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Roche : FDA Grants Breakthrough Device Designation To Elecsys GDF-15 Assay

The U.S. Food and Drug Administration has granted breakthrough device designation for Roche's (RHHBY) Elecsys growth differentiation factor-15 or GDF-15 assay to help identify patients suitable for treatment addressing unintentional weight loss in cancer patients, Roche said in a statement.

According to Roche, the FDA acknowledged the importance of GDF-15 testing in identifying eligible cachexic patients with solid tumours to be treated with Pfizer's investigational drug PF-06946860.

The unintentional weight loss or cachexia is a highly prevalent complication of cancer, affecting more than half of all cancer patients worldwide, potentially leading to significant functional impairment and increased risk of death.

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.

Elecsys GDF-15 is a quantitative serologic, two-incubation step electrochemiluminescence immunoassay or ECLIA using the sandwich test format for the detection of GDF-15 in human serum. The Elecsys GDF-15 assay is indicated as an aid in identifying cachectic patients 18 years of age and older with solid tumours for treatment with PF-06946860.

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