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 PNAS this week: transcript patterns in drug-resistant cancer cells, function of high-altitude adaption gene, and more.

Monitoring gene expression changes could help sniff out athletes using performance-enhancing drugs, New Scientist says.

The University of Southern California lodges a cross-complaint in its legal dispute with the University of California, San Diego, over a large Alzheimer's disease project.

In PLOS this week: gene fusion in premature ovarian failure, population patterns in the Franciscana dolphin, and more.