23andMe hit with class action suit

After FDA warning letter, woman accuses company of 'misleading' practices

The local biotech firm, 23andMe, which captured the spotlight for selling DNA sequencing kits directly to consumers, was hit with a class action lawsuit less than a week after the Food and Drug Administration demanded it cease marketing of its flagship product.

First came the letter from the FDA. Signed Nov. 22 by Alberto Gutierrez, director of the Office of Invitro Diagnostics and Radiological Health at the Center for Devices and Radiological Health, the letter warned the company that it was marketing its "Saliva Collection Kit and Personal Genome Service (PGS) without clearance or approval in violation of the Federal Food, Drug and Cosmetic Act."

"Specifically, the FDA is concerned with the unsubstantiated medical claims being made by 23andMe," FDA spokeswoman Susan Laine said in an email. "Results from this test may lead consumers to make major medical decisions that may be irreversible without input from a qualified health care professional."

Then came the lawsuit. Filed on Nov. 27 by Lisa Casey in the U.S. District Court, Southern District of California, the suit cites "unfair business practice" and "false and misleading advertising."

Representatives from the Mountain View-based 23andMe aren't saying much. They declined to comment on the class action suit.

Following reports that the company continued to market and sell its Personal Genome Service product after receiving the FDA's letter, two separate spokeswomen for the company would only say that 23andMe has stopped marketing its product after receiving a warning letter from the Food and Drug Administration.

"23andMe halted all marketing last week in accordance with the FDA's instructions," said Tracy Gale of the public relations firm WCG in an email to the Voice, echoing another spokeswoman's response. Neither mentioned anything about the company continuing to sell its products.

After that, both women referred the Voice to a brief statement on the company's website: "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."

That statement came in response to Gutierrez's letter, in which he indicated that he remained skeptical of the company's service. While the Personal Genome Service is marketed as a tool to empower consumers -- by informing them of certain genetic risks and providing them with knowledge that would help them make better treatment choices -- Gutierrez wrote, "we still do not have any assurance that the firm has analytically or clinically validated the PGS for its intended uses. ... Therefore, 23andMe must immediately discontinue marketing the PGS until such time as it receives FDA marketing authorization for the device."

FDA spokeswoman Laine noted that the administration has been in contact with 23andMe since July of 2009, and has repeatedly expressed concerns about the company's products. "However, after numerous interactions with 23andMe, including as recently as January 2013, the FDA still does not have any assurance that the company has analytically or clinically validated the test for its intended uses," Laine wrote.


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Posted by mari posa
a resident of Cuesta Park
on Dec 5, 2013 at 2:42 pm

Yeah! 23&Me knew very well that was operating under the table, performing and releasing results with methodologies which were not validated or approved by the FDA, and possibly erroneous and medically misleading. All professional companies know very well the rules of the industry and this company totally and bluntly operated illegally and unprofessionally with full knowledge of the rules.
I am glad to hear that there is a class action suit ongoing; 23&me needs to take responsibility for its actions and compensate accordingly all the past users.

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Posted by SP Phil
a resident of Shoreline West
on Dec 5, 2013 at 3:40 pm

For people who understand probabilities, the information from 23andme is not misleading.

My extended family, including two MDs, has purchased four kits over the years, with the understanding that the health-related information provided is based on very early research studies and only aims to indicate relative probability of being affected by a particular condition. In addition, I have a cousin who is a geneticist and has written popular books on the subject of genes and evolution--he got a 23andme kit.

Anyone who thinks that 23andme results are a substitute for medical exams and testing and and who thinks that any findings based on genetics are 100% accurate probably should not be "allowed" to buy a kit in the first place.

The rest of us find the information interesting and look forward to further research in the field.

SP Phil (who also was an early participant in the National Geographic Genome Project)

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Posted by mari posa
a resident of Cuesta Park
on Dec 5, 2013 at 4:25 pm

There is a difference in finding the information interesting and being accurate. As scientist, I know very well by experience that it is extremely dangerous to release medical information based in tests that are not validated. Simply, it is not acceptable and they have high probability of rendering misleading or inaccurate results.

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Posted by Grrrreat!
a resident of Cuesta Park
on Dec 6, 2013 at 2:18 pm

This is awesome. Take that 23&Me. Now we just need to be rid of google. YES! I'm dancing in my apartment right now. I LOVE the FDA!

Like this comment
Posted by PeaceLove
a resident of Shoreline West
on Dec 6, 2013 at 5:00 pm

Tough call. I'm a proponent of having more information. I got a 23&Me kit and was pleased with the information it provided. I would never make medical decisions on the basis of their tests without getting follow-ups from actually doctors. Anyone who would is a fool.

Is the issue in how they market themselves? Don't they state that up front the testing is for informational purposes only and should not be taken as a substitute for genuine medical testing? Or is the problem that their tests are not actually trustworthy (which would surprise me, given the founders)?

The great scientific and medical benefit of a company like 23&Me is that it facilitates the rapid collection of a vast amount of data on a lot of people--IF their results are accurate and dependable.

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Posted by biorider
a resident of Cuesta Park
on Dec 6, 2013 at 5:50 pm

You think the class action lawsuit was already filled out and waiting 'Lisa Casey' to click the send button? Just like most of biotech now, let the lawyers and trolls begin the feeding frenzy.

And no, not enough repeats in the Illumina test to make valid data.

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Posted by SP Phil
a resident of Shoreline West
on Dec 9, 2013 at 5:03 pm

Mari posa wrote: "it is extremely dangerous to release medical information based in tests that are not validated."

What are some examples of this "extreme danger"? A friend and I were discussing this and could only think of, for example, some people killing themselves because they thought they were at high risk of some dread condition. Are there other examples? Since provision of medical treatment is still strictly controlled by doctors and hospital gatekeepers, what is the concern? (I really want to know.)

Part of my sang froid about the 23andme results is that (1) MDs are often quite vague about their own diagnoses based on accepted medical tests. ("It may be cancer, but maybe not," for example.) And (2) I take the 23andme comments with even less conviction.

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Posted by forthepeeps
a resident of Rex Manor
on Dec 10, 2013 at 11:00 pm

SP Phil, please do not waste time arguing with mariposa, there's clearly no data to justify -- only prejudice, possibly jealousy.. Read "Grrrreat!'s" comments, seems like he's a Microsoft or Apple employee, but then I heard even those companies hire smart people.... Hmmmm.

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Posted by SP Phil
a resident of Shoreline West
on Dec 11, 2013 at 3:48 pm

For those wondering what the issues are/may be, here is a video entitled "23andme vs FDA in less than four minutes" Web Link

I am not involved with 23andme (except I have a kit) nor with the video. I do have a background in statistics and I do consult a physician re medical issues. I found the above video very interesting and clear as far as the issues involved.

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Posted by JacquelineS
a resident of Rengstorff Park
on Dec 12, 2013 at 1:48 pm

There are always at least two camps.... people who want to know, people who don't, then there are the curious. But after living enough life to get second opinions and maybe third opinions.... more information gives ME a place to focus. What about when depression is diagnosed for a woman? It happens all the time instead of a medical cause being found. Pregnancy tests can be wrong. So can a bunch of others.
People are complicated. Learn more, be smart.

Stop being whiny babies, and take some responsibility for your own health.

Like this comment
Posted by maguro_01
a resident of Castro City
on Dec 13, 2013 at 12:21 pm

(I now live on Franklin St in downtown Mountain View - what neighborhood is that?)

The FDA letter as published did reasonably demand more compliance with the regulations than 23andme has apparently taken.

But the letter went much further. It said that people should not have direct access to their personal genetic information at all. The grounds could deny people access to common fever thermometers or glucose meters purchased outright. It could also deny people access to drug data bases and almost any other medical information.

Long Term Care insurance providers have complained that if people have access to genetic information they don't (eg, Alzheimer's susceptibility), it breaks their business model. That will be true for medical insurance in general, especially pre-ACA. Opposition to 23andme can buy or sell Washington most of the time. Slipping in opposition to consumers ever knowing genetic information is suspect and protesting isn't irrational or cranky based on the record.

Medical care is supposed to become increasingly individualized based on one's genome. Cutting people out of that completely will eventually leave us completely ignorant and helpless in many ways. Perfect consumers, really..
From another BB - On December 01, 2013, at 8:50 AM, DickHamilton wrote:
Health insurance which is fully personalized isn't insurance at all - there is no sharing of risk, which is the only thing that makes health insurance (or fire insurance, or life insurance, or...) affordable. You deserve to have your own genetic information, and insurance companies should have access to aggregated genetic information so that they can better assess risk - but they should NOT have access to individual records - that would break the whole idea of 'insurance'.
Single Payer insurance and a mixed, mostly independent, medical care system like we have now but more efficient may be the only way to go given genetic-based medical care at all. Insurance companies and some medical people will lobby and fight bitterly to forbid consumers from having the information that they will need. Consumers must fight back. The special interests will tend to use moral arguments, this being California. Nonsense. As usual, follow the money.......

Like this comment
Posted by maguro_01
a resident of Castro City
on Dec 13, 2013 at 1:37 pm

ps - While the class action suit may be just another vulture suit entrepreneurial venture, it would still be interesting to check the plaintiff or the law firm for insurance company ties.

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