The FDA cleared Roche's Elecsys BRAHMS PCT electrochemiluminescence immunoassay for an expanded use to aid in antibiotic therapy decision-making.
The investigators noted that the Siemens assay enables more institutions to introduce high-sensitivity cardiac troponin testing for patients outside the US.
The FDA said that pooled testing of donations using a screening test that it has licensed is a sufficient method for complying with its testing regulations.
With a University of Missouri partnership, Roche is testing the combination of data from disparate sources and furthering the integration of several recent acquisitions.
Month over month, the 360Dx Index beat the Dow Jones Industrial Average, the Nasdaq Composite, and the Nasdaq Biotech Index.
In the last year, both Sciex and Thermo Fisher have launched clinical platforms, but whether they will prove commercial successes remains to be seen.
The trial, part of a multiyear effort to standardize HbA1c testing in labs, will be repeated annually with more labs participating and more countries represented.
Clinicians were surprised by a recent NEJM study that found that using procalcitonin assays did not reduce the use of antibiotics.
Under a definitive merger agreement, Roche will acquire outstanding shares of Foundation's common stock for $137 per share.