FDA decision allows 23andMe back in genetic testing business (but it means so much more)

23andMe can offer genetic-testing services again after the U.S. Food and Drug Administration said the California company can sell a kit to test for Bloom Syndrome, an obscure affliction that occurs when the altered gene is carried by both patents. This is a crack-in-the-dam moment – not just for 23andMe, which has been out of […]

23andMe can offer genetic-testing services again after the U.S. Food and Drug Administration said the California company can sell a kit to test for Bloom Syndrome, an obscure affliction that occurs when the altered gene is carried by both patents.

This is a crack-in-the-dam moment – not just for 23andMe, which has been out of the genetic testing business for months – but for the consumer-driven, patient-empowered world of new healthcare.

The announcement by the FDA about 23andMe included a statement, attributed to Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health, which essentially said consumers don’t need doctors to dive into their own genetic makeup.

“The FDA believes that in many circumstances it is not necessary for consumers to go through a licensed practitioner to have direct access to their personal genetic information. Today’s authorization and accompanying classification, along with FDA’s intent to exempt these devices from FDA premarket review, supports innovation and will ultimately benefit consumers.”

The FDA stated genetic testing kits like those offered by 23andMe will be classified as Class II diagnostics and thus don’t have to receive a government OK before marketing their products. The FDA now opens this ruling to public comment for the next 30 days.

Expect a ferocious discussion. Those advocating direct access to genetic information are pitted against others who think patients still need a guide to understand and put this data into context before receiving it.

But just getting to that statement by the FDA is a major moment.

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23andMe had been yanked out of the genetic testing business by the FDA back in November 2013, when the agency said 23andMe had stopped communicating with the government and hadn’t done enough testing to prove its tests were good enough to identify issues like a predisposition for breast cancer. At the time, the agency said 23andMe needed premarketing approval – the opposite of what it is saying now.

Months before it was blocked from offering genetic testing, the company had closed a $50 million fund-raising round, dropped the price of its kits to a more-affordable $99, and launched an aggressive and slick marketing campaign.

23andMe forced the FDA’s hand and paid for it. After November 2014, it could only market itself in the United States for ancestry research (late last year it launched genetic testing in the Britain).

On Thursday, the FDA said 23andMe completed a pair of studies that showed the kits were good enough to test for Bloom Syndrome. In an interview with the Associated Press, company CEO Anne Wojcicki said the company has another 45 to 50 tests it would like to bring back to the market using the same approach.

In its own release, 23andMe stated: “This is the first step in our commitment to returning health information to our customers.  We will continue to keep our community involved in our progress, but will not return results on individually cleared reports until we complete the regulatory process on additional health reports and have a more comprehensive product offering.”

It’s not as if the FDA didn’t hedge its bet, however. In its announcement, the agency stated “no test is perfect” and noted “when a gene mutation is expected to be very rare, a positive result for the mutation may have a high probability of being wrong.”

Plus, the FDA will require 23andMe to provide information on “how to obtain access to a board-certified clinical molecular geneticist or equivalent to assist in pre- and post-test counseling,” among other details.

“While the FDA is not limiting who should or should not use these tests, it is requiring that the company explain to the consumer in the product labeling what the results might mean for prospective parents interested in seeing if they carry a genetic disorder,” the FDA’s announcement stated.

Now comes the bigger discussion. The FDA’s announcement provides a road map in which 23andMe and other testing companies can bring their products to the market. It will also give way to some of the bigger debates.

Will patients suddenly demand unnecessary medical treatments or opt for invasive and overreaching procedures because of the information it gets from testing kits? Will that spike costs in healthcare?

On the other hand, why should the medical community be a gatekeeper for such empowering and easily accessible health information about a person’s intimate medical history? It’s the modern-day equivalent of blocking someone from checking if they have a temperature.

David Kroll framed it perfectly on Forbes.

Companies like 23andMe have also been criticized for overinterpreting the impact of genetic variations, most of which are statistical associations, not necessarily clear cause-and-effect. For example, a preference for the herb, cilantro, was listed in my 23andMe profile as associated with a 10% chance of liking or disliking it. Making a promise based on such a small change is almost meaningless (and my result was exactly the opposite of the one expected with my love of cilantro).

But the truth of the matter is that consumer demand for one’s genetic information is only increasing and we will soon be walking around with our entire DNA sequence on a flash drive or a chip in our health insurance card.

What an odyssey for this industry and for 23andMe (see Wojcicki below at the Cleveland Clinic Innovation summit in 2009).

Thursday was a turning point.

[Photo from Flickr user Rachel Knickmeyer]