23andMe, a consumer-level genetic testing company, launched the consumer genomics movement with a bang. But in late 2013, regulatory setbacks forced it to stop marketing its direct-to-consumer genetic test kits. The hiatus lasted until three months ago, when the company received FDA approval to restart sales of its “personalized genetic reports.”
Speaking on a panel at the JPMorgan healthcare conference in San Francisco, 23andMe CEO Anne Wojcicki expressed optimism, noting that the world is a different place when millions of people walk around with better knowledge of their personal health risks.
The goal – and the companies – aren’t new. Wojcicki’s 23andMe was founded nearly ten years ago and has received over $200 million to bring genetic testing to the masses. While newer to the genomics game, AncestryDNA’s parent company, Ancestry.com, has been in the family history business for over thirty years.
But for consumer adoption of genetic testing services, these are still early days.
Concerns about consumer interpretations of test results, privacy, and the specter of more regulation are potential roadblocks. Despite those, consumer genomics companies believe they will revolutionize how we manage healthcare. Could now be the time we see exponential growth?
Alliances Forming
It’s clear that even the top consumer genomics players don’t believe they can master the universe alone. Many of the companies spent 2015 lining up dance partners – big, powerful dance partners.
In January 2015, 23andMe announced a partnership with Pfizer, giving the company access to its research platform. It also partnered with Genentech in early 2015 to identify new treatments for Parkinson’s disease.
Six months later, Google’s Calico Life Sciences launched a partnership with AncestryDNA to analyze and investigate genetics and longevity using Ancestry.com’s databases. AncestryDNA sells test kits for $99 for consumers to discover their family genetic history.
Helix, a start-up launched by Illumina (NASDAQ: ILMN) in August 2015, has already partnered with Mayo Clinic and Laboratory Corporation of America (NYSE: LH), the largest clinical diagnostic lab company in the U.S., and announced partnerships with Good Start Genetics and Duke University.
Obama’s Precision Medicine Initiative (PMI)
Another step forward: in January 2015 President Barack Obama called for the government to assemble a research cohort of 1 million Americans. The program provides government validation for a core principle underlying direct-to-consumer genomics: that individuals should have access to their own genetic data.
PMI ought to be positive for accelerating science, but the program has its shortcomings. For example, it is expected to take four years to generate the list of participants. Takeaways from PMI studies may not emerge for almost a decade.
Critics argue that there are other government databases – the Million Veteran Program, for instance – that the government ought to be utilizing. In addition, there are thoughtful organizations, like Mayo Clinic, spending more dollars per year on personalized medicine than the entire PMI (funded with $215 million in 2015).
However in a twist from typical government initiatives, the president’s program mandates that the 1 million cohort receive their own health information, making this a program with active research project participation.
The genomics industry is generally excited about such a wide-scale controlled study and the information it may yield, noting there could be a role for public-private partnerships over time.
Regulatory Outlook Uncertain
23andMe is in the middle of a regulatory reset, having obtained FDA approval to provide a limited amount of health data. It is trying to gain FDA approval for a larger subset of the information it previously provided to consumers. Now, the consumer genomics industry is watching the FDA regulatory landscape of direct-to-consumer genetic tests.
Some in the genomics industry believe that the FDA process for consumer genomics is relatively reasonable, but others feel FDA pushing harder on more regulation — particularly with Lab-Developed Tests, or LDTs.
The question for the consumer genomics industry is whether it will continue to be able to develop tests rapidly. Innovation on the software side also tends to be difficult to regulate under any FDA framework.
FDA’s Alberto Gutierrez’s recent comments at an industry conference may indicate a more paternal view of regulating DTC genetic tests. Dr. Gutierrez, Director of the Office of in Vitro Diagnostics and Radiological Health at FDA, spoke on a panel recently where he criticized DTC genetic testing, comparing those customers to “anti-vaxxers,” individuals who do not believe in childhood immunizations.
The FDA director has expressed concerns with the interpretation of genetic test data, and consumers potentially making health decisions based on inaccurate information.
Consumer Empowerment & Declining Costs
Market research shows that consumers want healthcare information transparency, and generally want to be involved. The government-funded PMI will allow just that.
Consumer education, coupled with rapidly declining test kit costs, are key to consumer genomic adoption. At this point, genetics knowledge among consumers and clinicians, is minimal.
People will eventually become more empowered to be responsible for their own health, with important genetic information helping prevent future disease.
Historically, obtaining genetic data was more expensive, consumers were asked to pay multiple hundreds of dollars. Now the cost is $99-plus. Part of Helix’s goal, for instance, is to make genetic insights even more bite-sized with the idea of $10 apps after someone has their data stored.
Outlook
The next few years could be game-changing for the consumer genomics industry.
We are seeing strategic alliances among major biopharmaceutical, genomic, lab and academic medical centers form that never would have been thought conceivable.
Once regulatory hurdles are overcome, test kit prices decline further, consumer success stories are publicized and precision medicine initiatives take shape, genetic testing could indeed change the way we manage healthcare.