Biocartis and Amgen sign CDx development agreement for biomarker tests

Molecular diagnostics company, Biocartis, has signed a companion diagnostic (CDx) development agreement with biotechnology company, Amgen, for the Idylla RAS biomarker tests.

The aim of this agreement is to register the biomarker tests with the US Food and Drug Administration (FDA) as a companion diagnostic test for Amgen’s drug Vectibix (panitumumab). Vectibix is a fully human monoclonal anti-epidermal growth factor receptor (EGFR) antibody indicated for certain metastatic colorectal cancer (mCRC) patients with wild-type RAS.

This agreement further builds on the companies’ relationship within Europe, focussing 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. FDA approval of the Idylla RAS biomarker tests could allow for a more widespread RAS clinical testing, regardless of the clinical practice size, available lab infrastructure or experience level, and could enable same-day turnaround times.

“We are very pleased to further strengthen our collaboration with Amgen,” commented Ulrik Cordes, EVP Companion Diagnostics of Biocartis. “This new agreement is a testimony to what the Idylla technology can bring to patients in helping to overcome the current challenges of RAS testing in the US market. 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. This is very much in line with the core of our mission to make personalized medicine an everyday reality.”

“Amgen has been a pioneer in personalised medicine for colorectal cancer, and we are committed to advancing patient care with the identification of appropriate biomarkers to aid optimal treatment selection,” added Greg Friberg, vice president of Global Development, Oncology at Amgen. “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.”

Under the terms of the agreement, Biocartis will pursue a premarket approval (PMA) 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.

The two Idylla RAS biomarker tests together allow for a simultaneous detection of 44 clinically relevant mutations for colorectal cancer, operating directly from formalin-fixed paraffin embedded (FFPE) tumour slices.

Financial details on the CDx agreement with Amgen were not disclosed.