The assay uses the sandwich test format for the detection of GDF-15 in human serum


Roche branch offices in Basel. (Credit: F. Hoffmann-La Roche Ltd)

Roche has secured breakthrough device designation from the US Food and Drug Administration (FDA) for its Elecsys GDF-15 assay as a companion diagnostic (CDx) in cancer treatment.

Elecsys GDF-15 is an in vitro diagnostic immunoassay designated for measurement of Growth Differentiation Factor-15 (GDF-15) in cachectic patients 18 years of age and older with solid tumours to be treated with Pfizer’s investigational drug PF-06946860.

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

According to the company, cachexia affects over 30 million people across the globe and is a highly prevalent complication of cancer that is said to affect between 50 to 80% of all cancer patients.

Elecsys GDF-15 is a quantitative serologic and two-incubation step electrochemiluminescence immunoassay (ECLIA), which uses the sandwich test format to detect GDF-15 in human serum.

The GDF-15 assay, which is designed for use on cobas e immunoassay analysers, has a CE mark approval in various applications including risk prediction of major bleeding events of atrial fibrillation patients and risk stratification of patients with an acute coronary syndrome or chronic heart failure.

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.”

In December 2020, Roche expanded its Covid-19 test portfolio with the introduction of Elecsys SARS-CoV-2 antigen test in the CE mark accepting markets.

The test is developed for the in vitro qualitative detection of the nucleocapsid antigen of SARS‑CoV‑2.