda Business Models The Trends The Consumers The Companies Regulatory Environment Opportunities for Labs Fee-For-Service Pay per test (lab and access fees) Pay per service (phone consultation, web reports) Subscription service (come back for updates) Monetize Traffic Build a social network Advertising Data repositories Products (diets, vitamins, cosmetics)

11 Not all DTC genetic tests are the same Not all DTC services are the same Clinically Valid Covered benefit Chromosome test In medical guidelines sdna for co.cancer screen Thought leader recommends PGx for warfarin Strong science APOE for Alzheimer s Quality Professional/clinical Physician oversight and authorization, genetic counseling, informed consent, family and medical history review, transparency of clinical validity Late research Prostate cancer Genome Scans Whole Genome Sequencing Genome scans Genetic counseling, risks in context with family history, transparency of science Information only Early research Baldness Nutrigenomics Dermatogenetics Lack of clinical validity 21 Diet advice Wrinkle cream Controversial Quality Tailored products 22 Focus on selling products (nutrients or cosmetics) 11

12 DNA Direct sample report Customized to family & medical history pages depending on test & result Based on Genetic Test Results Embeds lab report, physician letter & family letter Provides access to additional resources Helps user build an action plan for next steps genetic counseling phone support

13 DNA Direct sample report DNA Direct sample report Customized to family and medical history Explanation of risk at patient s education level Embeds lab report, physician letter, family letter Checklist of detailed nextsteps Access to supporting tools and resources Tools for continued decision support

14

15 as accessed on 5/8/

16

17

18

19

20

21

22

23 as accessed on 5/6/

24 as accessed on 5/8/

25 Agenda Growth of tests raises alarms The Trends The Consumers The Companies Regulatory Environment Opportunities for Labs

26 Increasing clamor for greater regulation CLIA Secretary s Advisory Committee on Genetics, Health and Society Marketing of unproven genetic tests a threat to public health April 2008 The FDA should address all laboratory tests, regardless of how they are produced (ie, commercial kit or laboratory developed test) because it will be increasingly difficult to distinguish genetic testing from other complex laboratory testing, we chose to apply a number of our recommendations to laboratory tests generally. April A laboratory is defined to be a facility that performs certain testing on human specimens in order to obtain information that can be used for the diagnosis, prevention, or treatment of any disease or impairment of a human being; or the assessment of the health of a human being; or procedures to determine, measure or otherwise describe the presence or absence of various substances or organisms in a human body (42 C.F.R. sec )

27 What some companies say DeCode CEO Kari Stefansson emphasized at the time of the firm s launch of the DeCodeMe service that it is not offering a genetic test. We strongly encourage you not use this to make medical decisions, he said during a webcast. GenomeWeb News April Anna Vitebsky, Consumer Genetics' product manager, said she did not believe the company had to comply with the state law that requires a physician to order the tests because the company doesn't offer diagnostic tools. She described the services as "fun well-being tests" that do not involve disease testing or a medical diagnosis. SF Chronicle April 24, as accessed 5/6/

28 Ordering tests States regulate who can order a lab test Varies by state. 25 states permit DTC without restriction, 12 permit for certain categories, and 13 prohibit entirely FDA Oversight of medical devices and kits Plan oversight of high risk tests IVD-MIAs Through the FD&C act has authority to regulate cosmetics FDA can regulate vitamins and supplements considered to be treatment for disease

29 Agenda Opportunities for Labs The Trends The Consumers The Companies Regulatory Environment Opportunities for Labs Consumer driven access is here to stay ASCLS supports the consumer's right to have unfettered access to their own medical information and to clinical knowledge in a manner which he/she can understand. ASCLS supports the role of certified clinical laboratory scientists in the development of a DAT program. as accessed on 5/6/

30 Opportunities for Labs Capitalize on consumer interest in genetic tests Ensure providers and their patients have resources to help them understand the utility of your test and how to obtain it Evaluate partnership opportunities with genetic services companies Facilitate the ordering of genetic testing Provide educational material for physicians and patients that is easy to access Clinical utility and scientific validity of test should be transparent and help providers order the right test Experts should be available for pre-test consultation 59 Opportunities for Labs Make lab reports understandable for physicians and patients Provide a comprehensive, easy to understand result interpretation Provide decision support tools to aid in pretest and post-test education Provide experts for consultation 60 30

31 What To Avoid In Summary Media attention and consumer interest will continue to fuel direct-access genetic services As the market matures and the regulatory framework evolves, winners will emerge in the genetic services market Labs are in a unique position to provide solutions and bridge gaps Labs can capitalize on consumer interest in genetic testing by working with providers to provide consumer-friendly resources