23andMeLogo_MagentaLime23andme received word from the Food & Drug Administration (FDA) on November 22, 2013, that they must cease and desist selling the company’s Saliva Collection Kit and Personal Genome Service (PGS).

FDA explained in their Warning Letter,

“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.

“Some of the uses for which PGS is intended are particularly concerning, such as assessments for BRCA-related genetic risk and drug responses (e.g., warfarin sensitivity, clopidogrel response, and 5-fluorouracil toxicity) because of the potential health consequences that could result from false positive or false negative assessments for high-risk indications such as these.

The Letter goes on to explain that after several communications with 23andme, the FDA is not assured that the company has sufficiently clinically validated the test. Therefore, the FDA asked the company to “discontinue marketing the PGS until such time as it receives FDA marketing authorization for the device.”

23andme offered this simple response today on the 23andme blog:

“We have received the warning letter from the Food and Drug Administration. We recognize that we have not met the FDA’s expectations regarding timeline and communication regarding our submission. Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns.”

In Matthew Herper’s exposition of this story on Forbes this afternoon, called 23andStupid, he wrote that,

The FDA’s account seems to show the agency giving 23andMe a lot of chances, and to show a willingness to find a way to work with the startup. The FDA references 14 face-to-face meetings and telephone calls, hundreds of emails and dozens of written communications during which the agency said it provided specific feedback on study protocols that would prove 23andMe’s tests were useful as diagnostics and other tests to prove the 23andMe kits gave consistent results. Instead, 23andMe expanded how its test was used. In January, the FDA says the company promised that it was doing extensive studies that would take months to complete – and then that promised data never materialized. This is not the way to deal with a powerful government regulator,

sub-titling his article with the question, “Is 23andme self-destructing?”

As of September 2013, there were over 400,000 paying customers for 23andme’s kits, according to a Business Week article titled, “23andme wants to take its DNA tests mass market.”

Anne Wojcicki, a co-founder of 23andme, recently told Fast Company magazine that the objective of the company has been to enroll 25 million people to get to a scale where data can be sliced and diced for medical research and personal health insights. “”Once you get 25 million people,” Wojcicki explained, “there’s just a huge power of what types of discoveries you can make.”

You can follow 23andme on Twitter at 23andme.

This story is already well-covered in business and mass media publications, including:

Bloomberg, FDA Tells Google-Backed 23andme to Halt DNA Test Service

NPR, FDA Tells 23andme to Stop Selling Popular Genetic Test

Reuters, FDA Warns Google-Backed 23andme to Halt Sales of Genetic Test

USA Today, FDA Halts Sales of 23andme Test Kits

Health Populi’s Hot Points:  I have a very personal view on this as a user of 23andme. I introduced my husband and daughter to the spit test, and we have all participated in this program.

Each of us has believed the test to be useful for different reasons:

For me: With a mother who died all-too-young from a seemingly random leukemia, I was keen to assess my ranges of risk for various cancers. Understanding that these are preliminary and certainly not the final word, I have found this information to be useful as far as it goes. The information has started a conversation between my doctor and me, the likes of which I would not have been able to have without this genetic snapshot. Furthermore, for a life like mine whose family records were largely lost in World War II’s diaspora of Eastern European people, the ancestry data has led me to find at least one “real” cousin in New York City about whom I hadn’t known, and several others with whom I am following up.

For my husband: Born from parents with two different backgrounds, my husband has gained insights into his multi-layered ancestry that has allowed him to connect many disparate dots on his family history. With both parents gone, he is able to continue to learn more about his genealogy and gain insights into various aspects of his life, some meaningful, others practical.

For our daughter: Adopted from Vietnam at 6 months of age, our daughter has known nothing, zero, nil, about her heredity, genetic makeup or ancestry. The only health information we obtained upon receiving her ‘matching’ information from the Vietnamese feeding center (orphanage) before adopting her was her height and weight at birth, and an HIV (negative) blood test and Hepatitis C blood test (negative) at four months of age. That was all the health data we had in hand before agreeing to adopt this baby, who has grown over the ensuing years to be, thanks be to those randomizing health gods, a healthy, resilient, and simply wonderful young woman.

But 23andme has opened a window into our daughter’s life and health that we would not otherwise have at this stage of her life. She now has some preliminary information that she, and we, can use – to plan, prevent, optimize, and empower.

Matthew Herper is right when he says that, “…none of (23andme’s) high-minded ideals release it from the requirement the FDA wants to enforce: that a medical device has to work.”

The FDA’s Warning Letter asserts that 23andme had not responded after numerous requests for additional information on clinical validation. We 400,000+ consumers who have a vested interest in the clinical validity of 23andme’s saliva test are keen to hear a full response from 23andme – to us, and especially, to the FDA.