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FDA Slaps Personal Genomics Startup 23andMe With Stiff Warning

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Earlier today, the FDA released a letter it sent last Friday to personal genomics startup 23andMe (here). The warning letter served notice to the company  and the broader digital health startup community  that the power of the FDA is not something to be taken lightly.

Failure to take adequate corrective action may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties. James L. Woods  Deputy Director, Patient Safety and Product Quality, Food and Drug Administration

It's a strongly worded warning against the high-profile personal genomics startup. Founded in 2006, the company has raised over $160 million through some leading Venture Capitalists including New Enterprise Associates, Mohr Davidow, Google Ventures  and Google Co-Founder himself  Sergey Brin. According to Crunchbase (here), 23andMe is one of only two startups that Brin has personally invested in (the other being Tesla Motors ).

The logic can be persuasive. According to the website, for $99 I can get:

* reports on 240+ health conditions and traits

* Discover your lineage, find relatives and more

* Get updates on your DNA as science advances

Life changing testimonials are featured on the landing page and there's even the appearance of Federal Government endorsement with the use of the Centers for Medicare & Medicaid (CMS) logo (How it Works page here).

There is also a broad disclaimer on the bottom of the page that lists the 240 diseases and conditions (here).

According to this Bloomberg article (here), in July of last year, the company submitted a request to the FDA to "cover seven tests." Today's letter from the FDA suggests that there were additional submissions later last year, but the combined total is still likely to be a small fraction of the 240+ diseases and conditions referenced on the website for $99.

More importantly, the actionable value of any clinical insight without FDA approval remains questionable. Even with FDA approval, key scientists are highly skeptical of their individual value.

They [23andMe] analyze a million genes out of three billion total and the impact those million play in long term-health outcomes is still in dispute. For example, the nature/nurture split is normally viewed at 30/70 — meaning environmental factors play a far more significant role in long-term health outcomes than genetics. As Stanford University's Nobel Prize-winning RNA researcher Andy Fire once told me, “if someone off the street is looking for pointers on how to live a healthier life, there’s nothing these tests will tell you besides basic physician advice like ‘eat right, don’t smoke and get plenty of exercise.'” Steven Kotler  Forbes Contributor (December, 2012 here)

Low pricing aside, the physical steps in the process seem relatively easy. The "spit kits" themselves are manufactured by OraSure Technologies, Inc. with a unique barcode and then sent directly to consumers who have paid the $99. The kits are then shipped (presumably by the consumer) directly to Laboratory Corporation of America (LabCorp) for processing. LabCorp, in turn, is contracted to use the Illumina HumanOmniExpress-24 format chip for actual genotyping. These results are then electronically transmitted back to 23andMe where (based on the barcode) they are then matched to the consumer account created during the sign-up process.

As the FDA pointed out in the letter, the risk that these tests can produce either a false positive or a false negative is the primary concern of the FDA and its approval process.

For instance, if the BRCA-related risk assessment for breast or ovarian cancer reports a false positive, it could lead a patient to undergo prophylactic surgery, chemoprevention, intensive screening, or other morbidity-inducing actions, while a false negative could result in a failure to recognize an actual risk that may exist. Assessments for drug responses carry the risks that patients relying on such tests may begin to self-manage their treatments through dose changes or even abandon certain therapies depending on the outcome of the assessment. For example, false genotype results for your warfarin drug response test could have significant unreasonable risk of illness, injury, or death to the patient due to thrombosis or bleeding events that occur from treatment with a drug at a dose that does not provide the appropriately calibrated anticoagulant effect.

The original request for FDA approval is relatively easy and painless. At the time of the filing, 23andMe's Chief Legal Officer was quoted as saying:

The result that you get when you review a [23andMe] report, the FDA wants to ensure that’s a valid result. Ashley Gould  Chief Legal Officer at 23andMe (July 2012  quoted here)

Ms. Gould has since left 23andMe, and as of last Friday, the FDA has officially notified the company that clearly no such marketing approval is pending. The company issued this statement earlier today:

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.