Biotechnology Healthcare - September/October 2008 - (Page 11)

PERSONALIZED MEDICINE Can Online Genetic Testing Predict the Future? Bob Carlson, MHA, Senior Contributing Editor W e bank, shop, and make friends online, so why not access our genetic profiles online? That’s the business model for Navigenics.com, deCODEme.com, and 23and Me.com — personalized medicine in the digital age. In fact, the principals behind these three start-ups see online direct-to-consumer genotyping and risk assessment as the driver for new models of consumer-physician interaction, medical research, and preventive healthcare. “I’m convinced that in the next 3 to 5 years, every college-educated person in the world will have a genetic profile,” declares Kari Stefansson, MD, DrMed, president, CEO, and cofounder of deCODE Genetics in Reykjavik, Iceland, the parent company of deCODEme. TRANSITION PERIOD The pitch is directed to consumers, but all three Web sites keep providers in the loop. Navigenics, in Redwood Shores, Calif., includes access to genetic counselors and engages the physician community on its website with pages entitled “Integrating our service into your practice” and “What we tell your patients.” Similarly, 23andMe THIS IS COMPLICATED features open letters to scientific and medical communiOne measure of these start-ups is the stature of the printies, and deCODEme cautions customers to “seek the adcipals behind them. 23andMe is the brainchild of biovice of your physician with any questions you may have pharmaceutical executive Linda Avey and healthcare inregarding the genetic aspects of a medical matter.” vestor Anne Wojcicki, wife of Google cofounder Sergey Disclaimers positioned discreetly at the bottom of their Web pages remind visitors that the service provided by 23andMe “is for research and educational use only”; “Navigenics does not provide medical advice, diagnosis or treatment”; and “The de CODEme.com website is for informational purposes only and should NOT be used for medical decision making.” Customers are asked to agree to a dense legal “service agreement and informed consent” document before parting with $985 for the services of deCODEme or $399 for 23andMe. Navigenics charges $2,500 for its Health Compass product, which includes such services as a whole-genome scan and roundthe-clock access to genetic counselors. If this comes off as a bit schizophrenic — deCODEme’s Web site touts the company as a pioneer in human disclaimers coupled with an invitation to genetics that has analyzed DNA from over 300,000 people worldwide. SEPTEMBER/OCTOBER 2008 · BIOTECHNOLOGY HEALTHCARE 11 take a bite out of the apple from the tree of genetic knowledge — it’s because this is all brand new, and caution is the watchword. Stefansson sees this as a “transition period” in which vendors are figuring out how to market their services while regulators are figuring out how to direct them. Some states have laws that don’t permit residents to obtain certain information about genetic risk provided by genotyping services; otherwise, few, if any, regulations apply — yet. “The regulations are unclear and evolving,” says Matt Crenson, content manager for 23andMe, headquartered in Mountain View, Calif. “They were designed for a different kind of genetic testing. I’m even hesitant to say that what we do is testing, because customers don’t go into this with any one question they expect to have answered.” Amy DuRoss, vice president for policy and business affairs at Navigenics, says her company discussed industry standards with, and solicited input from, key stakeholders —including its competitors, when entering the market. “We recognized a need for industry guidance to lay the foundation for standards and to protect consumer interests.” http://www.Navigenics.com http://www.Navigenics.com http://www.deCODEme.com http://www.23andMe.com http://www.23andMe.com http://www.deCODEme.com http://www.deCODEme.com

Table of Contents Feed for the Digital Edition of Biotechnology Healthcare - September/October 2008

Biotechnology Healthcare - September/October 2008 Openers Editorial/David B. Nash, MD, MBA Contents At a Glance: Multiple Sclerosis Drug Track Personalized Medicine Healthcare Reform’s Effects on Biologic Access Breast Cancer Status Testing: A Crapshoot With Deadly Odds Trends, Issues, and Perspectives In the Management of MS So High-Tech, Yet So Simple The Evolution of Ascertaining the Value Proposition Specialty Pharmacy Employer to Employer Health Plan Confidential Trends

Biotechnology Healthcare - September/October 2008

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