By Adam Bonislawski

As the US Food & Drug Administration refines its policies regarding in vitro diagnostic multivariate index assays, attention to assay reproducibility issues and selection of appropriate intended use populations will be key to the success of proteomics-based tests, FDA staff fellow Joshua Levin suggested at a talk this week discussing the agency's 2009 review of two mock 510(k) submissions for protein IVDMIAs.

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?

Browse our free articles
You can still register for access to our free content.