Biocartis Group NV, an innovative molecular diagnostics company from Belgium, announced the signing of a companion diagnostic development agreement with Amgen, a leading biotechnology company, for the RAS biomarker tests.
The aim of the agreement is to register the Idylla™ RAS biomarker tests with the US Food and Drug Administration (FDA) as a companion diagnostic test for Amgen’s drug Vectibix (panitumumab). Vectibix is the first and only fully human monoclonal anti-epidermal growth factor receptor (EGFR) antibody indicated for certain metastatic colorectal cancer (mCRC) patients with wild-type RAS. RAS testing is an essential predictive biomarker to determine the treatment plan for patients with metastatic colorectal cancer (mCRC).
The agreement further builds on Biocartis’ and Amgen’s collaborations in Europe that are focused on accelerating results of RAS biomarker testing from up to one month to, in principle, same-day results for mCRC patients, using Biocartis’ Idylla platform and Idylla RAS biomarker tests.