In Brief This Week: Beckman Coulter, FDA; Siemens, Janssen Pharmaceutica; AMP, FASEB; Broad Institute, Agilent; More | GenomeWeb

NEW YORK (GenomeWeb News) – The US Food and Drug Administration this week gave 510(k) clearance to Beckman Coulter's Access AccuTnl+3 troponin l assay for use on the company's Access 2 immunoassay system.

In order to gain the long-awaited clearance, Beckman Coulter conducted a prospective clinical trial for the assay that included the enrollment of more than 1,900 subjects, following guidance from FDA in 2010 that manufacturers of troponin assays modernize the performance evaluation and regulatory review of such tests, the company said.

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.

In Cell this week: phosphoproteomic patterns in prostate cancer, effect of gene expression on fitness in yeast, and more.

Scripps Research Institute investigators peer back at the RNA world.

Being born premature shouldn't mean infants with high blood sugar levels don't undergo genetic testing for neonatal diabetes, a study in Pediatrics says.

In PNAS this week: chromosome instability in S. cerevisiae, structural differences and sequence divergence in rice, and more.