Biocartis Enters into Master Collaboration Agreement with AstraZeneca and Initiates EGFR Liquid Biopsy Study

Mechelen, Belgium, 22 January 2020 – Biocartis Group NV (the ‘Company’ or ‘Biocartis’), an innovative molecular diagnostics company (Euronext Brussels: BCART), today announces that it has entered into a master collaboration agreement with AstraZeneca, a global science-led biopharmaceutical company (LON/STO/NYSE: AZN). The master collaboration agreement enables the collaborative development and commercialization of Idylla™ based molecular tests in support of AstraZeneca’s pharmaceutical products.

The announcement today marks a broadening of the existing partnership¹ between Biocartis and AstraZeneca that focused on demonstrating how the unique features of the Idylla™ platform can overcome the current complexity and long turnaround time of biomarker testing for lung cancer patients. The prospective study with the tissue-based Idylla™ EGFR Mutation Test (CE-IVD) under the existing partnership was initiated at more than a dozen sites in several European countries. In addition to the new master collaboration agreement, AstraZeneca and Biocartis have agreed to extend this ongoing study to additional countries within and outside Europe.

The scope of the new master collaboration agreement enables collaborative development and commercialization projects between Biocartis and AstraZeneca, such as but not limited to, companion diagnostic development projects that may cover any type of indication or biomarker. The first project to be initiated under the new agreement is a study focused on evaluating if liquid biopsy testing using the Idylla™ ctEGFR Mutation Assay (RUO²) could provide further benefits to tissue-based EGFR molecular testing.

EGFR mutations are important biomarkers to be studied in Non-Small Cell Lung Cancer (NSCLC). AstraZeneca is marketing Tagrisso^® (osimertinib) which is a leading lung cancer therapy approved for patients with metastatic NSCLC whose tumors have EGFR mutations. EGFR mutations occur in 10-15% of all NSCLC patients in the US and the EU and in 30-40% of all NSCLC patients in Asia³. The Idylla™ ctEGFR Mutation Assay (RUO²), launched in October 2019, is a liquid biopsy assay which allows the detection of 49 EGFR mutations directly from 2 ml of blood plasma and provides results within approximately 160 minutes.

Herman Verrelst, Chief Executive Officer of Biocartis, commented: “We are very pleased to announce today that we are further developing our partnership with AstraZeneca by entering into a master collaboration agreement, with a first project focused on our newly launched liquid biopsy Idylla™ ctEGFR Mutation Assay². Current EGFR molecular diagnostic testing is complex because obtaining high quality tissue samples is difficult, especially in NSCLC where tumors are often very small, leading often up to several weeks of waiting time⁴ before results are available. Liquid biopsy EGFR testing with the Idylla™ ctEGFR Mutation Assay², operating directly from 2 ml of blood plasma, could overcome these challenges and delivers molecular EGFR mutation information faster and easier.”