The Center for Data innovation spoke with Rick White, co-founder and chief architect of Sure Genomics, a consumer genomics company based in Carlsbad, California. White discussed how federal regulations can struggle to keep up with new technologies as well as how to make genetic data usable to the average consumer.
This interview has been edited.
Joshua New: Sure Genomics is one of the handful of direct-to-consumer genetic testing companies that have sprung up in recent years. Why do you think this field exploded so quickly?
Rick White: Affordable whole genome sequencing was the huge breakthrough. Now that the whole genome is accessible, we can round out our health portfolio with personal genetic information to better predict our disease risks and work with our doctors to institute preventive measures to either prevent or decrease the impact of our disease risks. Another important factor is that medical science as a whole has learned a great deal about the underlying causes and treatments for disease and dysfunction, and researchers share their data and results on public databases such as ones operated by the National Institutes of Health (NIH). The combination of this abundant data coupled with the decreasing cost of full DNA sequencing can help stop the cycle of reactive response to illness and move us towards proactive health. My hope is that in the next decade everyone has their genome sequenced and makes that information the foundation of their electronic health record. However, we believe access and understanding are both essential. We designed a new model for delivery that matches the way we like to browse and explore all our content like our news, music and entertainment to increase understanding and make the experience enjoyable.
New: The Food and Drug Administration (FDA) has heavily scrutinized the direct-to-consumer genomics market, and in February 2016 sent Sure Genomics a letter questioning some of your business practices. What kind of regulatory obstacles exists for companies in this space? Do you think the FDA has taken the right approach thus far?
White: We’re in new and exciting territory for advancing proactive health and precision medicine. We’re also in a situation where consumer demand and technology breakthroughs are outpacing existing regulatory approaches. The most successful companies will work with global governments and their regulatory agencies to get it right. It is our opinion that the best thing that companies, ourselves included, can do is to engage with healthcare regulators, like the FDA, and have ongoing discussions to insure that they are delivering a solution that provides a safe and productive solution for everyone.
We think that the 21st Century Cures Act is a big step forward and if signed into law will help free the FDA to work more efficiently with genomics software companies. We believe every consumer has the right to gain access to their genetic information and believe the debate is in our favor.
New: Can you discuss Sure Genomics’ recent partnership with chronic disease management firm Sanitas?
White: We saw a great opportunity to incorporate reliable disease risk information with genetic information. Both our companies want to help people be better informed about their health risks. By partnering with Sanitas we can offer consumers the only FDA-cleared service that screens for six major diseases including heart disease, stroke, diabetes, and colorectal, breast and ovarian cancers. The service is called Family Healthware and it’s a simple self-administered questionnaire you take online on the Sure Genomics website that collects health data, behaviors, recent lab tests, and family health history.You simply take the test, assess your risks, and you also have the option to get your entire DNA sequenced from the same platform.
New: Sure Genomics sequences customers’ entire genome, unlike most consumer genomics companies which only examine specific portions of a genome or just specific mutations. Why take this approach?
White: Our service, called SureDNA, sequences the whole genome and stores the information in our HIPAA-compliant storage system called SureVAULT. Similar to your smartphone, only the user will be able to decrypt the data. We use the entire DNA sequence as foundational data for every consumer. Our strategy is to provide the full sequence once and compare that data against new genetic information and insights maintained in national databases and provide our customers with dynamic reports every six months. We believe this practice of “one test, a lifetime of discoveries” could transform consumer health and the cost of healthcare. For example, your genes can tell you how well your body interacts with drugs. With your entire genome accessible you now can check how well you metabolize a drug before fulfilling that prescription.
New: A whole genome is a very large amount of data. How do you go about managing all of this information and still make it available to customers in a usable fashion?
White: You have to consider that much of the science of genetics is confusing to consumers so we made it our mission to be the last mile and provides a lens that makes it easy and even enjoyable to explore your genetic information. We overlay your genetic variant information on a virtual image of the male or female human body. For example, the genomic information indexed to markers related to the leg will be accessible by clicking on the image of the leg in the interactive feature. Done right, we believe we can learn from our genetics to reduce our weaknesses and amplify our strengths.