FDA grants BDD for Roche’s Elecsys GDF-15 assay addressing cancer weight loss

Roche has revealed that their assay Elecsys® GDF-15 assay has been approved as a companion diagnostic (CDx) in cancer therapy and given Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA).

The in vitro diagnostic immunoassay is designed to evaluate Growth Differentiation Factor-15 (GDF-15) in cachectic patients 18 years of age and older with solid tumors for treatment of Pfizer’s investigational drug PF-06946860.

Unintentional weight loss (cachexia) affecting more than 50% of all cancer patients worldwide

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). More than 30 million people globally are affected by the condition. Cachexia is expressed as notable involuntary body weight loss, muscle atrophy, and reduced appetite, progressing to significant functional impairment and heightened risk of death. Elevated GDF-15 is associated with cachexia in cancer patients. Cachexia is a widespread complication of cancer, affecting between 50 to 80% of all cancer patients, depending on the tumour type, the patient response to tumour progression and on individual body types.

Thomas Schinecker, CEO Roche Diagnostics said:

“We are pleased to partner with Pfizer to address this unmet medical need in oncology through strong companion 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.”

About the Elecsys Growth Differentiation Factor-15 (GDF-15) assay

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 Pfizer’s PF-06946860. The electrochemiluminescence immunoassay “ECLIA” is meant 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.

About Cachexia

Cachexia affects more than 30 million people around the world but is not well understood due to its complexity. Traditionally it has been viewed as a complication of chronic diseases or end stages of cancer. The difficulties 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, lowered effectiveness of chemotherapy, impaired mobility and reduced functionality of muscle-dependent systems, such as the respiratory and cardiovascular systems, leading to decreased quality of life and rate of survival.

About Roche

Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.


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