Genetic Testing can Revolutionize Health Care…FDA Permitting

January 22, 2019

As weight watching meets personal genetics, health-conscious consumers are increasingly ditching old-school overly broad (and often misleading) nutrition guidelines in favor of the individualized cheek swab. Earlier this month, consumer genetic testing provider 23andMe announced a partnership with Lark Health, which offers an artificial intelligence (AI) “coach” to help users lose weight based on their specific genome. Now, 23andMe consumers will be able to input their personal genomic information into Lark Health’s app, giving them genetic guidance over whether or not to eat that steak sandwich for lunch.

Using the latest data and technology, this integration gives consumers unprecedented insight into their personal health rather than relying on broad, confusing guidelines dreamed up by the US Department of Agriculture (USDA). Unfortunately, retail genetic testing has been repeatedly stymied by onerous Food and Drug Administration (FDA) regulations, ensuring fewer collaborations like the Lark Health partnership. By embracing innovation and allowing consumers to have access to their own DNA for personal health services, the agency can pave the way for a revolution in personal health-care.

Since their launch in 2006, 23andMe has touted an ever-expanding volume of health information available to help consumers. But in 2013, the FDA barred 23andMe from sharing health-related predictions tailored to customers’ genetic markers. For example, my own 23andMe report gave me risk percentages of developing major diseases relative to the population, allowing me to alter my lifestyle accordingly. But following the FDA crackdown, all of that critical information was suddenly stripped from me. In justifying the ban, the administration reasoned that any disease probability estimate was inherently misleading since the vast majority of genes playing a role in the development of the illnesses are not known. In the government’s view, 23andMe was assigning an unreasonably-high weight to a handful of genetic markers they had analyzed.

The administration slightly backtracked in 2015, when they allowed the testing company to alert their customers to the presence of “carrier genes” in user DNA. Genetic markers associated with cystic fibrosis and sickle cell anemia strongly predict the diseases in carriers’ children and are thus particularly useful in pre-identifying health threats. The latest liberalization, announced in April of 2017, allowed 23andMe to identify a handful of diseases and/or conditions that may afflict the actual customer, as opposed to his/her progeny. The list of approved diseases, which includes late-onset Alzheimer’s Disease and Parkinson’s Disease, was approved by the FDA only after agency certification that identified markers were in fact strongly correlated with the diseases.

While the agency’s loosening of rules is a step in the right direction, the prevailing process is still far too strict and prevents consumers from taking actions to improve their health. In March 2018, 23andMe was only able to obtain limited approval for notifying consumers that their DNA contains BRCA gene mutations, which indicate a significantly increased risk of cancer. While the FDA gave the go-ahead for the test, it required the company to include a slew of labeling that downplays the significance of test results, preventing consumers from being accurately aware of the risks they face and thereby altering their lifestyles as a result. Furthermore, despite this mild liberalization, the majority of tests still remain unavailable to consumers.

To make matters worse, contrary to the pronouncements of agency officials, slow-tracking genetic testing products don’t save consumers from acting on misleading or incomplete information. If 23andMe shares subscribers’ DNA sequences with them, but withholds any educated guesses about disease profiles, customers are unlikely to simply “rollover” and confine themselves to uncertainty. Rather, they’re likely to sleuth genetics discussion forums and pseudoscientific web pages for more information. The current system, therefore, represents the worst of all worlds where consumers are unable to get accurate information but have easy access to potentially misleading and damaging information that has arisen in its place.

It’s not surprising that Google Trends for search terms like “DNA results” and “genetic markers” show small but noticeable growth starting in 2013 after remaining flat or declining for the previous two years. Among the beneficiaries of this internet traffic has been a low-budget web service called Promethease, where users can input their raw genetic data inputted via 23andMe and obtain a comprehensive medical literature review on their genetic markers. Search traffic around this website, which nearly tripled in the three months after the FDA’s initial clampdown on 23andMe, demonstrates a consumer willingness to work around cumbersome rules imposed by bureaucrats.

Rather than forcing consumers to sleuth around the web to find out what their DNA says about them, the FDA should allow for more “above-ground” innovation similar to the partnership with Lark Health. Empowering consumers will improve health outcomes and save lives while driving healthcare costs down. Market innovation can pave the way for more interactive weight-loss apps, and fewer outdated food pyramids.