Under the terms of the agreement, the companies will work towards registering the tests with the US Food and Drug Administration (FDA) as a companion diagnostic test for Amgen’s Vectibix (panitumumab) drug.
Vectibix is a fully human monoclonal antibody of anti-epidermal growth factor receptor (EGFR) developed for select metastatic colorectal cancer (mCRC) patients with wild-type RAS.
RAS testing is used as a predictive biomarker to establish a treatment plan for mCRC patients.
Biocartis Companion Diagnostics executive vice-president Ulrik Cordes said: “Pursuing US FDA approval of our CDx Idylla RAS tests, in collaboration with Amgen, 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.”
The agreement covers the Idylla KRAS and NRAS-BRAF Mutation Tests and will seek FDA premarket approval (PMA ), which will be financially and operationally supported by Amgen.
The tests together enable simultaneous detection of 44 clinically relevant mutations for the cancer.
Amgen Oncology Global Development vice-president Greg Friberg said: “We know that mutation status provides actionable information when deciding on a first-line treatment option in mCRC patients.
“We are excited to collaborate with Biocartis to apply novel technologies as we seek to deliver expedited RAS biomarker test results that will help to identify patients that may benefit the most from Vectibix.”