FDA sends letter to the California-based start-up concerning clearance for SureDNA test kit before accepting pre-orders from consumers
Competition to market whole-human genome sequencing to consumers is heating up. Not only is the Food and Drug Administration (FDA) watching these developments, but it is taking action to regulate companies that offer direct-to-consumer whole-human genome sequencing in developments that should be watched by clinical laboratory managers and pathologists.
One example is Sure Genomics. It claims to be breaking barriers by offering a $2,500 at-home whole human genome test to consumers.
The company believed the new test kit, called SureDNA, would escape FDA restrictions on the direct sale of health reports to consumers. However, the FDA’s recent letter to the California-based startup indicates Sure Genomics may face the same regulatory roadblocks that have stymied other direct-to-consumer genetic testing companies.
SureDNA Test Provides a Plethora of Information
Sure Genomics launched SureDNA in early February. On February 9, 2016, it announced a $2,500 at-home kit to deliver a person’s full DNA sequence with a single saliva test. The service includes:
• Full DNA sequencing by a CLIA lab;
• HIPAA data storage;
• Ongoing reports;
• DNA reanalysis every six months; and
• A one-hour consultation with a trained genetics professional.
After the first year, the consumer can pay a $150 annual subscription fee to cover data storage and semi-annual DNA analysis against new and clinically validated markers.
Gene Sequence Data Comes with ‘Oversight’ by a Physician
The company states customers will receive initial reports “made available with physicians’ oversight” that will include:
• Drug response and interaction;
• Fitness and nutrition; and
• Traits and ancestry.
FDA Request Clearance Number for SureDNA Test
Sure Genomics made the SureDNA kit available for preorder on their website and expected to begin shipping kits to consumers by June 2016. However, one week after launching its service, Sure Genomics received a letter from the FDA addressed to the company’s CEO, Warren Little, and its co-founder Rick White. The letter stated that the FDA was unable to locate any clearance number for the SureDNA test. “We request that you provide us with the FDA clearance number for the SureDNA test. If you do not believe that you are required to obtain FDA clearance for the SureDNA test, please provide us with the basis of that determination,” the FDA’s letter stated.
Is Sure Genomics on Regulatory Thin Ice?
Sure Genomics says it uses a network of physicians to prescribe genetic testing and results are delivered “under physician supervision.” Therefore, the company maintains that it is acting in an “ultra-compliant manner.”
“We have been in contact with the FDA and we feel like we’ve built a system and process that would meet their requirements,” White told The Verge. “[Our] reports are going to be delivered in, I would say, an ultra-compliant manner.”
However, The Verge argues that Sure Genomics is “treading on thin ice” by delivering health risk assessments without getting FDA clearance first. The Verge noted the FDA’s initial response to a similar personal genome service, 23andMe, highlighted the agency’s fears that patients could be put at risk if they received incorrect test results or did not understand their results. (See Dark Daily, “23andMe Socked with FDA Warning Letter and Class Action Lawsuit over Company’s Genetic Testing Services,” December 11, 2013.)
“Since then, 23andMe has made some big changes and conducted studies that have helped it obtain FDA clearance for tests that tell people if they’re likely to pass down certain health conditions to their kids,” The Verge wrote. “But the government agency still hasn’t given approval for disease risk estimates that are sent directly to consumers. That’s why Sure Genomics’ assertions that its health risk and drug response reports will be just fine with the FDA are so puzzling.”
Mark Rothstein, JD, Director of the Institute for Bioethics, Health Policy and Law at the University of Louisville School of Medicine, told The Verge that he doesn’t believe Sure Genomics’ use of a prescribing physicians will alter the FDA’s view of the direct-to-consumer test.
“I don’t think getting a doctor to order the test changes anything,” Rothstein stated.
Less than 50% of At-Home Genetic Tests Users Share Results with Their Doctors
An article published on GenomeWeb also pointed out that in a January 2015 letter, Alberto Gutierrez, Director of the Office of In Vitro Diagnostics and Radiological Device Evaluation in the FDA’s Center for Devices and Radiological Health, noted that the agency was looking into direct-to-consumer testing services that rely on ordering of the test “either by the physician that is incorporated into the company or [who] somehow has a relationship not with the patient but with the company.”
In addition, a study published in the Annals of Internal Medicine titled, “Consumer Perceptions of Interactions With Primary Care Providers After Direct-to-Consumer Personal Genomic Testing,” questions the overall value of at-home genetic test kits.
The researchers surveyed 23andMe customers, as well as those of Pathway Genomics, which in January released Genomics OME, a “personalized wellness app” powered by IBM’s Watson. The researchers found that only 63% of users planned to share their DNA results with their primary care physician. And, six months after receiving results:
• Only 35% of those who used the tests had shared the information with a healthcare provider;
• Only 35% of the patients who spoke to their primary care doctors about their results were satisfied with the discussions; and
• Nearly one in five people reported being not at all satisfied.
Wylie Burke, MD, PhD, Professor in the Department of Bioethics and Humanities at the University of Washington, co-authored an editorial that accompanied the Annals of Internal Medicine study. In it, Burke compared direct-to-consumer genetics tests to prostate screening and whole body scans that “deliver uncertain information and create patient expectations that may align poorly with evidence, clinical priorities, or, in some cases, the patient’s best interests.”
FDA Expected to Issue Regulation of LDTs
The FDA’s hardline on direct-to-consumer marketing of genetic tests may foreshadow bigger news regarding the agency’s plans to regulate laboratory-developed tests (LDTs). The FDA is expected to issue rules for the regulation of LDTs later this year, a move that will have widespread impact on clinical laboratories and pathology groups.
—Andrea Downing Peck
FDA Letter to Sure Genomics, Inc.
23andMe Granted Authorization by FDA to Market First Direct-to-Consumer Genetic Test Under Regulatory Pathway for Novel Devices
23andMe Launches New Customer Experience–Reports Include Carrier Status that Meet FDA Standards, Wellness, Traits, and Ancestry
Sure Genomics Introduces First Full DNA Sequence to Consumers Delivered on an Interactive, Easy to Comprehend Platform
Sure Genomics Wants to Sell Private Genetic Profiles for $2,500 but it’s Really Testing the FDA
Consumer Perceptions of Interactions with Primary Care Providers After Direct-to-Consumer Personal Genomic Testing
23andMe Socked with FDA Warning Letter and Class Action Lawsuit over Company’s Genetic Testing Services