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

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.”

About Biocartis

Biocartis (Euronext Brussels: BCART) is an innovative molecular diagnostics (MDx) company providing next generation diagnostic solutions aimed at improving clinical practice for the benefit of patients, clinicians, payers and industry. Biocartis' proprietary MDx Idylla™ platform is a fully automated sample-to-result, real-time PCR (Polymerase Chain Reaction) system that offers accurate, highly reliable molecular information from virtually any biological sample in virtually any setting. Biocartis is developing and marketing a continuously expanding test menu addressing key unmet clinical needs in oncology. This area represents the fastest growing segment of the MDx market worldwide. Today, Biocartis offers tests supporting melanoma, colorectal and lung cancer. More information: www.biocartis.com. Follow us on Twitter: @Biocartis_.

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