NEW YORK (GenomeWeb) – Biocartis announced today that it has signed a companion diagnostic development agreement with Amgen for its Idylla RAS biomarker tests.
Under the terms of the agreement, Biocartis will seek a premarket approval for the Idylla KRAS Mutation Test and the Idylla NRAS-BRAF Mutation Test with the US Food and Drug Administration, as companion diagnostic tests for Amgen's Vectibix (panitumumab), a monoclonal anti-epidermal growth factor receptor antibody approved to treat certain metastatic colorectal cancer patients with wild-type RAS. The two Idylla biomarker tests allow for the simultaneous detection of 44 clinically relevant colorectal cancer mutations from formalin-fixed paraffin embedded tumor slices, Biocartis said.
Amgen said it will provide financial and operational support to Biocartis for the PMA process. Further financial details of the agreement were not disclosed.
"Pursuing US FDA approval of our CDx Idylla RAS tests… will enable laboratories throughout the US to reduce waiting times and provide timely access to biomarker status for the optimal selection of therapies for colorectal cancer patients," Ulrik Cordes, Biocartis' executive vice president of companion diagnostics, said in a statement. Â
The two firms signed a deal in early 2016 under which the Idylla RAS biomarker tests would be made available by Amgen to reference hospitals in Brazil, Canada, Columbia, Mexico, Saudi Arabia, Spain, and Turkey.