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Biocartis and Amgen Sign Companion Diagnostic Agreement for Idylla(TM) RAS Biomarker Tests

Biocartis Group NV (the 'Company' or 'Biocartis'), an innovative molecular diagnostics company (Euronext Brussels: BCART), today announced the signing of a companion diagnostic[1] (CDx) development agreement with Amgen, a leading biotechnology company (NASDAQ: AMGN), for the Idylla(TM) RAS biomarker tests. The aim of the agreement is to register the Idylla(TM) 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[2].

RAS testing is an essential predictive biomarker to determine the treatment plan for patients with mCRC. Today, RAS testing in the US is not performed systematically for all patients, and if done, results can be delayed, which can affect patients' outcomes.

The CDx agreement further builds on Biocartis' and Amgen's collaborations[3] 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(TM) platform and Idylla(TM) RAS biomarker tests. US FDA approval of the Idylla(TM) 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.

Under the agreement, Biocartis will pursue a premarket approval (PMA[4]) for the Idylla(TM) KRAS Mutation Test and the Idylla(TM) NRAS-BRAF Mutation Test with the US FDA. Amgen will provide financial and operational support to Biocartis for the PMA process.

The two Idylla(TM) 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) tumor slices.

Ulrik Cordes, EVP Companion Diagnostics of Biocartis, commented: "We are very pleased to further strengthen our collaboration with Amgen. This new agreement is a testimony to what the Idylla(TM) 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(TM) 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 personalized medicine for colorectal cancer, and we are committed to advancing patient care with the identification of appropriate biomarkers to aid optimal treatment selection,&quo