FDA Clears Agendia's MammaPrint Dx; First IVDMIA to Get Green Light | GenomeWeb
NEW YORK (GenomeWeb News) — The US Food and Drug Administration yesterday said it has cleared Agendia’s MammaPrint diagnostic for breast cancer recurrence.
 
The test is the first in vitro diagnostic multivariate index assay device approved by the agency since it released a draft guidance describing such products last year.
 
As GenomeWeb News reported last fall, IVDMIAs use mathematical formulas to interpret gene and protein data to guide medical decision-making, according to the draft guidance, which can be read here.

Get the full story

This story is free
for registered users

Registering provides access to this and other free content.

Register now.

Already have an account?
Login Now.

The final text of the bill to reauthorize the America COMPETES Act might smooth over the differences between NSF and the House science committee, ScienceInsider says.

Four Republican lawmakers urge President-elect Donald Trump to keep Francis Collins as NIH director, Stat News reports.

In Genome Research this week: Platinum variant catalog, algorithmic strategy for upgrading fragmented assemblies, and more.

Sequencing of a 10,000-year-old mummy leads to its repatriation to the Fallon Paiute-Shoshone Tribe, Nature News reports.