Published On: Wed, Nov 27th, 2013

Anne Wojcicki’s Start-up 23AndMe In Dispute With US Food And Drug Administration (FDA)

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Anne Wojcicki / Getty

Anne Wojcicki , age 30, is a biologist and a bio tech analyst. She is also a co-founder of the bio analytics start-up company 23andMe, based in Mountain View, California. 23andMe has so far reportedly raised over US$160 million in venture capital money, from Google Ventures and from a whole string of the best names in venture investing such as New Enterprise Associates, MPM Capital, Yuri Milner’s DST and the Roche Venture Fund.

Founded seven years ago, today the company presently markets online a personal genome service that tests for more than 240 “health conditions and genetic traits” at a cost of just US$99 for the service. The name “23andMe” elegantly references the 23 pairs of chromosomes into which human DNA is organized.

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Last week however 23andMe incurred the not nearly so elegant wrath of the US Food and Drug Administration (FDA) which sent the company a warning letter, basically calling for it to immediately cease and desist marketing its products, specifically 23andMe’s Saliva Collection Kit and Personal Genome Service (PGS), which the FDA stated it was doing without marketing clearance or approval in violation of the Federal Food, Drug and Cosmetic Act.

This letter apparently reflects serious concerns within the FDA whether the company’s products actually do what they purport to do, and is authored by the Director of its Office of In-vitro Diagnostics, Alberto Gutierrez.

Amongst its many concerns stated in the warning letter, the FDA specifically points out that:

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. 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.”

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The bottom line being that the PGS as an unapproved test, could be misleading users of it, and potentially seriously so, including possibly even suggesting unnecessary prophylactic surgeries. When movie star Angelina Jolie had prophylactic surgery for example, which received wide publicity at the time, it was after similar such genetic screening, though quite possibly by another company – and hopefully one in compliance with the FDA’s requirements.

Finally the FDA letter continues by complaining that,

to date 23andMe has failed to provide adequate information to support a determination that the PGS is substantially equivalent to a legally marketed predicate for any of the uses for which you are marketing it; no other submission for the PGS device that you are marketing has been provided under section 510(k) of the Act, 21 U.S.C. § 360(k).”

Again strong language, compounded by the FDA also stating it had not heard at all from 23andMe since last May, and that it was now therefore ordering them to discontinue marketing their products immediately and to provide a formal response outlining how to address all issues still outstanding, within fifteen business days.

You might think that 23andMe would rush to comply, but not a bit of it. Instead the company released a press release simply acknowledging receipt of the letter as follows:

“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.”

Otherwise the company’s web site seems to be continuing to function normally and to offer its services to potential customers online.

I don’t think that was quite what the FDA had in mind when they sent the letter, so it will now be interesting to see what transpires. If the company’s service is truly a valid one, then presumably a bit of regulatory TLC would certainly be in order now to stay on top of things.

About Anne Wojcicki

Anne Wojcicki, who is 30 years of age, was bon in San Mateo County, California to a Jewish mother, Esther Wojcicki née Hochman, who is a teacher and to a Polish American father Stanley Wojcicki a physics professor at Stanford University.

She graduated from Yale with a degree in biology in 1996 and joined the venture world as an analyst for ten years, focusing primarily on biotech investments.

In 2006 Ms. Wijcicki went out on her own to found 23AndMe with two business partners, Linda Avey and Paul Cusenza.

A year later, in 2007 she married Sergey Brin, a co-founder of Google, and they have two children together. News reports indicate that for the last three months they have been living separately but are not legally separated.

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