Sign In

Communications of the ACM

ACM News

A Turning Point For Genetic Testing


View as: Print Mobile App Share: Send by email Share on reddit Share on StumbleUpon Share on Hacker News Share on Tweeter Share on Facebook
Genetic testing

Technology Review

In a prelude to overhauling its regulatory oversight of genetic diagnostic testing, the U.S. Food and Drug Administration will convene a public meeting next week to gather input from test makers and others.

The event reflects a turning point in genetic testing, a cornerstone of personalized medicine. Once mainly the domain of rare diseases, scientists have discovered a growing number of genetic variations linked to both the risk of more common disease and patients' response to drugs. The number of genetic diagnostic tests has expanded rapidly, and tests have become increasingly complex, making it more challenging to interpret and act on the results.

"We don't think physicians are going to be able to interpret the results; they are relying on the labs that make them," says Alberto Gutierrez, director of the Office of In Vitro Diagnostic Device Evaluation and Safety at the FDA. "So we think a third party should assess these devices."

From Technology Review
View Full Article


 

No entries found