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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At Navigenics, our personal genetic results focus on health. Our genetic testing services only cover common, important health concerns that you can do something about.

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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Today, Navigenics announced information about new financing and a new investor. You’ll find the official Navigenics press release below:

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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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Today, Navigenics made an important leadership announcement. Here is the text of the official press release:

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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.

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Navigenics., a leading personal genomics company, announced today that the New York State Department of Health has issued Navigenics a clinical laboratory permit and approved the offering of the company’s Navigenics® Health Compass service to New York State residents.

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. 

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At Navigenics, our team is used to being recognized in the fields of genetics and medicine. But being described as “hot”? That turf is, well, a little less familiar to most of us in the genetics world. So imagine our attentiveness when San Francisco-based magazine “7x7” revealed one of its most anticipated features of the year today – the “2009 Hot 20 under 40.” Among the publication’s list of the “most impressive San Franciscans:” Navigenics Chief Operating Officer Sean George, who was photographed with his 2-year-old daughter, Claire.

George, who has a Ph.D. in molecular genetics, was profiled alongside the likes of San Francisco Giants pitcher Tim Lincecum and Ning co-founder Gina Bianchini, to name a few.

“What’s ‘hot’?” the 7x7 editors mused in describing their selections. “A pitcher with a killer arm, tech wizards bringing Wi-Fi to the world or a gender-bending performance artist? One thing’s for sure: Everyone below is under 40 and has a sense of self that belies their years. We’re just lucky enough to benefit from it.”

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Celiac disease, a serious digestive condition, is common in more ways than one – in how often it occurs, and how often it goes undiagnosed. The prevalence of the disease has increased significantly in the United States during the last 50 years, researchers at the Mayo Clinic recently determined.

“Some studies have suggested that for every person who has been diagnosed with celiac disease, there are likely 30 more who have it but are not diagnosed,” said Mayo gastroenterologist Dr. Joseph Murray in a written release. “And given the nearly quadrupled mortality risk for silent celiac disease we have shown in our study, getting more patients and health professionals to consider the possibility of celiac disease is important.”

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Navigenics has a strong showing on Health Spottr’s Future Health 100 list. Health Spottr is a new media publishing company devoted to covering the latest in health care innovation and the top players in health care.  Among its new list of 100 influential health care providers, investors, innovators and executives are Navigenics leaders Dr. Jonathan “Jack” Lord and Dr. David Agus.

Dr. Jack Lord, CEO of Navigenics, is featured at number 19 for his commitment to quality improvement in health care. Dr. Lord discusses the importance of Navigenics’ genetic testing services in the future of health care. “These are all progressions on the same basic track of getting people to a place of sovereignty over their healthcare—putting them on the same level as their doctors in the decision-making. Navigenics represents the next step. We provide people with a science-based view of their future risks, then give them resources to understand how they might impact those risks.”

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Many physicians recommend the Navigenics genetic testing services to their patients as a way to help build a more personalized plan for disease prevention and better health. But doctors themselves also tell us how genetic insights improve their own lives. William, director of oncology at a leading diagnostic center, recently wrote to us about his own genetic discovery.

“My analysis was mostly reassuring, but showed two areas of increased risk,” he said. “One was for prostate cancer, which was not a surprise since my father died of prostate cancer. The second was celiac disease, which was a surprise. Although in retrospect, I had some subtle signs and symptoms which could be attributed to celiac disease: Poor digestion of fatty foods, low serum cholesterol, a mysterious skin rash, and recurrent aphthous ulcers,” or canker sores.

He followed up on his Navigenics results by getting two diagnostic tests for celiac disease—a blood test that looks for celiac-related factors and an upper endoscopy, which allowed his doctor to see inside his digestive tract and look for the tissue damage caused by celiac disease.

Both tests were positive, and showed that he already had a moderate to severe form of the disease.
From there, William knew that he could use his genetic test results to take action.

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There has never been a better time to take control of your health.

Navigenics has reduced the cost of our comprehensive genetic testing services to $999.

Our Health Compass test identifies your genetic predisposition for a wide variety of common conditions such as colon cancer, breast cancer, Alzheimer’s disease and type 2 diabetes, among others.

Not only do you get results, you get a plan of action and guidance to take the next steps.  Our board-certified Genetic Counselors are available to help you understand your results and how you can work with your doctor to minimize your individual risks.

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It was late Friday night – the email arrived to let me know that my Navigenics genetic test results were ready. 

I thought for a second – am I ready?  But without another thought I logged in and there they were.

As I scanned the private report, I realized that there was a lot of information. I went from top to bottom, focusing on the conditions that were important to me – heart attack, Alzheimer’s, diabetes.

My quick read was “relief” – no surprises – the conditions that I was at higher than normal risk for were ones that occurred in my family.  My dad lived to age 87 and my mom to age 84; the conditions that I think I need to pay attention to were the same ones that they were afflicted with.

But I have the chance to do something about it.

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Of course we know that all human beings are related, but sometimes genetic analysis drives this point home even more strongly.  If you carry a rare variant in the Factor V Leiden gene – which has just been added to the Navigenics genetic testing service – you share a common ancestor with every single person who carries that variant.

Factor V (pronounced “factor five”) is a “founder mutation,” a genetic change that originated in one individual long ago and can now be found in that person’s descendants around the world.  This mutation is present in two to 15 percent of Caucasians, but is rare in genetically distinct non-Caucasian populations. 

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Navigenics has joined healthcare leaders across the country to support a new Declaration of Health Data Rights.

The statement aims to ensure patients’ ability to access and share their own personal health information.

The declaration, which appears on the website HealthDataRights.org, was drafted in response to the difficulties many patients have reported experiencing while attempting to obtain their personal medical records from hospitals, health plans and doctors.

It stipulates that we should have the right to access our own health information so that we can make the best medical decisions for ourselves.

The tenets are simple. The document declares that we the people:

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Navigenics has made some significant additions to our genetic testing services.

Five new health conditions have been included in our test panel, and we have added 53 SNPs for a dozen existing conditions, which enhances the predictive ability of our genetic tests. We have also made improvements to our Alzheimer’s disease test. 

With these changes, our Health Compass customers will receive the most up-to-date results.

Read on to learn more about the new conditions.

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The first consumer genetics conference gets underway in Boston today, bringing together leaders in the fields of genetic testing, health, genetics and law.

The Consumer Genetics Show was born out of the growing interest in personal genetic testing, and will address key issues in the field, including scientific advances, best practices, and how to navigate the healthcare system. Doctors will learn more about the genetic testing field and how they can help their patients decide which genetic test is best for them.

The Consumer Genetics Show has attracted a veritable who’s who of the personal genomics industry.

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To a lot of people, genetic testing still sounds like futuristic fiction. And that means people come to us with different misconceptions of what genetic testing is all about.

To help address some of those perceptions, we’ll start blogging from time to time about common myths that surround genetic testing and try to set the record straight.

Here’s one misconception our genetic counselors often hear:

Myth:  My DNA is my destiny, and I don’t want to know.

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At a time when most personal genetic testing companies do not even offer genetic counseling to their clients, Navigenics, I’m thrilled to report, is expanding our counseling program.

Genetic counseling from a qualified professional is a critical part of the genetic testing experience. Genetic counselors are healthcare professionals who are trained to help you understand what genetic information means for you and your family – and whether testing is appropriate for you. We work with you to put your results into context and discuss ways to integrate the information into your life. 

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Heather Bonaguidi is making an effort to include more anti-oxidants and whole grains in her diet.

Rashaad Forehand is drinking less alcohol and cutting down on his ice cream intake.

These are the sorts of healthier choices we’re all told to make, and that many of us ignore. But Heather and Rashaad have extra motivation – they’ve learned about some of the personal health risks carried in their DNA.

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After little more than a week at Navigenics, I have had the chance to touch the power of genomic science.

For thousands of years, people have searched for ways to see their future, turning to shamans, palm readers, tarot cards and horoscopes. And the answers that they got were useful if they believed in how they got them, but to a “scientific” observer they were answers without proof.

In the past 20 years, genomic science has unlocked many of the “secrets” about us, and in the past few years, that science has allowed us to translate discoveries into practical guidance.

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Alzheimer’s disease, long a condition deeply feared because it seems so hopeless, is getting a new look from a brighter angle.

This week, HBO is airing a new documentary series, “The Alzheimer’s Project,” that includes two segments on promising new research. As the online introduction to the series says, “There is no cure – but there is hope.”

The Alzheimer’s Association, a partner in the HBO project, is leading a new push for advocacy, awareness, and a search for treatments.

And at Navigenics, we are helping our members learn about their genetic Alzheimer’s risks, so that they can be aware, informed, and involved on a personal level earlier.

Recently, ABC’s “Nightline” co-anchor Terry Moran became his own news story as he turned the cameras onto himself and got a Navigenics genetic test to learn whether he had a genetic predisposition for Alzheimer’s disease. He shared his concerns, his family history, his results, and his reactions with the millions of Americans who tuned in.

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Some people prefer shopping online, whether it’s a book, movie ticket or a genetic test that they’re seeking. Others would rather have more personal interaction and feel the most comfortable talking to a physician about anything even remotely related to their health.

With that in mind, Navigenics has made it much easier for consumers to find physicians who have been trained in integrating our genetic testing into their practice. We’ve just introduced a new “Find a physician” feature that enables customers to select from a growing list of physicians offering the Navigenics genetic testing services to patients.

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Genetic testing is a relatively new field, and not surprisingly, many consumers have questions about it. What are the benefits? What are the risks? And perhaps most importantly, is it right for me right now?

Dr. Eric J.Topol, director of the Scripps Translational Science Institute in San Diego, discusses these issues in a thoughtful new video blog called “Are Genome-Wide Scans Ready for Prime Time?”

Should people get a genetic test now to learn their genetic risk for many common health conditions? Should they wait until scientific research has yielded even more information about the genetic underpinnings of health before they proceed?

While naysayers have suggested that consumers should put off testing until all the pieces of our genetic puzzles are in place, “There’s no real answer to this debate,” Topol says in his video, which was posted on Medscape, a website for physicians.

Certainly, sound science will bring new advances to the field in the future. But that is no reason not to get a genetic test today.

“There is another view here, and that is by having this information that may be empowering to individuals – and that may be a good thing,” Topol says in the video.

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Here at Navigenics, some of the questions people ask us frequently relate to genetic testing and family health history. Doesn’t family history provide enough health information all on its own? How do genetic test results work with family history?

The short answer is that family history is important, but it can’t provide the whole story.

Many women who develop breast cancer, for example, have no family history of the disease. And someone who lost a grandfather and a father to heart attacks is not necessarily destined to have the same fate. Your genetic makeup is very individual in some important ways, making personal genetic information a valuable addition to family history.

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Genetic testing is a tool that can help you, and your family, take control of your health by making personalized, informed healthcare decisions. There are lots of different kinds of genetic tests: for rare conditions that only affect a small number of people, for ancestry and paternity, and now tests are available for common diseases like cancer and diabetes.

But as the number of companies offering genetic testing continues to grow, it can be confusing for many consumers to determine which service is the best, the most reliable, and the most appropriate for their needs. Not all genetic tests are created equal, and some genetic testing companies do not offer useful or even accurate services.

To help in the decision-making process, the National Society of Genetic Counselors has just released a list of questions consumers should ask when selecting a genetic testing service:

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Navigenics is pleased to announce the appointment of a new company leader. Here are some details, as described in a news release:

Navigenics, a leading personal genomics testing company, announced today that Jonathan “Jack” T. Lord, M.D., has been appointed by the Board of Directors to serve as President and Chief Executive Officer of the firm.

Dr. Lord brings to Navigenics a history and passion for combining robust medical science with technological innovation to improve consumers’ health and access to quality care. Dr. Lord comes to Navigenics from Louisville, Kentucky-based Humana, Inc., where as Chief Innovation Officer he was responsible for designing new products and services to enable people to navigate the healthcare system and support their health needs.  Before Humana, Dr. Lord was president of Health Dialog in Boston, where he helped pioneer e-enabled health care. He has also served as chief operating officer of the American Hospital Association in Washington, D.C.  Previously, Dr. Lord was executive vice president of Anne Arundel Medical Center in Annapolis, MD, and executive vice president of Sun Health in Charlotte, NC.

“I am excited about the prospects of leading a company that will transform healthcare. Navigenics’ leadership in science, its exceptionally committed and leading edge investors, and strong management team make this the most exciting opportunity of my career,” said Dr. Lord.  “Passion for advancing personalized medicine defines Navigenics.  I am very honored to have the privilege to lead this company as we transform healthcare for the 21st century– an era of healthcare we hope will be marked by a focus on prediction and prevention.”

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“This is not going to be your typical story about Alzheimer’s disease,” explained Nightline co-anchor Terry Moran. “…You get to come to my office and watch me spit in a tube.”

And so began Moran’s personal tale of his quest to discover whether Alzheimer’s disease might one day control his life, just as it had his mother’s not that many years ago.

By spitting into a special tube and shipping his saliva sample to Navigenics, Moran was able to experience first-hand one of the greatest breakthroughs in modern medicine – the ability to size up his genetic code and learn his personal genetic risk for a disease he has long abhorred.

“My moment of truth,” he told the cameras, as he prepared to get the results of his Navigenics genetic test. “I wanted to face my fears...”

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It’s always nice to be recognized. Being called one of the “Fabulous Four” Bay Area businesses by a leading business columnist? Even better.

San Jose Mercury News writer Chris O’Brien recently featured Navigenics in his write-up of Bay Area companies that are succeeding during this global economic downturn. His profile is a pleasant acknowledgement of all the hard work that has gone into creating the genetic testing service that is most recommended by physicians. 

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Just what is genetic testing and how can it help your health?

Tune into “The Doctors” show on television today and you’ll get answers.

The show’s “Secrets to Living Longer” episode – which will air at 4 p.m. on Fox in many media markets – features the Navigenics genetic testing services.

Learn how a simple saliva test can help you determine whether you are genetically predisposed to certain diseases such as colon cancer, diabetes and Alzheimer’s disease. The tests can enable you and your physician to come up with a personalized health plan to prevent the conditions, delay them or detect them early.

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Navigenics is pleased to announce the acquisition of a clinical testing facility for our genetic testing services. I’d like to share the details about this exciting opportunity, as described in a news release issued today:

Navigenics, a leading personal genomics testing company, announced today the acquisition of the Affymetrix Clinical Services Laboratory, a CLIA-certified testing facility that provides molecular genome scanning using the Affymetrix GeneChip® microarray platform. With the purchase of this testing facility, Navigenics can now offer fully integrated genome screening and analysis under one roof.

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With so many new genetic discoveries, technologies, and applications, the number of companies offering genetic testing has skyrocketed over the past few years.

As a genetics professional, it is incredibly exciting to me that the genetics field is becoming more accessible to more people.

But not all genetic tests are the same, and not all genetic testing companies offer accurate and useful services. How is a person to sort through all the options to make an informed decision?

Now, an independent lab testing group has made it easier to decide…

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Step away from the couch. Put down that remote control.

Engaging in even a modest amount of exercise (just 74 minutes per week!) has been associated with a significant improvement in quality of life among middle-aged women, a new study shows.

It’s not exactly a secret that exercise has a myriad of health benefits. But what scientists found in a six-month study may surprise you.

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Cancer deaths among African-Americans have been steadily declining in recent years, but are still much higher than they should be.

For most types of cancer, blacks continue to have the highest death rate – and shortest survival – of any racial or ethnic group in the United States, the American Cancer Society reported recently in a sweeping review of African-Americans and cancer.

All too often, when cancer is diagnosed in an African-American patient, the disease is more advanced and harder to beat, the scientists found.

The issue has more to do with social and economic disparities – and a lack of early screening – than any biological differences associated with race, the scientists concluded. Inequalities in wealth, education and health insurance are partly to blame.

But cancer also is not being detected early enough.

As a result, more than 63,000 African-Americans will die from cancer this year.

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Navigenics, a leading personal genomics testing company, announced today it has developed an innovative physician-focused online portal allowing doctors to access the genomic information of consenting patients. For patients choosing to receive a Navigenics service through their physician, this portal allows the physician to integrate patients’ genetic information into personalized health plans designed to help diagnose early or prevent a number of health conditions. Accessible through Navigenics’ website, the secure portal empowers physicians with a suite of tools including a single access point to all of their participating patients’ genomic information, along with learning tools and case studies for integrating genomic information into their clinical practice.

Navigenics also announced that it has expanded its portfolio of DNA testing services by offering a new service that provides a lower cost of entry into genetic health. Called Navigenics Annual Insight, the new service is available for $499 and mirrors many of the hallmarks of the company’s flagship product, Navigenics Health Compass, and provides information on an individual’s genetic predisposition for common preventable health conditions.

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Navigenics is pleased to announce a new relationship with a national network of physicians who practice proactive, personalized medicine. Through the collaboration, the Navigenics genetic testing service will be made available to their patients, who number more than 100,000 nationwide. I’d like to share some of the information about this collaboration, as described in a news release issued today:

National Physician Group MDVIP Partners with Navigenics to Provide Personal Genetic Tests for Preventive Medicine Practice

Boca Raton, FL and Redwood Shores, CA – December 8 2008 – MDVIP, Inc., a leading national network of physicians dedicated to preventive and personalized healthcare, and Navigenics, Inc., a leading personal genomics testing company, today announced a first of its kind collaborative effort to integrate genomic-based preventive healthcare in physician offices. Through this initiative, Navigenics’ genomic testing service will be available to MDVIP affiliated physicians to help patients understand their genetic risk factors for disease and work with their doctors to develop individualized prevention plans.

Navigenics will provide MDVIP patients and their affiliated physicians with insight into their personal genetic predisposition for developing certain medical conditions where primary or secondary prevention could improve health outcomes. The Navigenics test will identify individuals’ genetic markers for developing such conditions as type 2 diabetes, cancer, heart attack, and celiac disease. Working with their personal MDVIP physician and Navigenics’ board-certified Genetic Counselors, individuals can chart and implement a personalized wellness course to help decrease their overall risk, delay disease onset or prevent it altogether.

“We have for many years been closely watching the field of genomic testing evolve into a tool that can enhance and inform the practice of preventive medicine,” said Edward Goldman, M.D., CEO of MDVIP. “We believe that Navigenics’ preventive genomics service has the potential to be an innovation that could significantly enhance patient care.”

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As we pointed out in our blog a few weeks back, the Scripps Translational Science Institute has launched an ambitious 20-year study on how people respond to genetic test results, using the Navigenics service as a basis for the research.

Upon learning they are at increased genetic risk for conditions such as obesity, diabetes or cancer, do people start to exercise more and eat a little less? Are they more conscientious about going to the doctor at the first sign of trouble? Do they ignore the information entirely, refusing to kick their pack-a-day habit?

Previous smaller studies have found that genetic information holds promising motivational potential. Now, the Scripps study’s principal investigator, Dr. Eric J. Topol, plans to follow 10,000 adults to find out more.

He already has one very important set of results in hand—his own.

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Today, Navigenics is pleased to announce our participation in a major study that will examine how people respond to personal genetic testing. Here are some details of this research endeavor, as described in a news release:

A consortium of health care, technology and research leaders have joined forces in a first-of-its-kind research study to assess the behavioral impact of personal genetic testing on people who choose to receive such screenings to identify their potential risk for developing certain diseases.

Sponsored by Scripps Translational Science Institute (STSI), the study aims to find out if participating in personal genomic testing will improve health by motivating people to make positive lifestyle changes, such as exercising, eating healthy and quitting smoking, as well as decisions to seek further medical evaluation and preventive strategies.  The study will offer genetic scans to up to 10,000 employees, family members and friends of the nonprofit Scripps Health system in San Diego and will assess changes in participants’ behaviors over a 20-year period.

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In an era when new DNA discoveries are announced daily, it often seems like the amount of genetic information we now have about ourselves is endless. Quantity, however, isn’t always the same thing as quality.

While genomic science continues to uncover fascinating details about our DNA, some of those findings are more useful than others. It may be interesting, for example, to learn whether you share a sprinter’s genetic propensity for speed. It’s important, however, to know whether you carry a high genetic risk for heart attack.

In our genetic health service, Navigenics analyzes only DNA relevant to your health.

To be added to our gene test panel, a health condition and the science behind it have to meet strict rules:

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You have heard of the elderly. But how about the “wellderly”? The moniker is now being used to describe healthy seniors over the age of 80 who have been fortunate enough to live long – without any chronic diseases or the assistance of long-term medication.

What’s their secret? Scientists would like to know, too. In southern California, a group of researchers has launched the “Wellderly Study” to analyze the genes of some 1,000 healthy octogenarians, nonagenarians and centenarians. The researchers hope that by exploring the DNA of this long-lived group, they will have a better understanding of the genetics behind longevity and lifelong health.

For the Wellderly project, Scripps scientists will compare the DNA from healthy seniors with DNA taken from seniors who died from common diseases such as cancer, heart attack and stroke before they made it to 80. This second group has been dubbed the “Illderly.”

Many of the wellderly, the scientists note in the journal Nature, do have genes that should have made them susceptible to diseases – yet they’ve still managed to stay healthy.

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As a physician with many years in private practice, I’ve always valued tools that helped me care for my patients on an ongoing basis. Everyone’s health is prone to vary over time, so there is definite benefit to new science that highlights change.

That’s why a key aspect of the Navigenics genetic health service – ongoing updates – is so important. When Navigenics analyzes a person’s DNA, the findings don’t stop with that first genetic report. As new genetic research findings pass our rigorous scientific scrutiny, we bring our members additional information about their current conditions and new ones.

This process means that our members’ DNA results stay current with the latest and best genetic science.

This week, we’ve started providing our members their personal genetic insights into two additional conditions:

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The Navigenics genetic testing service can be experienced one of two ways – through test results you order yourself, or through a test ordered for you by your doctor. While that second option clearly means more physician involvement from the start, it doesn’t change the need for your participation in the genetic process.

Your DNA is still just that—your DNA. To understand it thoroughly, your physician needs your input.

Even if your physician ordered your Navigenics Health Compass report for you and plans to explain your results, the very personal nature of DNA analysis means there are important steps you should take before your doctor’s visit. Your discussion with your physician will be more productive if you gather some personal information before your results review.

This preparation is somewhat different from the physician-related steps we recently recommended for Navigenics members who’ve ordered their own Health Compass reports.

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This week, we’re pleased to share an important piece of news about the work we do in our home state. After working closely with California regulators to satisfy all of their questions about our genetic health service, Navigenics has received a state license signifying our full compliance with the state’s laboratory requirements.

When news first appeared of the state’s inquiries earlier this summer, some observers wondered if our discussions with the state might prove challenging, requiring changes in the ways we offer our service or think about the health potential of DNA analyses. We didn’t focus on those concerns.

Meeting regulatory requirements has been a central part of Navigenics from the very beginning, and we have been intent on working closely with both state and federal regulators to address any issues. When questions arose in California, we were more than prepared to meet them. Along the way, state officials were incredibly responsive. They worked quickly to help us resolve the licensing issue.

This outcome in California is great news. But we also know that it is only the first step. Many important questions about the new field of personal genetics still need to be addressed at a national level.

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An apple a day isn’t enough anymore. Now you also need to think fish or flaxseed in your diet to help keep the doctor away. That is why Navigenics has new recommendations to encourage our members to be sure they get enough omega-3 fatty acids in their diet.

Omega-3 fatty acids aren’t snake oil, promising to cure all ills; rather, they are oils from fish or certain nuts and plants, and researchers have found strong evidence that they have many potential health benefits.

These polyunsaturated fatty acids are found primarily in fish and fish oils, but also in some plant-based oils, such as canola oil or flaxseed oil, and certain leafy green vegetables, including spinach, kale, broccoli and seaweed.  They are essential to human health, but cannot be made by the body. That is why it is so important for people to make sure they get sufficient amounts of them through diet or supplements—and to know how much they need.

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For anyone needing to lose weight (and who doesn’t these days?) comes welcome new research showing there is life – and weight loss—beyond the low-fat diet.

The popular Mediterranean diet is a safe and effective alternative to the low-fat plan often recommended by physicians, Israeli researchers determined in a two-year-long study published in July in the New England Journal of Medicine.

While people who stick with almost any diet lose weight, those on the Mediterranean diet lost a significant amount – almost 10 pounds, compared to about six pounds for those on a low-fat diet. And the Mediterranean diet, in particular, was praised by the scientists because it is high in fruits, vegetables and fiber, all of which are beneficial for health.  Previous research has shown it is good for the heart, and may even reduce the risk of developing Alzheimer’s disease.

What is a Mediterranean diet?

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Last month, I blogged about a concept getting more attention in weight and health – the size of your waist may be even more important than the number on the scale.  Now, two recent developments further highlight that point. 

In that last post, I talked about a powerful study from the Mayo Clinic on a phenomenon called “normal-weight obesity.” That research indicated that more than half of American adults not considered overweight by regular standards such as Body Mass Index actually had high body-fat percentages, especially in their midsection. Those with wider waists also had higher rates of heart and metabolic risk factors.

Recent news illustrates that more findings support that idea. After looking at the health records of more than 20,000 people, researchers at Ohio State University spotted similar problems.

People included in the study who were not considered formally overweight but had a “marginally increased” waist circumference were much more likely to have high blood pressure than those with slim midsections. The scientists determined that adults with “normal” weights but a wide waist have an increased risk of cardiovascular problems. 

In other words, Americans need to get a handle on their love handles.

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Common genetic variants and the role they play in breast cancer have been popular topics in scientific journals lately.  I recently mentioned a new study in the New England Journal of Medicine that found women with 14 of the genetic markers associated with breast cancer had 6.3 times the risk of breast cancer as women with none of the markers.  “A few susceptibility alleles may distinguish women who are at high risk for breast cancer from those who are at low risk,” the study determined.

Now comes more research that supports the notion that analyzing a woman’s genes can be a useful weapon to add to the arsenal physicians and patients have in the battle against breast cancer.

Scientists had already established that there are several environmental links to breast cancer, including a woman’s age at first period, her family history and current age. Recently, researchers have had the tools to start identifying the other pieces of the puzzle – genetic risk factors. 

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When people interested in Navigenics hear that genetic counseling is a core part of our service, they usually have two things to say. The first is “Great!” The second is “What do you do, exactly?”

Here is a look at who we are, and how we can help you make the most of your genetic insights.

Genetic Counselors are highly trained health professionals with specific expertise in medical genetics and counseling, but many people have never had access to us. That separation reflects the traditional role of genetic information in health care. For a long time, genetics focused mostly on either rare diseases or pregnancy. As a result, you might have been referred to a Genetic Counselor only if a rare condition ran in your family, or if you were considering a genetic test as part of having a baby.

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I recently had the opportunity to hear the CEO of the American Cancer Society, John Seffrin, Ph.D, speak at the Aspen Ideas Festival. In listening to Dr. Seffrin, I heard him convey many of the same beliefs that we have here at Navigenics – primarily the benefits of early diagnosis and prevention.

There were two key data points which Dr. Seffrin mentioned: (1) many cancers are “curable” if found in Stage 1, and (2) that nearly 60-70% of all cancers are preventable. He also noted that prevention, through behavior change and early detection, is our best known “cure” today.

This is exactly the idea behind what we are doing at Navigenics – by helping you identify your genetic risk for a disease, before you start showing symptoms, you can catch it early, treat it early, or perhaps prevent the disease from occurring altogether. 

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When the scientific debate over personal genetic services got a little heated in March, scientists at Navigenics decided to weigh in with our own perspective. Our response is now in print—and the conversation continues.

This particular debate started when prominent federal and international scientists published an article in the American Journal of Human Genetics, criticizing the personalized genetics industry. The study’s authors discussed a number of personal genomics companies, and mentioned Navigenics briefly. The bulk of the study, however, focused on the genetic associations used by seven other personalized genetics companies – a lineup that did not include Navigenics – and found weaknesses in their scientific underpinnings. The researchers further claimed that there isn’t enough scientific evidence to make genomic profiles useful in measuring common disease risk or developing steps for disease prevention.

Scientists at Navigenics read the study, and wanted to set the record straight. 

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If you’re a woman in your 20s or 30s, you probably haven’t had a mammogram. The people who calculate the need for medical tests figure it’s not worth it to screen most women at such a relatively young age.

But if you already knew, from your genes, that you were at elevated risk for breast cancer, you might feel differently. Now, some researchers feel differently about it too.

Researchers at the University of Cambridge found that women with 14 of the genetic markers associated with increased risk of breast cancer had about six times the risk of breast cancer as women with none of the markers. They recently reported their findings in the New England Journal of Medicine.

Their research could mean a big change in the timing of cancer screening for some women, as well as the ways doctors detect early signs of the disease.

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DNA took to the prime-time airwaves last week, when the acclaimed PBS program NOVA scienceNOW looked at the topic of personal genetic services. Navigenics was featured prominently in the segment. Dietrich Stephan,our co-founder and Chief Science Officer, sat down with host Neil deGrasse Tyson to explain how the process works. After Tyson chose to explore his own DNA using the Navigenics service, Elissa Levin, our Director of Genetic Counseling, helped Tyson understand his results.

The segment offers a balanced look at genetic services, addressing some of the broader critiques about genetic testing head-on. We are honored that a scientist such as deGrasse Tyson, a prominent astrophysicist, weighed those concerns and still saw the value of revealing his own DNA insights.

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The field of personalized medicine is filled with many players, each with its own approach.  Physicians considering the Navigenics genetic health service often ask me if we follow best practice guidelines set forth by leading professional societies. My answer is a clear “Yes.”

Leading medical genetics societies, such as the American College of Medical Genetics, the American Society of Human Genetics, and the National Society of Genetic Counselors, have laid out clear standards for the field of personal genetic services. These industry leaders usually describe our field as “direct-to-consumer” genetics, meaning that individuals may access these services themselves, rather than being required to seek a test through their doctor.  And these groups want to make sure individuals who turn to these services receive high-quality care.

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Genetic testing has been making headlines recently, but not just for the promise it holds for boosting health. Instead, regulatory issues in the state of California have been at the forefront of the news. State health officials recently sent letters to more than a dozen genetic testing firms, including Navigenics, asking each to stop providing services to customers.

At issue is whether genetic testing companies adhere to California’s clinical laboratory licensing laws.  Here at Navigenics, we believe we do, and we will work diligently with both state and federal regulatory agencies to clarify any misunderstandings.

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Since its inception, Navigenics has been driven by the vision of improving health outcomes. The feedback from our members is exciting. Over the last few months we have heard from those discovering colon cancer risk and then finding polyps, discovering glaucoma risk and then discovering elevated eye pressure, discovering celiac disease risk and then getting a positive diagnosis, and many others. 

We are at the very early stages of the new era of predictive genomics and personalized medicine.  There are many voices, there is much debate and there is great dialogue.  As part of furthering that discussion, today we are pleased to announce the launch of our official company blog, The Navigator. Through this blog, we hope to add our voices more regularly to the dialogue on genes and health. We also want to create the opportunity to get more of your feedback and add your voices to the discussion.

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