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Press news Biocartis Group NV: Biocartis Announces New Collaboration with AstraZeneca to Expand Availability of Idylla™ EGFR Biomarker Testing Among Patients with Lung Cancer

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Biocartis NV
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PRESS RELEASE: 4 May 2021, 07:00 CEST

Biocartis Announces New Collaboration with AstraZeneca to Expand Availability of Idylla™ EGFR Biomarker Testing Among Patients with Lung Cancer

Approximately half of the patients with non-small cell lung cancer have tumor mutations that could inform a more targeted treatment approach, but many are not tested

Mechelen, Belgium, 4 May 2021 – Biocartis Group NV (the ‘Company’ or ‘Biocartis’), an innovative molecular diagnostics company (Euronext Brussels: BCART) today announces to have signed a new agreement with AstraZeneca, a global science-led biopharmaceutical company (LSE/STO/Nasdaq: AZN), aimed at providing access to rapid and easy-to-use Idylla™ EGFR testing products at selected hospital sites in Biocartis’ European and global distributor markets1 to support the identification of patients with EGFR mutations.

The new project expands the existing master collaboration agreement2 between Biocartis and AstraZeneca, which was established to promote and bolster access to faster molecular diagnostic biomarker results. The project further builds on the conclusion of the large prospective lung cancer FACILITATE study3, co-sponsored by AstraZeneca and presented in September last year at the renowned ESMO Virtual Congress4. This study concluded that Idylla™ EGFR testing may add value in a clinical setting to generate actionable EGFR mutation results for non-small cell lung cancer (NSCLC) patients faster than routinely used methods5.

EGFR mutations are important biomarkers in NSCLC, occurring in 10-15% of all NSCLC patients in the US and the EU, and in 30-40% of all NSCLC patients in Asia6. The fully automated Idylla™ EGFR Mutation Test (CE-IVD) covers 51 mutations in a single cartridge using only 1 FFPE7 tissue section from metastatic NSCLC and showing a high concordance of >95% compared with reference methods8.

Commenting on the new agreement, Herman Verrelst, Chief Executive Officer of Biocartis, said: “AstraZeneca has become a trusted business partner to Biocartis and I’m very excited to see our partnership with them mature and grow. With this agreement, AstraZeneca will facilitate the onboarding of new Idylla™ users while improving access to the Idylla™ EGFR Mutation Test (CE-IVD). As such, we offer the possibility to improve biomarker identification in patients with non-small cell lung cancer and, in turn, inform tumor management boards to allow precise patient management decisions. This is important, since approximately half of the patients with non-small cell lung cancer have tumor mutations that could inform a more targeted treatment approach9, but many are not tested. Lowering barriers to testing by offering a fully automated diagnostic workflow can make a true difference in the area of lung cancer biomarker testing, which is one of our key strategic pillars in oncology.

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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, with a focus in oncology, which represents the fastest growing segment of the MDx market worldwide. Today, Biocartis offers tests supporting melanoma, colorectal and lung cancer, as well as for SARS-CoV-2 and sepsis. 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. Please refer to the product labeling for applicable intended uses for each individual Biocartis product.
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. 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.

Forward-looking statements
Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company's or, as appropriate, the Company directors' or managements' current expectations and projections concerning future events such as the Company's results of operations, financial condition, liquidity, performance, prospects, growth, strategies and the industry in which the Company operates. By their nature, forward-looking statements involve a number of risks, uncertainties, assumptions and other factors that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties, assumptions and factors could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward-looking statements contained in this press release regarding past trends or activities are not guarantees of future performance and should not be taken as a representation that such trends or activities will continue in the future. In addition, even if actual results or developments are consistent with the forward-looking statements contained in this press release, those results or developments may not be indicative of results or developments in future periods. No representations and warranties are made as to the accuracy or fairness of such forward-looking statements. As a result, the Company expressly disclaims any obligation or undertaking to release any updates or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based, except if specifically required to do so by law or regulation. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person's officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.

1 Excluding US, China and Japan
2 Announced on 22 January 2020
3 Hummel M. et al, “FACILITATE: a real-world multicentre prospective study investigating the utility of a rapid, fully automated RT-PCR assay vs reference methods (RM) for detecting epidermal growth factor receptor mutations (EGFRm) in NSCLC”, ESMO Virtual Congress 2020 (19-21 September 2020), first published online on 14 September 2020
4 ESMO = European Society for Medical Oncology. The Virtual ESMO Congress took place in September 2020
5 Poster was presented at ESMO 2020, poster reference 1205P
6 Source: https://www.astrazeneca.com/our-focus-areas/oncology/at-the-forefront-of-lung-cancer-treatment.html, last consulted on 27 April 2021
7 FFPE = formalin fixed, paraffin embedded
8 De Luca et al. Journal of Clinical Pathology 2018;71:745-750
9 Tuma, Rabiya S. PHD More Than Half of NSCLC Patients Have Actionable Mutations, Lung Cancer Consortium Reports, Oncology Times: October 25, 2011 - Volume 33 - Issue 20 - p 31-32 doi: 10.1097/01.COT.0000407712.33021.9d