The US Food and Drug Administration last week issued a draft guidance to industry that signaled its wish to begin regulating tests that use algorithms to interpret gene and protein data.
 
The devices, which the FDA calls in vitro diagnostic multivariate index assays, are relatively new to the market and are currently used by CLIA labs as homebrew tests. But some FDA officials believe they are growing at such a rapid pace that they have raised concerns about their impact on patient care.
 

Get the full story with
GenomeWeb Premium

Only $95 for the
first 90 days*

GenomeWeb Premium gives you:
✔ Full site access
✔ Interest-based email alerts
✔ Access to archives

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.

Researchers report using genotyping to tie together illegal ivory shipments and trace them back to a handful of cartels, the New York Times reports.

Researchers find that historical factors influence which genes are the most highly studied, the Atlantic reports.

The US National Science Foundation's new sexual harassment policy is to go into effect next month, according to Nature News.

In Nature this week: genomic ancestry analysis of Sardinians, current noncoding mutations in colorectal cancer, and more.

Oct
10
Sponsored by
Philips Genomics

This webinar will provide a first-hand look at how the Dana-Farber Cancer Center is adapting its oncology care strategy in light of the rapidly evolving molecular landscape.