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 David Jensen, California Stem Cell Report | 02.10.2026
Touchy issues involving accusations that California’s $12 billion gene and stem cell research agency is pushing aside “good science” in favor of new priorities and preferences will be aired again in late March at a public meeting in Sacramento.
The...
By Lauren Hammer Breslow and Vanessa Smith, Bill of Health | 01.28.2026
On Jan. 24, 2026, the New York Times reported that DNA sequences contributed by children and families to support a federal effort to understand adolescent brain development were later co-opted by other researchers and used to publish “race science”...
By Arthur Lazarus, MedPage Today | 01.23.2026
A growing body of contemporary research and reporting exposes how old ideas can find new life when repurposed within modern systems of medicine, technology, and public policy. Over the last decade, several trends have converged:
- The rise of polygenic scoring...
By Stephanie Pappas, LiveScience | 01.15.2026
Genetic variants believed to cause blindness in nearly everyone who carries them actually lead to vision loss less than 30% of the time, new research finds.
The study challenges the concept of Mendelian diseases, or diseases and disorders attributed to...