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 medicine approach to identifying patients likely to respond to a GDF-15 treatment
- Elecsys GDF-15 is a quantitative serologic- two-incubation step ECLIA using the sandwich test format for the detection of GDF-15 in human serum
Ref: GlobeNewswire | Image: Roche
Click here to read the full press release
This content piece was prepared by our former Senior Editor. She had expertise in life science research and was an avid reader. For any query reach out to us at connect@pharmashots.com