PRESS RELEASE:  22 January 2020, 07:00 CET

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.”

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More information:

Renate Degrave

Head of Corporate Communications & Investor Relations Biocartis

e-mail   rdegrave@biocartis.com

tel         +32 15 631 729

mobile   +32 471 53 60 64

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_.

Biocartis and Idylla™ are registered trademarks in Europe, the United States and other countries. The Biocartis and Idylla™ trademark and logo are used trademarks owned by Biocartis. This press release is not for distribution, directly or indirectly, in any jurisdiction where to do so would be unlawful. Any persons reading this press release should inform themselves of and observe any such restrictions. Biocartis takes no responsibility for any violation of any such restrictions by any person. Please refer to the product labeling for applicable intended uses for each individual Biocartis product. This press release does not constitute an offer or invitation for the sale or purchase of securities in any jurisdiction. No securities of Biocartis may be offered or sold in the United States of America absent registration with the United States Securities and Exchange Commission or an exemption from registration under the U.S. Securities Act of 1933, as amended.

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1 Announced in a press release on 29 November 2018: “Biocartis and AstraZeneca Enter Into Agreement Aimed at Faster Lung Cancer Biomarker Results”, available on www.biocartis.com

2 Research Use Only, not for use in diagnostic procedures

3 Source: https://www.astrazeneca.com/our-focus-areas/oncology/at-the-forefront-of-lung-cancer-treatment.html, last consulted on 14 January 2020

4  Ibiayi Dagogo-Jack et al., ‘Clinical Utility of Rapid EGFR Genotyping in Advanced Lung Cancer’, JCO Precis Oncol. © 2018 by American Society of Clinical Oncology, published online on ascopubs.org/journal/po on 24 July 2018; Nafa et al (2019) Journal of Molecular Diagnostics; 21(6), Abstract #ST028