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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