FDA, Exact Sciences, Nanosphere, Roche, RBM | GenomeWeb
FDA Warns Exact Sciences that CRC Assay Requires Premarket Approval
 
Exact Sciences said this week that it has received a warning letter from the US Food and Drug Administration notifying the company that its colorectal cancer screening assay will require premarket approval.
 
In the letter, the FDA's Office of In Vitro Diagnostics Device Evaluation and Safety said it believes the company’s DNA-based PreGen-Plus assay is a medical device and therefore requires premarket approval or clearance.

Get the full story with
GenomeWeb Premium

Only $95 for the
first 90 days*

A trial upgrade to GenomeWeb Premium gives you full site access, interest-based email alerts, access to archives, and more. Never miss another important industry story.

Try GenomeWeb Premium now.

Already a GenomeWeb Premium member? Login Now.
Or, See if your institution qualifies for premium access.

*Before your trial expires, we’ll put together a custom quote with your long-term premium options.

Not ready for premium?

Register for Free Content
You can still register for access to our free content.

Fast Company takes a look at startups in the nutrigenomic space that aim to offer personalized diet advice.

In a glamorous event, the Breakthrough Foundation gave out more than $25 million in prizes to researchers.

Immunotherapy might treat cancer, but it also appears to come with a risk of a number of side effects, the New York Times reports.

In PLOS this week: RNA-seq, ChIP-seq to determine metformin response; array-based approach to detect protozoa in blood; and more.