Roches Elecsys GDF-15 Assay As A Companion Diagnostic In Cancer Treatment Receives US FDA Breakthrough Device Designation

Roche announced that the US 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 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 tumour type, the patient response to tumour 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.”Elecsys GDF-15 is a quantitative serologic, two-incubation step electrochemiluminescence immunoassay (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. The electrochemiluminescence immunoassay “ECLIA” is intended for use on cobas e immunoassay analyzers. GDF-15 has CE approval in several intended uses in cardiology including risk prediction of major bleeding events of atrial fibrillation patients, risk stratification of patients with acute coronary syndrome or chronic heart failure.Cachexia impacts more than 30 million people globally but is poorly understood due to its complexity. It has traditionally been seen as a complication of chronic diseases or end stages of cancer. The burden cachexia poses on patients, their caregivers and loved ones, as well as the healthcare system, is significant. Cancer cachectic patients experience numerous complications including, but not limited to, reduced effectiveness of chemotherapy, reduced mobility and reduced functionality of muscle-dependent systems, such as the respiratory and cardiovascular systems, leading to decreased quality of life and survival.

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