Press release

Committee on Energy and Commerce
Subcommittee on Oversight and Investigations
United States House of Representatives Hearing on
Direct‐to‐Consumer Genetic Testing
And the Consequences to the Public Health
Written Testimony of
Vance Vanier, M.D.
Chief Executive Officer
Navigenics, Inc.
July 22, 2010

Chairman Stupak, Ranking Member Burgess, and Members of the Subcommittee, thank you for the opportunity to testify on the important role that personalized genetic testing can  play in prevention and wellness with the overall goal of improving public health.    

 

I am Vance Vanier, M.D., Chief Executive Officer at Navigenics, a genetic testing  company based in Foster City, California.  I am trained in emergency medicine and have worked on the front lines of patient care where I have observed first‐hand the overwhelming need for new preventive technologies.  I continue to serve on the clinical faculty of Stanford Medical Center, received my medical degree from the Johns Hopkins School of Medicine and completed my residency training at the University of California, San Francisco, and Highland Hospital in Oakland, California.   

 

We welcome the Subcommittee’s interest in personalized genetic testing, which is rooted in a long history of congressional promotion of innovation and balanced, science‐based regulation.  From the 1975 Asilomar Conference on the regulation of recombinant DNA (rDNA) research through this Committee’s biotechnology hearings led by Chairman emeritus Dingell and then‐Subcommittee Chairman Waxman in the 1980s, to the recent, extraordinary success of the historic Human Genome Project, Congress has worked collaboratively with regulatory agencies, academe and industry to create the conditions that allow American researchers and companies to lead the world in creating new life‐saving and life‐improving health solutions.  

 

Mr. Chairman, Navigenics is a company that simply would not exist without the long-term commitment to the Human Genome Project that this Committee and this Congress made and sustained.  As you know, the Human Genome Project was an unprecedented 13‐year, $3 billion project completed in 2003, coordinated by the United States Department of Energy and the National Institutes of Health (NIH).  Our co‐founders, and each one of our dedicated employees at Navigenics, have been committed to pursuing the scientific possibilities created by the first complete mapping of the human genome, which NIH rightly described as one of  “the great feats of exploration in human history, an inward voyage of discovery rather than an outward exploration of the planet or the cosmos…which has given us the ability, for the first time, to read nature's complete genetic blueprint for building a human being.”   

 

Achieving this spectacular goal, and opening the door to the promise of personalized health and medicine, led David Agus, M.D., a leading oncologist, and Dietrich Stephan, Ph.D., a leading human geneticist, to found Navigenics in 2006.  The company’s overall goal is to improve health outcomes in individuals across the population. Navigenics educates and empowers individuals and their physicians with knowledge of their genetic predispositions, and then motivates them to act on the information to prevent the onset of disease, achieve earlier diagnosis, appropriately manage disease, or otherwise lessen its impact.  

 

Navigenics offers clinically‐guided personal genetic analysis exclusively through two professional channels:  1) medical centers and physicians, with clinical research partners like the Mayo Clinic, Duke Medicine, Scripps, Cleveland Clinic, the American Academy of Private Physicians, and MDVIP, the nation’s largest network of physicians practicing preventive and personalized healthcare, and 2) as a benefit through employer wellness programs at Fortune 100 companies. Progressive companies who wish to promote prevention awareness have offered the Navigenics Health Compass to employees as one tool within a broader health and wellness program without ever gaining access to their employee’s personal genetic data. It is important to note that consumers currently cannot enroll in Navigenics services simply through visiting our website. Navigenics will only test consumers who confirm that they are over the age of eighteen.  

 

We firmly believe that a healthcare professional should be an integral part of the personal genetic analysis process, which is why we have our own team of genetic counselors who are available to educate and support both healthcare providers and our customers. Each of our genetic counselors is board certified by the American Board of Genetic Counseling and has received extensive specialty training in personal genomic counseling. All individuals who are interested in testing or have received genetic testing through Navigenics have access to these genetics experts to address questions and enable informed decision‐making.  Our members’ personal physicians have unlimited access to our staff of genetic counselors as well. It is worth noting that these professionals adhere to a rigorous set of bioethical standards and receive no incentives to guide individuals to test when it may not be appropriate. Every individual who chooses to test with Navigenics is personally contacted to schedule a genetic counseling consultation to discuss the results, identify resources, and facilitate the dialogue with their healthcare providers. The majority chooses to engage in this service and report feeling empowered and better informed by the interaction.   

 

Over the past three years, a fundamental focus of our service has been developing physician education programs and clinical tools to facilitate clinical integration for both private and corporate physicians.  Navigenics’ genetic counselors focus a significant portion of their efforts on working with physicians to provide end‐to‐end support from basic education to clinically‐guided information about specific patient results in the context of their personal and family history. The Navigenics Physician Portal is a security‐enabled, centralized tool that enables ordering physicians to receive and manage their patients’ Navigenics results and access ongoing clinical updates.  

 

Unlike other companies that test for untreatable and degenerative diseases, such as Lou Gehrig's Disease (ALS), or traits such as eye and hair color or ancestral lineages, Navigenics solely focuses on medically‐relevant health conditions and medication sensitivities that can help motivate behavior change and inform healthcare decisions in conjunction with a healthcare provider. Identifying an individual’s genetic risk for common conditions like celiac disease and heart disease, or an increased likelihood of having an adverse reaction to a specific medication, can help them take action towards improved health. Additionally, we provide extensive health information in patient‐friendly language.  Navigenics thereby provides a foundation of highly‐vetted resources on key prevention steps and established medical guidelines that can help avoid or lessen high morbidity chronic illnesses such as diabetes, heart disease, and high blood pressure.  All of these afflictions, as you know, alone lead to seven in ten deaths in the United States and a staggering 75 percent of our national health care costs.  

 

Navigenics operates in full compliance with all existing state and federal regulations and is the only consumer genomics company that is approved by state regulators to operate in every state, including the state of New York.  We own and operate our own CLIA‐certified laboratory in West Sacramento, California, which is currently regulated by CMS.  We are dedicated to maintaining the privacy and security of all of our customers’ genetic information, never selling nor sharing individuals’ personal genetic information with third parties and ensuring that all of our all our operations are consistent with the Health Insurance Portability and Accountability Act (HIPAA).   

 

Personalized genetic testing is already demonstrating significant value for individual consumers and patients.  At an historic time when our country has passed healthcare reform to systemically address our health crisis, we have been counseling one patient at a time on strategies they may wish to consider discussing with their doctors in the pursuit of improved health.    

 

Over the past several years we have worked with a broad range of individuals in which personal genomic testing positively impacted their health – whether it be from early identification of macular degeneration that resulted in halting visual loss before it progressed, to initiating and maintaining long‐avoided lifestyle modifications to minimize the risk for diabetes and cardiovascular disease, to helping a physician select the right type of statin to yield the desired therapeutic effect.  The promise of personalized medicine is not yet fully realized, but both patients and providers have already experienced its beneficial effects.   

 

We are seeing positive results not just on an individual basis and within our partner groups but also within study populations.  In cooperation with Eric Topol, M.D., of the Scripps Research Institute, Navigenics launched the Scripps Genomic Health Initiative (SGHI) in October 2008.  This research study, independently approved by Scripps own Institutional Review Board (IRB) is the first large‐scale research study in our country to assess consumer response to personalized genomic risk assessment over a period of 20 years.  Early results from have indicated that customers are eager to learn more about their genetic predispositions to disease and do not show increases in anxiety or distress after receiving their results.  A total of 82.4 percent respondents indicated that they would want to know their genetic risk and over 80 percent said they would recommend genetic testing for friends and family.  Along with the research team in Dr. Topol’s lab, we will be eagerly awaiting and analyzing the results from this—and other relevant studies—in the future.  

 

These are just some of the meaningful benefits emerging within personalized medicine.  Customized therapies are becoming “best practices” in hospitals, ensuring patients receive optimum treatment from the start of care.   This been particularly effective for cancer treatment, but personalized medicine is also is informing treatment for cardiovascular disease, infectious disease, psychiatric disorders and transplantation medicine.   

 

These benefits are accruing on personal as well as financial fronts. For example, genetic testing is performed to properly dose the blood thinner, warfarin. If this testing were accomplished for all patients in the United States at a cost of $125‐$500 per test, the approximately 17,000 strokes, 85,000 serious bleeding incidents and as many as 43,000 emergency room visits could be avoided.  This alone could represent a savings of $1.1 billion annually. We know that many drugs are only effective for 50 percent of patients for whom they are prescribed.  Not only is genetic testing widely utilized with breast cancer patients to ensure that they receive the appropriate drug, but these technologies reduce trial‐and‐error prescribing. Personalized medicine also allows providers to minimize the side effects of drugs, increasing patient compliance.  This is particularly important for conditions like asthma and diabetes, which are exacerbated by patient non‐compliance.  

 

We stand at a critical juncture in our country’s ability to realize the true potential of personalized medicine and of the landmark Human Genome Project.  While our nation’s human and financial resource investments to date have yielded impressive genomic information and data, the true value of this monumental project will be in how this knowledge will be applied in improving the quality of life and health of all Americans.  Furthermore, our own national leadership in the life sciences is at risk.  Abrupt or overbroad regulation can chill genomic discoveries and applications in this country, driving innovation and investment to other countries and attracting with it thousands of high value jobs in this key growth industry.  

 

At issue is the best regulatory pathway for services like ours. As you know, just this week, the Food and Drug Administration (FDA) began a comprehensive process of reviewing regulatory approaches to laboratory developed tests (LDTs) with a two‐day public meeting.  At the same time, the FDA is being criticized for, and is undertaking self‐scrutiny of, the rigor and appropriateness of the entire medical device premarket clearance pathway, under section 510(K) of the Federal Food, Drug and Cosmetic Act, which potentially applies to LDTs.    

 

Despite this continuing uncertainty, we have pursued a proactive dialogue with the FDA for more than three years, and we continue to welcome balanced federal oversight. Even before we launched our service, Navigenics was a leader in encouraging collaboration, dialogue, and compliance with regulatory authorities – at both the state and federal levels – and in seeking to develop uniform standards for the industry’s technologies and services.     

 

Navigenics has been a leader in working with industry groups, patient advocates, and other interested parties in promoting industry standard‐setting and encouraging the cooperation of our industry colleagues. Because genotype‐based risk prediction for common, multifactor diseases is an area of continued innovation, more work must be done to standardize markers used; to better explain the contribution of genetics to common, complex diseases; and to incorporate common genetic variants into clinical practice. We are happy to provide the Subcommittee with additional information regarding these important efforts to assure and strengthen the transparency and standards in our important new sector.  

 

Mr. Chairman, we have great confidence in the government’s ability to find a balanced path forward—one that allows for innovation while protecting the public.   We are, of course, committed to complying with any and all regulatory requirements as the Agency, States and Congress work towards an effective consensus. Congress has already succeeded in protecting personal genetic data through enactment of the Genetic Information Non‐Discrimination Act in 2008, which prohibits the improper use of genetic information in health insurance and employment. We believe this Subcommittee can help assure the same information is protected and safely applied in the service of safeguarding human health. 

 

To this end, we would support the creation of an outside advisory committee to guide the FDA as it determines how to regulate LDTs and personal genetic testing services.  This week’s public meeting should be just the beginning of an open dialogue with the community of stakeholders that will be critical to the Agency’s ability to reach consensus on the best way forward.  A major hurdle for us and other test developers has been the lack of clarity about the process.  This lack of clarity has affected our ability to maintain and grow our business.  The economy is still in a fragile period and the federal government should continue to pursue policy that will help small businesses grow and generate new high skill and high wage jobs, and speed our economic recovery.  

 

Mr. Chairman, thank you for the opportunity to testify today.  Personalized genetic testing offers important benefits in strengthening prevention and wellness, improving health literacy, and reducing health care costs for the American public.  I urge this Subcommittee and Congress to work closely with the FDA, academic scientists, and companies like Navigenics, to develop reasonable, risk‐based and science‐based standards that will assure the continued availability of innovative health services like personalized genetic testing.