FDA’s assertion of power to regulate genetic tests is a familiar argument to pathologists and clinical laboratory scientists, but does create problems for 23andMe

It has been national news since November 22, when the Food and Drug Administration (FDA) sent a letter to 23andMe ordering it to stop the sale of direct-to-consumer genetic tests. The FDA said that 23andMe had failed to prove the validity of its genetic tests and gave the company 15 days to respond and  identify the steps it would take to address  FDA concerns.

This event has fulfilled the predictions of many pathologists and clinical laboratory professionals. Having dealt with the FDA throughout their careers, experienced medical laboratory scientists knew that the FDA would eventually take enforcement action against 23andMe, if the company did not provide adequate scientific information to support the clinical validity of its genetic tests.

FDA Said 23andMe Must Take Its Genetic Tests Off the Market

The FDA’s warning letter to 23andMe was blunt and to the point. It ordered the company to immediately take its genetic tests off the market and cease advertising genetic testing.

In one paragraph of the letter, the FDA wrote: “This product is a device within the meaning of section 201(h) of the FD&C Act, 21 U.S.C. 321(h), because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to effect the structure or function of the body. For example, your company’s website at www.23andme.com/health (most recently viewed on November 6, 2013) markets the PGS for providing ‘health reports on 254 diseases and conditions,’ including categories such as ‘carrier status,’ ‘health risks,’ and ‘drug response,’ and specifically as a ‘first step in prevention’ that enables users to ‘take steps toward mitigating serious diseases,’ such as diabetes, coronary heart disease, and breast cancer. Most of the intended uses for PGS listed on your website, a list that has grown over time, are medical device uses under section 201(h) of the FD&C Act. Most of these uses have not been classified, and thus require premarket approval or de novo classification, as FDA has explained to you on numerous occasions.”

23andMe’s co-founder, Anne Wojcicki (pictured above) has found herself in the eye of a regulatory hurricane after her company received a warning letter on November 22 from the Food and Drug Administration. At issue is the direct-to-consumer genetic tests offered by 23andMe, which the FDA asserts fall under its jurisdiction to regulate. (Photo by 23andMe.)

23andMe’s co-founder, Anne Wojcicki (pictured above) has found herself in the eye of a regulatory hurricane after her company received a warning letter on November 22 from the Food and Drug Administration. At issue is the direct-to-consumer genetic tests offered by 23andMe, which the FDA asserts fall under its jurisdiction to regulate. (Photo by 23andMe.)

For its part, 23andMe was forced to acknowledge that it had not taken all the steps required by the FDA. CEO Anne Wojcicki, who was quoted on the company’s website, stated that the company had filed its first application for FDA clearance in 2012. The company has been marketing its genetic tests since 2007 and has been in communication with the FDA since 2008. She noted, “We received feedback on those [FDA] submissions and acknowledge that we are behind schedule with our responses.”

Similarly, on November 27, Wojcicki sent an email to its customers. In the email, she wrote: “I apologize for the limited response to the questions many of you have raised regarding the [FDA] letter and its implications for the [genetic testing] service. We don’t have the answers to all of those questions yet, but as we learn more we will update you.”

Internet Bloggers Debating FDA’s Letter to 23andMe

The Internet is abuzz with interesting speculations about why a company like 23andMe would allow itself to get on the wrong side of the FDA. In a news story published by Bio-IT World, the writer said: “John Wilbanks sees 23andMe’s long silent treatment toward the FDA as a reflection on the strength of their data. With hundreds of thousands of gene panels performed, 23andMe has gathered more information than anyone on how genetic variants relate to human health. If they have refused to engage with the FDA, he posits, their tests are either so well validated that the company expects to emerge victorious from a confrontation, or so poorly validated they can’t afford to expose their data to the public eye.”

Bio-IT World went on to quote another blogger. “This sounds as though 23andMe started down the FDA path but, six months ago, not only stopped communicating with the agency, but started new and bigger marketing efforts. That sounds as though 23andMe did not just ignore the FDA, but while walking briskly past it, quickly turned and spat in its face,” said Hank Greely in a blog for Stanford’s Center for the Law and the Biosciences.”

For its part, 23andMe did cease its marketing campaign for its $99 Saliva Collection Kit and Personal Genome Service (PGS), which involved advertisements on television, radio and the Internet. That took effect last week, according to a 23andMe spokesperson.

Class Action Lawsuit Filed in California against 23andMe

But 23andMe’s troubles are not limited to the FDA. Last week, a class action suit was filed in California  by Lisa Casey, who alleges that the genetic test results are “meaningless,” among other charges. The plaintiff is seeking $5 million and estimates that the class of U.S. customers may number in the “tens or hundreds of thousands.”

There is another interesting twist in this case. In a news story about the lawsuit, Matthew Perrone of the Associated Press wrote: “Elsewhere, the complaint notes that 23andMe compiles customers’ genetic information, which it then markets to scientists for research.” 23andMe has acknowledged that it hopes to pool the information from millions of customers to eventually create databases that can be mined for medical research.

“It seems to me to be a very thinly disguised way of getting people to pay them to build a DNA database,” said Mark Ankcorn, a San Diego attorney who filed the lawsuit on behalf of Casey. Ankcorn said he was contacted Monday by an attorney representing 23andMe. “I anticipate they are going to fight it and use every available resource they have to deny the claims,’ he said.”

Ankcorn’s statement about 23andMe’s goal of building a DNA database incorporating information from one million individuals offers an intriguing insight into the company’s downstream strategy to leverage that genetic information in ways that go beyond simply selling researchers access to the genetic database. 23andMe could also negotiate agreements that allow it to participate in the profits that result from any proprietary or patented products that might be developed as a result of information teased out of the genetic database.

Is the DNA Database More Valuable Than  the Genetic Tests?

If true, that would mean that 23andMe’s genetic testing activities are simply a front door approach to assembling a much more valuable DNA database made up of information from 1 million individuals. Pathologists and clinical laboratory managers should take note of this aspect of 23andMe’s business strategy. Going forward, clinical laboratories may have similar opportunities to acquire patient specimens—with informed consent—and assemble their own databases of valuable genetic information.

Related Information:

FDA Warning Letter to 23andMe, November 22, 2014

23andMe CEO Responds to FDA Warning Letter; Anne Wojcicki Defends Genetic Tests, Acknowledges Company Late in Responding to Agency Concerns

23andMe Statement Regarding FDA Warning Letter

FDA Warning to 23andMe Spawns Class-Action Complaint

23andMe faces class action lawsuit in California

An Update Regarding The FDA’s Letter to 23andMe

23andMe: State of the Debate

23andme Gets A Nastygram For The Holidays

Why the FDA’s anvil dropped on 23andMe