Anne Wojcicki Founder of 23andMe in Battle With FDA

Anne Wojcicki—founder of 23andMeAnne Wojcicki, Founder of 23andMe, in Battle With FDA

by Jeffrey Dach MD

Anne Wojcicki, founder of the online genetic testing service 23andMe. is now in a tooth and nail battle with the FDA.

It was announced that the company received a warning letter from the FDA demanding they cease marketing their home genetic testing kit, offered online for 99 dollars.   So far, the company has ignored the wanting letter and has continued with business as usual.

Why is the FDA targeting 23andMe ?

According to Christina Farr of Venturebeat,   the FDA is concerned that some people are demanding MRI’s and mastectomies after learning they have the BRCA gene for Breast Cancer.  The BRCA gene was originally patented by Myriad genetics, who lost the patent court-room challenge, so the test is now available to the public.  Angeline Jolie made news when she underwent double mastectomy after learning she carried the BRCA gene.

Interpretation of Genetic Testing Requires Professional Expertise

The Interpretation of genetic tests may not be so simple.  I would not recommend undergoing treatment with surgery on the basis of a $99 dollar genetic test without first consulting a health care professional with expertise in genetic testing.

23andMeLogoThe Genetic Tests Have Been Validated

According to the 23andMe website, “The genotyping services of 23andMe are performed in LabCorp’s CLIA-certified laboratory. The tests have not been cleared or approved by the FDA but have been analytically validated according to CLIA standards.”

Here is a partial list of the 23andME test panel:

Alpha-1 Antitrypsin Deficiency *
BRCA Cancer Mutations (Selected) *
Bloom’s Syndrome *
Canavan Disease *
Connexin 26-Related Sensorineural Hearing Loss *
Cystic Fibrosis *
Factor XI Deficiency *
Familial Dysautonomia *
Familial Hypercholesterolemia Type B *
Familial Mediterranean Fever *
Fanconi Anemia (FANCC-related) *
G6PD Deficiency *
Gaucher Disease *
Glycogen Storage Disease Type 1a *
Hemochromatosis *
Limb-girdle Muscular Dystrophy *
Maple Syrup Urine Disease Type 1B *
Mucolipidosis IV *
Niemann-Pick Disease Type A *
Phenylketonuria *
Rhizomelic Chondrodysplasia Punctata Type 1 (RCDP1) *
Sickle Cell Anemia & Malaria Resistance *
Tay-Sachs Disease *
Torsion Dystonia *

Will the public continue to have access to their genetic data, and will 23andMe  Stay in Business ?

The 99 dollar kit makes genetic testing available to the public at large. Should the public have access to their genome?  Should 23andME as a company have access to the enlarging database of millions of tests, and sell this database to the highest bidder? These are difficult questions that have ethical, moral and economic ramifications all brought out by the advent of high tech genetic testing.

fda-swat-teamsWill the FDA send a SWAT team to close down the 23and ME office and confiscate all the computers and records?   This is a distinct possibility.

This is a landmark battle and we will watch closely the final outcome.

For more, read my previous article on Understanding Online Genetic Testing.

Update Dec 2, 2013: 23andMe announces they have suspended marketing of their genetic testing service in response to the FDA warning letter.  They have also cancelled their online affiliate program which pays a link-thru sales commission to web sites that advertise their services.

Update 4/21/15 :  BACK IN BUSINESS !!!

23 and me are back in business offering testing for “ancestry information and Uninterpreted raw data”  for $99 with a home salivary kit.

23 and Me “December 6 2013: Pending an FDA decision, 23andMe no longer offers new customers access to health reports. Customers who received their health information prior to November 22, 2013 will still be able to see their health reports, but those who purchased after that time will only receive their ancestry information as well as access to their uninterpreted raw data. These new customers may receive health reports in the future dependent on FDA marketing authorization.”  quote from their web site.

Gene Variance Report :  “For a one time fee of $19.95 Livewello translates your genetic raw data from companies like 23andMe, AncestryDNA, Family Tree DNA and almost any other personal genomic service in the world. It will generate a Gene Variance report which contains information on thousands of disease related genes.”

“LiveWello’s Genetic tools will give you reports for 600,000 SNPs, AND attach 12 resources for learning about each gene. As long as a SNP has an rsID and Minor Allele, LiveWello will generate a gene report for you. The reason for this feature is that people should really have all the information about ALL the genes in their raw data not just some of them. That way, you and your Health Practitioner can have the benefit of all this information when creating your treatment plan.” quote from their web site

Jeffrey Dach MD

Links and References

http://upstart.bizjournals.com/news/technology/2013/11/26/anne-wojcickis-23andme-ignores-fda.html?page=2
November 26, 2013, 11:18am EST
Anne Wojcicki’s 23andMe ignores FDA request to stop marketing genetic testing (Video)

http://www.fastcompany.com/3022208/fda-tells-23andme-founder-anne-wojcicki-to-stop-marketing-99-genetic-test-or-face-penalties
FDA To 23andMe Founder Anne Wojcicki: Stop Marketing $99 DNA Test Or Face Penalties
By Tyler Gray

http://seattletimes.com/html/businesstechnology/2022330180_apxgenetictestsfdaaction.html
FDA tells 23andMe to halt sales of genetic test
The Food and Drug Administration has ordered Google-backed genetic test maker 23andMe to halt sales of its personalized DNA test kits, saying the company has failed to show that the technology is supported by science.  By MATTHEW PERRONE  AP Health Writer

http://upstart.bizjournals.com/news/technology/2013/11/26/anne-wojcickis-23andme-ignores-fda.html
November 26, 2013, 11:18am EST
Anne Wojcicki’s 23andMe ignores FDA request to stop marketing genetic testing (Video)

https://www.23andme.com/about/board/
Anne Wojcicki, Co-Founder
Anne brings to 23andMe a 10-year background in healthcare investing, focused primarily on biotechnology companies. Anne left the investing world with the hope that she could have a positive impact on research and medicine through 23andMe. From her vantage point, Anne saw a need for creating a way to generate more information – especially more personalized information – so that commercial and academic researchers could better understand and develop new drugs and diagnostics. By encouraging individuals to access and learn about their own genetic information, 23andMe will create a common, standardized resource that has the potential to accelerate drug discovery and bring personalized medicine to the public. (Plus, getting access to her own genetic information and understanding it has always been one of Anne’s ambitions.) Anne graduated from Yale University with a B.S. in biology.

http://blogs.wsj.com/health/2012/04/18/why-23andmes-anne-wojcicki-trusts-the-crowd-over-the-system/
Why 23andMe’s Anne Wojcicki Trusts the Crowd Over the System

http://www.theguardian.com/science/2013/nov/25/genetics-23andme-fda-marketing-pgs-screening

FDA orders genetics company 23andMe to cease marketing of screening service
Agency is ‘concerned about the public health consequences of inaccurate results from the PGS device’
Amanda Holpuch in New York  theguardian.com, Monday 25 November 2013 13.56 EST

 

http://venturebeat.com/2013/11/26/warning-letter-to-23andme-could-be-a-landmark-case-for-health-care/

Why the FDA is targeting Google-backed 23andMe: Unnecessary MRIs, mastectomies

 

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Anne Wojcicki Founder of 23andMe in Battle With FDA
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Anne Wojcicki Founder of 23andMe in Battle With FDA
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Anne Wojcicki, founder of the online genetic testing service 23andMe is now in a tooth and nail battle with the FDA.
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Jeffrey Dach MD
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