FDA Approves ‘23ANDME’ for Genetic Testing Against Rare Conditions

FDA Approves ‘23ANDME’ for Genetic Testing Against Rare Conditions

by Kurt Knutsson


FDA approved ‘23andme‘ to test for rare genetic issues, DNA tests and screenings. After years of rocky relations between personal genomics company 23andMe and the Food and Drug Administration (FDA), it appears that CEO Anne Wojcicki got her foot in the door and is prying open the regulatory agency’s previous reluctant stance in approving 23andMe’s DNA saliva test.  The way it works is simple and fascinating.  You spit into a cylinder then FedEx it back to 23andMe to determine what your 24 chromosomes say about your heritage, health risks and where your DNA from both parents point on a map for your origin in the world. In 2013, the FDA forced 23andMe to stop offering its health related results in the U.S. citing the fact that the genomics company suddenly walked away from discussions while attempting to comply with the FDA.  Lucky for me, I was offered the DNA test back in 2007 and am still able to access results.  Some doctors criticize the way the health information can lead hypochondriacs to interpret health risks in a way that causes undue stress and anxiety.

I’m glad I did the test, but still to this day choose not to unlock the health risk assessments for catastrophic illnesses that we currently cannot treat.  If I’m to have the likelihood of a disease that will run me over like a bus and there is nothing I can do about it, I simply don’t need to know.  I think it would take away from my enjoyment of life.  Others feel the opposite way saying that if you know your days are numbered, you might choose a more robust existence.

It’s no surprise that 23andMe has lowered its test to $99 in order to get more DNA samples to study. It likely will one day offer the collective information of a large DNA sample to pharmaceutical companies and for medical research in a way to make it profitable.  Maybe that’s why Google made a $3.9M investment early on.  That may have also come about more easily since 23andMe’s CEO is also the wife of Google co-founder Sergey Brin.

It turns out there is also more at stake for the Google billionaire.  Brin’s DNA test revealed a gene called LRRK2 within the 12th chromosome known as a genetic mutation associated with a 30 to 75 percent increased chance that he will develop Parkinson’s at some point in his life.  That also led him to understand how he can change his life today with the little information known about Parkinson’s to reduce his risk.  Studies show that increased regular exercise for young men, consuming coffee and smoking cigarettes can lead to a reduced risk of developing Parkinson’s.

While he opted not to take up smoking, he did ramp up his regular exercise and despite disliking coffee, he tried it long enough to realize that green tea might better suit his caffeine needs.  Sergey Brin’s DNA test has further inspired a personal $50M contribution to Parkinson’s research hoping he can move the needle toward a possible cure.

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