Jeffrey Michael Yunes - Comment

Document ID: FDA-2011-N-0066-0005
Document Type: Public Submission
Agency: Food And Drug Administration
Received Date: February 21 2011, at 12:00 AM Eastern Standard Time
Date Posted: March 3 2011, at 12:00 AM Eastern Standard Time
Comment Start Date: February 7 2011, at 12:00 AM Eastern Standard Time
Comment Due Date: March 1 2011, at 11:59 PM Eastern Standard Time
Tracking Number: 80bf481f
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Direct-to-Consumer genetic testing companies are very clear about the chance of error. In fact, my last doctor-prescribed lab result came without any warning. Errors in Direct-to-Consumer genetic tests are further mitigated by the fact that they predict physical traits, such as hair color and earwax type, which consumers see as controls. If prescriptions are required, it would be very unlikely for someone to get one for a genetic test of hair color, to act as a control. The competition between different genetic testing companies keeps them vying for consumers' trust through more reliable predictions. Regulation will, to some degree, prevent some companies from entering the competition, even if those companies start off as weak contenders. Should it be illegal for everyone to know their respective genetic blueprints without a medical reason? It seems to me that an answer in the affirmative is a gross violations of the 9th and 10th amendments. As a Ph.D. student in bioinformatics, being able to explore my own genome is one of the things that motivates me.

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