In Big Step for Microarray-based Diagnostics, Affy and Roche File AmpliChip for FDA Approval | GenomeWeb

Affymetrix and Roche Diagnostics have each filed products comprising their CYP450 AmpliChip microarray for US Food and Drug Administration approval as a de novo 510(k) in vitro diagnostic, Pharmacogenomics Reporter has learned.

The CYP450 microarray is comprised of Affy’s GeneChip 3000Dx reader and Roche’s CYP450 AmpliChip, both of which attained a Conformité Européene Mark in early September.

A Roche spokesperson confirmed the company had filed the AmpliChip with the FDA.

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.

In PLOS this week: nasal microbial communities in asthma patients; sequencing-based way to detect, track schistosomiasis; and more.

The New York Times speaks with Vanderbilt's John Anthony Capra about Neanderthal genes in modern humans.

A draft guidance from the FDA suggests the agency wants to more tightly control gene-edited animals, according to Technology Review.

Researchers were among this weekend's protesters bemoaning the new US administration, Vox reports.