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.
Jeffrey Michael Yunes - Comment
This is comment on Notice
Meetings: Molecular and Clinical Genetics Panel of Medical Devices Advisory Committee
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