Articles

Archive for November 27th, 2013

The FDA and Personalized Genetic Testing

The company 23andMe provides personal genetic testing from a convenient home saliva sample kit. Their home page indicates that their $99 genetic screening will provide reports on 240+ health conditions in addition to giving you information on your genetic lineage. The benefits, they claim, are that you will learn about your carrier status and therefore the risk of passing on genetic diseases to your children. The information will also inform you about health risks so that you can change your behavior to manage them. Finally the genetic information will tell you about how you might respond to different drugs so that you can “arm your doctor with information.”

The home page also contains a link to testimonials about how their DNA testing has changed people’s lives.

This all sounds great – the promise of genomics that we have been hearing about now for about two decades. Isn’t this exactly what we were led to expect once we mapped the human genome?

Why, then, has the FDA recently sent a warning letter to 23andMe instructing them to discontinue marketing their Personal Genome Service (PGS)?

The primary reason appears to be a lack of documentation for the validity and reliability of the tests, but I have concerns that go even deeper. (more…)

Posted in: Public Health

Leave a Comment (79) →