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

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

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  • 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 

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