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# Roche Breakthrough Status for Companion Diagnostic
- URL: https://www.fdaweb.com/roche-breakthrough-status-for-companion-diagnostic/
- Published: 2021-02-08T12:00:00.000Z
- Updated: 2026-09-14T16:45:48.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5148613

FDA has granted Roche a breakthrough device designation for its Elecsys GDF-15 assay as a companion diagnostic (CDx) in cancer treatment. The in vitro diagnostic immunoassay is intended to measure Growth Differentiation Factor-15 (GDF-15) in cachectic patients 18 years of age and older with solid tumors for treatment with Pfizer’s investigational drug PF-06946860\. Cachexia is a metabolic disorder and comorbidity that occurs with several chronic diseases including cancer, heart failure, chronic obstructive pulmonary disease, and chronic kidney disease, Roche says.

Roche says Cachexia is a highly prevalent cancer-related complication, affecting between 50% to 80% of all cancer patients. “The ability to detect elevated GDF-15 in patients who are experiencing weight loss may provide a precision-medicine approach to identifying patients likely to respond to a GDF-15 therapeutic treatment,” it says.

Elecsys GDF-15 is a quantitative serologic, two-incubation step electrochemiluminescence immunoassay using a “sandwich test format” for detecting it in human serum, Roche says. The assay is intended for use on cobas-e immunoassay analyzers.