Empowering Consumers through Accurate Genomic Tests
By Jeffrey Shuren,
FDA Voice
| 06. 26. 2014
Untitled Document
We’ve come to recognize that almost every disease has a genetic component, and many consumers now are eager to know more about their genetic profiles. They need only send a sample of their DNA collected from their saliva or from a cheek swab to a company, and in exchange they’ll get back information about their genetic risk for development of future disease.
FDA understands and supports people’s interest in having access to their genetic information and believes such information can help them make more informed choices about their health – so long as that genetic information is accurate – that the results are correct, meaningful and written in a way that consumers can understand. FDA reviews genetic tests for medical conditions, whether they are intended to be ordered by a healthcare practitioner or directly by the consumer, to assure that consumers receive accurate test results.
Telling someone they are at high risk for a life-threatening cancer when they are not—or that they are at low risk for diabetes when they actually are at high risk for this chronic...
Related Articles
By Megan Molteni and Anil Oza, STAT | 10.07.2025
For two years, a panel of scientific experts, clinicians, and patient advocates had been hammering out ways to increase community engagement in National Institutes of Health-funded science. When they presented their road map to the NIH Director Jay Bhattacharya last...
Paula Amato & Shoukhrat Mitalipov
[OHSU News/Christine Torres Hicks]
On September 30th, a team of 21 scientists from Oregon Health & Science University (OHSU) published a significant paper in Nature Communications, with a scientifically accurate but, to many, somewhat abstruse headline:
Induction of experimental cell division to generate cells with reduced chromosome ploidy
The lead authors were Shoukhrat Mitalipov, recently described here as “a push-the-envelope biologist,” and his long-term colleague Paula Amato. (Recall that in July the pair had co-published with...
By Pam Belluck, The New York Times | 10.17.2025
Before dawn on a March morning, Doug Whitney walked into a medical center 2,000 miles from home, about to transform from a mild-mannered, bespectacled retiree into a superhuman research subject.
First, a doctor inserted a needle into his back to...
By Julia Black, MIT Technology Review | 10.16.2025
Consider, if you will, the translucent blob in the eye of a microscope: a human blastocyst, the biological specimen that emerges just five days or so after a fateful encounter between egg and sperm. This bundle of cells, about the size of...
