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February 8, 2021

FDA grants breakthrough designation to Roche Elecsys GDF-15 assay

The US Food and Drug Administration (FDA) has granted breakthrough device designation to Roche’s Elecsys GDF-15 assay as a companion diagnostic (CDx) in cancer treatment. 

The US Food and Drug Administration (FDA) has granted Breakthrough Device Designation to Roche’s Elecsys GDF-15 assay as a companion diagnostic (CDx) in cancer treatment.

The in vitro diagnostic immunoassay is designed for measuring Growth Differentiation Factor-15 (GDF-15) in cachectic adult patients with solid tumours for treatment with Pfizer’s investigational drug PF-06946860.

Cachexia is a metabolic disorder and comorbidity that occurs with various chronic diseases such as cancer, heart failure, chronic obstructive pulmonary disease (COPD), and chronic kidney disease (CKD).

It manifests as marked involuntary body weight loss, muscle atrophy, and reduced appetite, advancing to functional impairment and high death risk.

Cachexia is a common complication of cancer, and affects more than half of cancer patients globally.

As elevated GDF-15 is linked to cachexia in cancer patients, successful cachexia treatment can potentially lead to better cancer treatment.

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Roche Diagnostics CEO Thomas Schinecker 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.”

Elecsys GDF-15 is a quantitative serologic, two-incubation step electrochemiluminescence immunoassay (ECLIA) that uses the sandwich test format for GDF-15 detection in serum of humans.

It is intended for use on cobas e immunoassay analysers.

GDF-15 is a CE approved for uses in cardiology such as risk prediction of major bleeding events of atrial fibrillation patients, risk stratification of patients with an acute coronary syndrome, or chronic heart failure.

Last month, Roche announced the CE-IVD launch of its automated digital pathology algorithms for breast cancer to help to select the best treatment approach for each patient.

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