Amgen, Biocartis Sign Companion Diagnostic PactBy
Amgen has signed a companion diagnostic (CDx) development agreement with Biocartis Group, a Mechelen, Belgium-headquartered molecular diagnostics company, for Biocartis’ Idylla 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), a drug for treating a certain type of metastatic colorectal cancer (mCRC).
RAS testing is a predictive biomarker to determine a treatment plan for patients with mCRC, according to information from Biocartis.
The CDx agreement builds on Amgen’s and Biocartis’ 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.
Under the agreement, Biocartis will pursue a premarket approval for the Idylla KRAS Mutation Test and the Idylla NRAS-BRAF Mutation Test with the FDA. Amgen will provide financial and operational support to Biocartis for the PMA process.