Posted by Michael Wonder on 08 Feb 2021
FDA grants breakthrough device designation for Roche's Elecsys growth differentiation factor-15 assay to help identify patients suitable for innovative treatment addressing unintentional weight loss in cancer patients
8 February 2021 - FDA BDD acknowledges the importance of GDF-15 testing in identifying eligible cachexic patients with solid tumours to be treated with Pfizer's investigational drug PF-06946860.
Roche announced today that the U.S. FDA has granted breakthrough device designation to their Elecsys GDF-15 assay as a companion diagnostic in cancer treatment.
This in vitro diagnostic immunoassay is intended for measurement of Growth Differentiation Factor-15 (GDF-15) in cachectic patients 18 years of age and older with solid tumours for treatment with Pfizer's investigational drug PF-06946860.
