Helix Launches Online Personal Genomics Testing Marketplace
A work-around for the FDA's ban on direct-to-consumer genetic testing?
Helix wants you to become a lifelong repeat customer in its newly launched genomics testing marketplace. For $80 the company will use your saliva sample to sequence all 22,000 protein-coding genes in your exome, along with some additional genetic sequences that its scientists find relevant to human health. The exome (the protein-coding region of the human genome) represents less than 2 percent of the genome but contains about 85 percent of known disease-related genetic variants. The company says it will keep your genetic information securely on file.
Customers can now purchase various genetic testing "apps" from about a dozen vendors in Helix's genomics marketplace. Helix will share the relevant sections of your exome with the vendors, who then provide the results of their readouts directly to you.
The current options include an ancestry testing app from National Geographic ($69.95); a family planning test from Sema4 ($199) that tells you if you are a carrier of any of 67 different genetic variants that might affect the health of your prospective children; a fitness app from Exploragen ($24.99) that identifies genes that may affect your sleep pattern; a health app from Admera ($124.99) that tests for a genetic predisposition to having high levels of bad cholesterol; and a nutritional app from Everlywell ($249) that tests for food senstivities that may be related to your genetic makeup. There is even a wine explorer entertainment app by Vinome ($29.99), which claims to match your genes to your vintage tastes.
Now that Helix has created a genomics marketplace, the company plans to add new validated tests from additional app vendors over time. Once they become available, Helix customers can purchase them and then simply have their online genetic information sent along for analysis. Prior to getting the results from the health apps in the marketplace, customer's health histories are evaluated by physicians from an independent third party network.
That part—the evaluation of health app results by independent physicians—is clearly aimed at getting around the Food and Drug Administration's outrageous ban on direct-to-consumer genetic testing. The ban essentially began in 2013, when the agency shut down the personal genomics start-up 23andMe. In April of this year, the agency finally relented somewhat and allowed 23andMe to offer tests to identify genetic variants that contribute to 10 different conditions, including Parkinson's disease, late-onset Alzheimer's disease, and a blood-clotting disorder. But tight restrictions are still in place. When I was an early customer, the company provided me with genetic insights not just about those 10 health risks, but also about 140 others.
We will never know how much further along companies, customers, and medical practitioners would be now had the government not hamfistedly stymied the development of direct-to-consumer genetic testing for four years. The good news is that the Helix marketplace model seems designed to work around such regulatory excesses and enable Americans to gain access to their genetic information.