FDA grants Breakthrough Device Designation for Roche's Elecsys growth differentiation factor-15 assay

Roche has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to their Elecsys^® GDF-15 assay as a companion diagnostic (CDx) 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 tumors for treatment with Pfizer Inc.'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 (COPD), and chronic kidney disease (CKD). It impacts more than 30 million people globally. Cachexia manifests as marked involuntary body weight loss, muscle atrophy, and reduced appetite, progressing to significant functional impairment and increased risk of death. Elevated GDF-15 is associated with cachexia in cancer patients. Cachexia is a highly prevalent complication of cancer, affecting between 50 to 80% of all cancer patients. This range depends on the tumor type, the patient response to tumor progression and on individual body type.

“We are pleased to partner with Pfizer to address this unmet medical need in oncology through strong companion diagnostics”, said Thomas Schinecker, CEO Roche Diagnostics. “The FDA BDD grant for the Elecsys GDF-15 assay shows the importance of these strong partnerships. 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.”

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