Today, Navigenics makes its fourth appearance on The Doctors TV show.

On today’s episode, Jillian Michaels receives her genetic results from Navigenics genetic counselor Shannon Kieran, M.S., CGC. Jillian, a celebrity personal trainer best known for her appearances on The Biggest Loser and Losing It With Jillian, was eager to find out her own genetic predispositions.

“I am a firm believer that knowledge is power and in preventative medicine, so I’m ready,” said Jillian.

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Navigenics CEO Vance Vanier, M.D., has been named to a 2011 Henry Crown Fellowship.

He joins a group of 20 other entrepreneurs and executives, all under age 45, chosen by the Aspen Institute’s Global Leadership Network for their potential to make significant contributions to some of today’s biggest challenges. 

Individuals cannot apply for a Henry Crown Fellowship. Instead, they must be nominated by recognized leaders in the business and professional communities, by fellows, or by Aspen Institute leaders.

Those selected for the two-year program have already achieved considerable success in the private or public sector and are poised to take on a broader role, either in their communities or globally.

“I’m thrilled at the opportunity to be part of this visionary group of leaders,” Dr. Vanier said. “And I’m looking forward to the insights that will emerge as we exchange ideas on genomics, technology, health care, and much more.”

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Today, the New England Journal of Medicine (NEJM) published findings from the Scripps Genomic Health Initiative, a research study sponsored by Scripps Translational Science Institute (STSI) to assess the behavioral impact of personal genetic testing.

The Scripps Genomic Health Initiative provided study participants who were age 18 and older with personalized genetic risk assessments for more than 20 health conditions that may be changed by health screening and lifestyle, including diabetes, heart attack and some forms of cancer. The study was launched in 2008 and will assess changes in participants’ behaviors over a 20-year period. As a co-sponsor of the study, Navigenics provided the genetic testing used in the research.

Initial results from the Scripps Genomic Health Initiative (SGHI) are published in an article on the New England Journal of Medicine’s website, www.nejm.org. You’ll find Navigenics’ full press release on the initial findings here.

As the first major study of its kind, this research will undoubtedly influence the ongoing evolution of the personal genetic industry. Dr. Vance Vanier, CEO of Navigenics, joined SGHI researchers Drs. Eric Topol and Nicholas Schork in a webcast to discuss the research findings and implications on the industry.

You can view the webcast in the video above, and a full transcript of the webcast also follows below. Participants include:

Eric Topol, MD, PhD
Scripps Translational Science Institute, Scripps Health & The Scripps Research Institute
Author of the Scripps Genomic Health Initiative study

Nicholas Schork, PhD
Scripps Translational Science Institute & The Scripps Research Institute
Author of the Scripps Genomic Health Initiative study

Vance Vanier, MD
CEO of Navigenics

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Validity. Accuracy and quality. Clinical relevance. Security and privacy. These were among the top themes highlighted over and over when federal officials convened a series of meetings and hearings last week in the Washington D.C. area to discuss the prospects for personal genomics services and other innovative types of health-related tests.

For long-time readers of this blog, these ideas are nothing new. When Navigenics launched its personal genome service more than two years ago, we issued a 10-point proposal for a set of industry standards to ensure the integrity of this new field of science and health and safeguard consumers. We reiterated the need for these principles again early last year, when we helped the Personalized Medicine Coalition convene a meeting on standards for personal genomics services.

So when last week’s events kicked off with a two-day meeting called by the U.S. Food and Drug Administration, we were pleased that the need for industry standards has been acknowledged at a high level. At the gathering of experts in health, genetics, science, and the law, many good points were raised and excellent ideas exchanged. Navigenics was among a group of leading personal genetics companies that presented a company overview to the gathering, and our CEO, Vance Vanier, M.D., was the only executive from a personal genomics service given the opportunity to speak on a panel. In its inclusiveness, broad discussion, and scientific rigor, the FDA meeting reflected the type of approach and expertise that will be required to develop effective standards for personal genomics.

The next day, however, saw a very different – and less productive – atmosphere come to light. On Capitol Hill, a subcommittee of the House of Representatives’ Committee on Energy and Commerce held a hearing on “Direct-To-Consumer Genetic Testing and the Consequences to the Public Health.” A key part of this hearing was a report by the Government Accountability Office, or GAO, on 15 personal genetic testing companies.

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It’s one of the more common prescription drugs, but until you need warfarin, you may have never heard of it. Sold under brand names including Coumadin® and Waran®, this blood thinner is prescribed millions of times a year in the United States to help treat or prevent blood clots. If you are undergoing major surgery, or experiencing conditions such as an irregular heartbeat or DVT (deep vein thrombosis), your doctor is likely to prescribe warfarin or another blood thinner.

But even though warfarin is common, it isn’t always easy to use. Finding the right dose for any one person is tricky, and the process often begins with trial and error. Too little of the drug, and a person can still experience a dangerous blood clot. Too much warfarin, and a person can suffer hazardous bouts of uncontrolled bleeding. Some of this individual response depends on personal genetics. Safe, effective warfarin use requires carefully calculated personalized dosing, and personal genetic information can be a helpful part of that equation.

At Navigenics, we recently launched a new Medications service, which provides personalized genetic information to help you understand which prescription drugs may work best for you. Warfarin is one of 12 medications analyzed in this feature of our service. The warfarin-related genetic results we provide can be used by your doctor to help calculate an individualized warfarin dose, using tools such as the calculator provided by www.WarfarinDosing.org.

This week, we enhanced our warfarin results further by providing an even more specific explanation of what they mean for personal warfarin dosing. 

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Recent news in the personal genomics industry has prompted interest in how we work with state and federal regulators. At Navigenics, this interest is always appreciated. Since starting our company, we’ve sought to work closely with regulators, and consider this approach as one of our founding principles.

Navigenics has an established history of working closely with state and federal regulators:

• Navigenics has helped lead the effort to set industry standards for personal genomic testing services in cooperation with the Personalized Medicine Coalition and other industry organizations.
• Navigenics has consistently been a leader in encouraging collaboration and dialogue with regulatory authorities – at both the state and federal levels – to ensure compliance and develop standards for the industry’s innovative technologies and services.
• The New York State Department of Health issued Navigenics a clinical laboratory permit in January 2010, making Navigenics the first personalized genomics service ever to be licensed as a clinical laboratory by the State of New York. To date, we are the only personal genomics company permitted to offer its services in New York.
• Navigenics was granted a license by the State of California’s Department of Public Health in 2008 to provide genetic laboratory testing services to customers within the state.
• When Navigenics launched its personal genome service more two years ago, we issued a 10-point proposal for a set of industry standards to ensure the integrity of this new field of science and health and safeguard consumers.
• We highlighted the need for these principles again last year when we helped the Personalized Medicine Coalition convene a meeting on standards for personal genomics services.
• Navigenics has met with the FDA half a dozen times to discuss its services and the potential standards that could apply to the industry, with its first meetings dating back to 2007.
• We operate consistent with HIPAA practices and build them into our infrastructure.

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