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.

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. 

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.

But your genetic makeup has a lot to say about how you respond to certain medications.

Now, a new type of genetic result from Navigenics can help you take even stronger strides towards a healthier future, by helping you understand which medications work best for you.

Your genetic code holds important information on how you respond to particular medications, and our new results help reveal it. The new Medications feature of the Navigenics service analyzes your genetic responses to 12 prescription drugs. These include everything from common medications, such as drugs designed to lower cholesterol or prevent blood clots, to more specialized drugs used to treat cancer or epilepsy. (See our complete list of medications.)

And when it comes to Plavix®, that fact has some scientists working to see how genetic testing can provide better answers for people who take this medication.

Some people, because of their genetic makeup, don’t process Plavix® as effectively as others, leaving them vulnerable to dangerous blood clotting problems. In March, the U.S. Food and Drug Administration revised the drug label on Plavix® (also known by its generic name clopidogrel), emphasizing that people who carry certain genetic variants may not benefit fully from the drug. The FDA announcement also stressed that testing is available for a gene linked to a reduced response to Plavix®.

Since the vast majority of people who’ve taken Plavix® have never undergone genetic testing, researchers are now analyzing the ways that genetic insights can help.

And to help our members turn their personal genetic information into better health, we work closely with a wide range of healthcare organizations and professionals. Our team of board-certified genetic counselors is available to help our members make the most of their genetic results. And we partner with many other healthcare researchers and providers.

One of our collaborators includes the Toronto-based Medcan Clinic. Medcan offers the Navigenics Health Compass to its members, and pairs the results with support and expertise from a Medcan genetic counselor, who helps further personalize and interpret each patient’s genetic information. This week, Medcan’s Director of Genetics, Jill Davies, blogged about her experience with incorporating personal genomic results into patient care.

Here’s a highlight from her very interesting post, written for The DNA Exchange, a blog authored by genetic counselors:

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Navigenics, a leading personal genomics company, announced today that the company has raised approximately $18 million of funding. The Procter and Gamble Company, with a worldwide portfolio of leading consumer brands, has joined existing Navigenics investors Kleiner Perkins Caufield and Byers and Mohr Davidow Ventures who also participated in this financing round.

“I welcome the partnership of Procter and Gamble. Their extraordinary track record of consumer understanding provides Navigenics with an unparalleled opportunity to understand and serve the needs of our customers,” said Vance Vanier, MD, Navigenics President and CEO. “When combined with their commitment to developing innovative consumer health and wellness products and an expanding focus on health services, P&G’s insight and brand will strengthen Navigenics’ position to embed personal genomics into the prevention dialogue of everyday health care.”

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Navigenics, a leading personal genomics company, announced today that Vance Vanier, MD, has been appointed by the Board of Directors to serve as President and Chief Executive Officer of the firm.

Dr. Vanier joined Navigenics as Chief Medical Officer in April of 2008 and has been instrumental in growing the company’s clinical offerings as well as institutional research and corporate partnerships. Prior to joining Navigenics, he was a partner at venture capital firm Mohr Davidow Ventures where he spent years in the molecular diagnostics industry bringing new genomic technologies into clinical practice. Vanier also serves as a clinical faculty member of Stanford University Medical Center.

The permit makes Navigenics the first personalized genomics service to be licensed as a clinical laboratory by the State of New York.

The permit, issued on December 7, gives Navigenics approval for its CLIA-certified clinical laboratory to process saliva samples originating in the State of New York for the purposes of genetic testing. The permit acknowledges that the State’s Clinical Laboratory Evaluation Program found the validation data for Navigenics’ test acceptable and clarifies the regulatory framework that Navigenics will operate under in New York moving forward. 

A large new scientific analysis of coffee and tea drinkers has found that these favorites—even the decaf versions – can help reduce your risk of type 2 diabetes.

The recent research, published in the Archives of Internal Medicine, found that every additional cup of coffee each day was associated with a seven percent reduction in the excess risk of diabetes.

The more tea or coffee a person consumed, the more diabetes risk declined. Drinking three to four cups a day meant about a 25 percent reduced diabetes risk when compared with those who drank between none and two cups day.

Even decaf made a difference.