Advertisement

If you have an ACS member number, please enter it here so we can link this account to your membership. (optional)

ACS values your privacy. By submitting your information, you are gaining access to C&EN and subscribing to our weekly newsletter. We use the information you provide to make your reading experience better, and we will never sell your data to third party members.

ENJOY UNLIMITED ACCES TO C&EN

Pharmaceuticals

FDA To Act On Diagnostic Tests

by Britt E. Erickson
August 11, 2014 | A version of this story appeared in Volume 92, Issue 32

FDA is taking steps to increase its oversight of certain tests, used to diagnose and treat patients, to ensure the accuracy and reproducibility of the tests. A draft proposal released on July 31 takes aim at diagnostic tests that are developed and used in a single laboratory, such as genetic tests used by medical professionals to guide treatment for a particular patient. Under the draft proposal, tests that pose high or moderate risks to patients would be subject to premarket approval, which requires clinical studies. Historically, FDA has not required clinical studies for this category of diagnostics. As a result, some of these tools have entered the market without safety data and are directly competing with FDA-approved diagnostics. Under the draft proposal, FDA would consider diagnostics high risk if they have the same intended use as tests that are already FDA approved.

Article:

This article has been sent to the following recipient:

0 /1 FREE ARTICLES LEFT THIS MONTH Remaining
Chemistry matters. Join us to get the news you need.