• Direct To Consumer Genetic Testing

    by Sharan Abdul-Rahman, MD
    on Feb 24th, 2015

On February 19, 2015, the US FDA authorized direct to consumer marketing of genetic testing for Bloom Syndrome by the company 23andMe.

Bloom syndrome is rare inherited autosomal recessive genetic disorder meaning both parents have passed on a comparable mutated gene to their child. Persons with Bloom syndrome have an increased risk of cancer(s) which usually occur early in the life.

According to Dr. Alberto Gutierrez, the director of the Office of In Vitro Diagnostics and Radiological Health in the FDA's Center of Devices and Radiological Health,"The FDA believes that in many circumstances it is not necessary for consumers to go through a licensed practitioner to have direct access to their personal genetic information.."

Currently, prenatal genetic screening involves obtaining a detailed family history for both parents and selective genetic testing for those at high risk based on history, ethnicity and age. As patients (consumers) purchase genetic information, opportunities to advise regarding the significance and the limitations of these tests will increase.

Author Sharan Abdul-Rahman, MD

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