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23andMe Launches New Health Tests, Navigates FDA Regulations - iHealthBeat

Consumer driven genomic testing joins consumer driven laboratory testing.

Both promise to reduce health care costs. But, will established laboratories oppose these efforts. The disruption will be massive.  The key issue is FDA approval and reliability of results.

The development pipeline may be altererd forever.

Elizabeth Holmes, CEO and owner of Theranos states that publishing basic research in peer reviewed journals takes too much  time and expensive delays.  She prefers subitting to the FDA directly.  But does the FDA have the manpower to establish reliability and repeatability of that data ?

Background on 23andMe

On Wednesday, genetic testing company 23andMe announced that it will provide customers with health information again, but in a more limited capacity because of continuing regulatory involvement from FDA, the New York Times reports.

23andMe Co-Founder and CEO Anne Wojcicki launched the company with investments from her then-husband Google Co-Founder Sergey Brin (Pollack,New York Times, 10/21). 23andMe launched its first genetic test, the Personal Genome Service, in 2007 (Humer/Steenhuysen, Reuters, 10/21). The company said its original $99 test could predict a likelihood of developing conditions such as:
  • Alzheimer's disease (Perrone, AP/Sacramento Bee, 10/21);
  • Breast and ovarian cancer;
  • Certain heart conditions (Reuters, 10/21); and
  • Parkinson's disease (AP/Sacramento Bee, 10/21).
However, FDA in 2013 ordered 23andMe to halt sales of the service because the tests had not received FDA approval (Reuters, 10/21). Since then, the company has used the genetic data it collected to fuel drug research and has focused on analyzing family history and ancestry, which is not FDA-regulated. More than one million people have used 23andMe's saliva-based test to learn about their genetic code (AP/Sacramento Bee, 10/21).

Details of 23andMe's New Testing Service

About eight months ago, FDA approved 23andMe's carrier screening test for Bloom Syndrome, a disorder that causes short stature and a predisposition to cancer. FDA then reclassified such carrier screening tests as Class II medical devices, meaning they no longer require premarket approval, which involves clinical trials. 
On Wednesday, 23andMe debuted a new $199 carrier screening test that can predict whether a person will pass on one of 36 conditions to a child, including:
  • Beta thalassemia;
  • Cystic fibrosis;
  • Sickle cell anemia; and
  • Tay-Sachs disease (Reuters, 10/21).
In addition, the test can predict non-medical traits, including:
  • Eye color;
  • Earwax composition (New York Times, 10/21);
  • Freckles;
  • Hair curliness; and
  • Lactose intolerance (Reuters, 10/21).
In addition, 23andMe still is working toward gaining FDA approval for personal tests predicting an individual's likelihood of developing specific diseases and how that individual might respond to specific drugs

23andMe Launches New Health Tests, Navigates FDA Regulations - iHealthBeat

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