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.

As Shannon reminds Jillian, our genetics help determine: “We are each born with a unique genetic code that tells our body how to grow and function throughout our life. This genetic code is made of DNA. DNA among individuals is 99% similar.”

Dr. Travis points out that though he and Jillian share 99% similar DNA, “it’s those subtle differences in your DNA can that can put you at risk for certain illnesses.”

Indeed it is that small percentage of genetic markers that differ from person to person can help illuminate our genetic predispositions for future health conditions.

For Jillian, her genetic markers showed that she had increased risks for breast cancer and deep vein thrombosis. Her lifetime genetic risk for breast cancer was about twice that of the average woman, and she was reminded that her healthy lifestyle and the mammogram she had (as part of another episode of The Doctors) are just a few of the positive action steps she can take to reduce her overall risk.

“This is just a piece of the puzzle,” said Dr. Travis, who got his own results from Navigenics two years ago. “It gives you an idea of some things you may be susceptible to. This is not one of those things that tells you your destiny. This is a reminder that if each and every day we try to optimize our health, we still do have control.”

“I’m glad to know it,” said Jillian.

Watch the full clip of Jillian getting her Navigenics results, click here.

You can see Travis and the other hosts get their own Navigenics results, or hear from audience members that went through the Navigenics experience, on past episodes of The Doctors such as Secrets to Living Longer (3/23/09) and Dynamic DNA (12/18/2008).

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.”

Since becoming the CEO of Navigenics, Dr. Vanier has guided the company based on a powerful idea—that the most effective and responsible way to empower individuals with genomics knowledge is with the support and partnership of corporate medical directors, health plans, and physicians. His work in building a series of clinical collaborations and distribution relationships have made Navigenics the #1 physician-endorsed company in the personal genomics space.  His leadership has driven positive change in the health care arena by effectively applying genomics to motivate behavior change and improved personal health.

The program itself is a unique mix of seminars designed to broaden the perspectives of the participants and hone their skills in values-centered leadership. In addition, each fellow undertakes an individual leadership project.

You can learn more about the fellowship here.

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

Moderator: “Welcome. In this podcast, we will discuss a recent study examining the clinical, psychological and behavioral impact of personal genetic testing.  The study appears in the upcoming issue of the New England Journal of Medicine.

Joining us today are Doctors Nicholas Shork, Eric Topol, and Vance Vanier. Doctors Shork and Topol are co-authors of the study and from the Scripps Translational Science Institute and the Scripps Research Institute. Doctor Vanier is the CEO of Navigenics, a personal genomics company that provided the tests for the study.

Welcome and thank you for joining us today.

Doctor Shork, could you tell us a bit more about the study?”

Dr. Shork: “Sure. We exploited a prospective study design in which we had an initial evaluation period. Then we provided the genetic risk assessment to the participants, and then had a follow-up approximately three to five months later to investigate how the genetic risk assessments may have impacted the health behaviors of the participants.”

Moderator: “And Doctor Topol, can you tell us the top-line findings of the study?”

Dr. Topol: “Sure. The findings were quite unexpected in some ways. That is, there was a lot of fear about genomic testing across 20 different diseases and there was a concern that the subjects who participated were going to be in a fretful, highly anxious state.  As it turned out, they were fine; there was no evidence whatsoever of psychological problems – anxiety production.  So that was a big part.

The second thing which was somewhat more sobering overall, is that we didn’t see lifestyle changes in the overall population as a function of their genetic, genomic results.

And then the other major finding that we had relates to the screening – medical screening – and there, what we saw were intent to screen as a reflection of what was the risk disease susceptibility.  So for example, colon cancer susceptibility led to colonoscopy.”

Dr. Shork: “We also learned that many people might be inspired to make changes in their health behaviors, and although we didn’t see significant changes after five months, we may see significant changes in their lives after a year or so.”

Moderator: “So, Doctor Topol, do you want to tell us a little bit more about how many people participated in the study and of those participants, how many worked with their physician?”

Dr. Topol: “Well, there were over 2,000 individuals who got their baseline genomic profile data, and then they also at about five months follow-up completed the surveys on the impact of having that data.  And of those, almost a fourth of them actually consulted with their physicians to go over their genomic information.  What was really interesting is those individuals did the best with respect to adopting healthier lifestyles.”

“So this is the first time that we were assessing the entire genomic profile on a large population for psychological effects and even more far reaching, looking at the impact of lifestyle as well as on changing medical screening behavior.  So, this was a very ambitious study, and of course we’re very grateful to have had the opportunity to collaborate with Navigenics to help us execute it.”

Moderator “Dr. Vanier, why did Navigenics participate in this study?”

Dr. Vanier: “All of us believe that the field of personalized genomics is going to be extremely important, but it’s clearly early years, and as such there are a lot of questions and sometimes misperceptions about the field. One of them, as Dr. Topol brought up, is whether consumers can really handle this information or if they’ll be fearful about it, and as such we think it’s enormously important to participate in studies like this to move the field forward. And the fact that Navigenics had the opportunity to partner with Scripps, which has a New England Journal publication over this [study], is an incredibly important ground-breaking step for the field.”

Moderator: “Dr. Topol, you spoke to this being the largest study of its kind. Dr. Shork, could you tell us a little bit more about some of the other features of the study?”

Dr. Shork: “Sure. Well, many of the instruments that were used in the study were actually designed by a licensed psychologist, Dr. Cinnamon Bloss, who is the lead author on the study.”

Moderator: “And what does that mean for the psychological implications of the findings?”

Dr. Shork: “Well it means that they’ve been vetted using validated instruments, lending some sophistication to the survey that maybe other studies don’t have.”

Moderator: “And Dr. Vanier, as a physician and CEO of Navigenics, what did you learn from the study?”

Dr. Vanier: “I think there are two major insights for me in the study - the first one revolving around the lack of consumer anxiety, and the second one revolving around the role that the physician could play in personal genomics.

So, the first insight around the lack of consumer anxiety revolves around the fact that any new technology, especially in the healthcare arena, has to overcome obstacles around potential consumer anxiety. Ninety percent of the thousands of people who were surveyed showed no widespread anxiety. Partially I think that’s because we have a philosophy to only test for clinically actionable conditions that you can do something about, but I think it also shows how far the field has moved in the last two years. For me the major insight is that this study really overcomes a lot of the mythology out there around potential consumer fear and anxiety.

The second insight for me revolved around the role of the physician. As Dr. Topol earlier pointed out, I, too was particularly interested in the 25 percent of respondents that took this information to their physician, because they were the ones much more likely to engage in lifestyle change in diet and behavior, which has been a holy grail for primary care physicians and for prevention in American society, and we’ve always felt that personal genomics is at its best when supported by some kind of healthcare professional or integrated with a wellness program, and I think this group of participants gave us an early glimpse into the potential of that.”

Moderator: “And Dr. Topol, would you like to expand on those findings?”

Dr. Topol: “Well, there’s several points, I think, that are worthwhile. Even though a fourth of the individuals consulted with their physicians to interpret and get some guidance, we now know that only ten percent of physicians feel comfortable in dealing with this genomic data – so we have a mismatch and this is something we have to deal with in the future.”

There’s also the point that,the negativism surrounding consumer genome-wide scans has been so profound, almost to the point of animus, against these tests – that it’s really nice to see that we have a large body of data to neutralize that negativism.”

Moderator: “And Dr. Shork, what did the study show about the role of genetic counseling, separate from the physician?”

Dr. Shork: “So approximately ten percent of the participants in this study took advantage of genetic counseling.”

Moderator: “And Dr. Vanier, how will this research inform Navigenics services and interactions with customers moving forward?”

Dr. Vanier: “So, for us, genetic counseling is a centerpiece to the service, and obviously as we watched the study progress we felt that a ten percent uptake was much too low.  And a lot of it had to do with the fact that we passively were waiting for people who underwent the testing to come to us to ask for genetic counseling, and we’ve learned from that because I think people don’t understand the value of genetic counseling currently in our society.

So as a function of this study, we’ve now engaged in much more active, proactive outreach, and now everybody who gets a test has a genetic counseling outreach call and as a result of that, the majority of people who take the Navigenics test now undergo a genetic counseling session.

I’d also add, to build on an earlier point that Dr. Topol made about the need for physician education – we’ve seen the genetic counselor as really playing an important role in two dimensions:  one is to help counsel people about the meaning of their results and how they can act on them, but two, also to educate the primary care physicians out there, the majority of which are still learning how to use and interpret this information.”

Dr. Topol: “Yeah, there’s a real paradox in that it, the surveys of consumers suggest that 90 percent feel that their doctor is the right one to go to with their genomic data, whereas 90 percent of physicians are uncomfortable, and it’s really a misplaced trust in the physicians because in that survey of consumers, of thousands of consumers, the genetic counselors didn’t get the respect that they deserve.  The other problem, this consumer genomics eventually does really grow, is that we only have what, 2,000 genetic counselors in the country for 300 million people – so we really have this mismatch, and that’s another reasons why eventually we’ve got to get the physician group up to speed, so that they can live up to the expectations of their patients.”

Dr. Vanier:  “This is an extremely important and groundbreaking step for the field of personal genomics.  This is an extremely important step in overturning a lot of the myths around consumer anxiety in regards to this information, and it gives us really important insights in terms of how we can help consumers take this personal genetic information and make it more actionable and actually affect lifestyle change, whether it’s through talking to their physician like 25 percent of the participants did, whether it’s getting genetic counseling or whether it’s integrating it with wellness programs.

And finally, I think it’s inspirational to all of us that as you look at the field of prevention as you look at the field of personal genomics, we have a lot of work ahead of us to make both of these fields even better.”

Moderator: “So Dr. Topol, what’s next for the field of personal genomics?”

Dr. Topol: “Well, the big movement now is in pharmacogenomics, and whereas people are not always enthusiastic about learning disease susceptibility and there are still some uncertainties and holes and all that story, the pharmacogenomics or the interrelationship between the drug impact of efficacy, side effects and one’s genome, is a really hot area.  We’ve learned about a lot of major interactions with commonly used drugs, whether it be to actually derive the benefit or serious side effects to avoid, and this is reshaping the field of therapeutics. So it’s very exciting and this is something that clearly is going to continue to explode in the times ahead.”

Moderator: “Well thank you, Dr. Shork, Dr. Topol and Dr. Vanier, for participating today, and thank you for joining our podcast.”

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.

The ultimate aim of the GAO report was to inform and protect consumers. At its best, the report sheds further light on an important and well known issue in the personal genomics field – how the current lack of regulatory standards can lead to very different approaches between personal genetics companies. But as the writers of the report acknowledged, they “did not conduct a rigorous scientific study.” As a result, many of the report’s findings are anecdotal, partially informed, or incomplete.

We would have been happy to work with the authors of the report to answer any questions or provide further information along the way. Our CEO testified at the hearing, and we filed thousands of pages of informational documents with the committee before the hearing. But Navigenics was not permitted to see the report before its release. Nor were our company’s representatives even allowed to see a copy at the hearing itself. As a result, we could not always fully address questions from Congressional representatives during the hearing, and regret not having been given the opportunity to prepare all the answers that were sought.

Furthermore, the report makes assertions that are backed up by incomplete information. We have made a formal request to the GAO for the detailed information behind these assertions. Should that detailed information be forthcoming, we are confident we can address any issue arising from the report. We are also appreciative of the fact that Congressional representatives, realizing the many questions left open by the report, extended the period of time to submit additional information for another 10 days. We look forward to submitting additional input to provide a more complete, more accurate picture of our company and our industry.

In the meantime, we will continue to pursue the path we started on more than two years ago. Our discussions with the FDA began even before our service first launched, and we most recently met with FDA officials in May of this year. We look forward to working further with the FDA to develop regulations for our industry at our next meeting with the agency next month. We also look forward to upcoming scientific studies of personal genomics services conducted by researchers at institutions such the Scripps Translational Science Institute, the Mayo Clinic, and Johns Hopkins. These studies, conducted with scientific rigor and involving participants whose only agenda was better understanding of themselves through their personal genetics, will provide useful, informative insights into how consumers interact with genetic information.

As plans for regulation unfold, we stand by our science, our service, and the standards we first proposed in 2008. A full demo version of the genetic results we provide, with no registration or signup required for viewing, is always available to anyone at www.navigenics.com/demo, and a full version of our Informed Consent has also aways been available for viewing without any required registration or signup. The FDA, along with other federal officials, is making productive steps towards a new framework for our industry. We look forward to continuing to be part of the discussion.

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. 

This update helps you and your doctor better understand what degree of customization your optimal warfarin dose may require, based on genetic factors. If you’re already a Navigenics member, you’ll find this update by logging into your personal genetic results for warfarin.

It’s also important to know that learning your genetic makeup related to warfarin isn’t enough. Only you and your doctor, working together, can combine your genetic results with other important personal factors, such as your age and weight, to calculate your dose. But as personal genetics become a more routine part of optimal dosing for this important, common drug, we’re looking forward to being part of the discussion. If you’ve got warfarin or other Medications results from Navigenics, how they’ve worked for you.

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.

To learn more about our work with regulators, see our press releases.

We appreciate and support the FDA’s mission and role in helping achieve the promise of personalized medicine. We believe our services comply with all existing federal and state regulations, and look forward to continuing our dialogue with the FDA to ensure transparency and the optimal use of genetic information as it applies to personalized medicine.

Our mission is to improve health outcomes across the population by providing clinically actionable genetic insights, and we believe that a healthcare professional should be an integral part of that process. We remain committed to providing support for individuals and their physicians at every step in the personal genetic analysis process – at no additional cost. We are the only company with a staff team of board-certified genetic counselors with years of experience specializing in personal genomics, and we have made physician education and clinical integration a fundamental focus of our service.
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