Category: Elecsys

Roche’s Elecsys GDF-15 Assay Receives the US FDA’s Breakthrough Device Designation as a CDX in Cancer Treatment

Shots: The US FDA grants the BDD for Elecsys GDF-15 assay that is intended for measurement of Growth Differentiation Factor-15 (GDF-15) in cachectic patients aged≥18yrs. with solid tumors for treatment with Pfizer’s PF-06946860 GDF-15 assay helps to identify patients suitable for innovative treatment addressing unintentional weight loss in cancer patients and may provide a precision […]

Roche’s Elecsys Anti-SARS-CoV-2 S Receives the US FDA’s EUA to Detect Ab Against SARS-CoV-2 Spike Protein

Shots: The US FDA’s EUA follows the launch of the Elecsys Anti-SARS-CoV-2 S Ab test for markets accepting the CE Mark. The serology test can be used to measure the level of Abs in people who have been exposed to the SARS-CoV-2 virus The test has both a high NPA of 99.98% and PPA of […]