Press release Biocartis Group SA: Biocartis announces a new

PRESS RELEASE: June 22, 2022, 07:00 CEST

Biocartis announces New OK with AstraZeneca for the Development and Marketing of a Companion diagnosis Test for Tagrisso®

Mechelen, Belgium, 22 June 2022 Biocartis Group NV (the “Company” or “Biocartis”), an innovative molecular diagnostics company (Euronext Brussels: BCART), announced today that it has entered into an agreement with AstraZeneca (LSE/STO/Nasdaq: AZN) to develop and applicable premarket notification or US FDA approval of a new companion diagnostic1 (CDx) on Biocartis’ Idylla™ platform for rapid and easy-to-use molecular diagnostics, for use with Tagrisso® (osimertinib), AstraZeneca’s third-generation EGFR-TKI (tyrosine kinase inhibitor) treatment.

Under the terms of the agreement, Biocartis and AstraZeneca will co-lead the development and applicable premarket notification or approval of the Idylla™ EGFR CDx test to help identify patients with breast cancer. non-small cell lung (NSCLC) likely to respond to treatment with Tagrisso®. In addition to the FFPE2 tissue, Biocartis will seek to validate the use of less invasive cytology samples such as fine needle aspirates3 for use with the Idylla™ EGFR CDx test, to expand patient access to testing.

The new project extends the existing collaboration framework agreement announced in January 2020 between Biocartis and AstraZeneca4, aiming to improve access to faster molecular diagnostic biomarker results with fast and easy-to-use Idylla™ EGFR test products. The collaboration was supported by the large prospective FACILITATE study in lung cancer, co-sponsored by AstraZeneca. This study concluded that the Idylla™ EGFR test can add value in a clinical setting to generate actionable EGFR mutation results for NSCLC patients faster than commonly used methods. In this regard, the recently signed agreement includes the experimental use of the Idylla™ EGFR CDx test to enroll patients in clinical trials at AstraZeneca.

AstraZeneca markets Tagrisso®, a leading lung cancer treatment approved for patients with resectable, locally advanced or metastatic NSCLC whose tumors have EGFR mutations. EGFR activating mutations are important biomarkers in NSCLC, occurring in 10-15% of all NSCLC patients in the US and EU, and in 30-40% of all NSCLC patients in Asia5.

Herman Verrelst, CEO of Biocartis, said: We are delighted to movement our collaboration with AstraZeneca to the next level with the development of a companion diagnostic test on Idylla™ that may enable faster and wider patient access to AstraZeneca Tagrisso® treatment. VScurrent EGFR molecular diagnostic tests remains a real challenge in clinical practice. Obtaining high quality tissue samples is difficult and complex, especially in NSCLC where tumors are often very small, often leading to several weeks of waiting before the results are availableas opposed to what we can offer with Idylla™ technology.

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More information:
Renate Degrave
Corporate Communication & Investor Relations Manager Biocartis
email [email protected]
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 real-time PCR (Polymerase Chain Reaction) system that delivers accurate and highly reliable molecular information from virtually any biological sample in virtually any environment. Biocartis develops and markets an ever-expanding menu of tests addressing key unmet clinical needs, with a focus on oncology, which represents the fastest growing segment of the MDx market globally. Today, Biocartis offers tests supporting melanoma, colorectal and lung cancer, as well as COVID-19, influenza, RSV and sepsis. More information: www.biocartis.com. Follow us on Twitter: @Biocartis_.

Biocartis and Idylla™ are registered trademarks in Europe, USA and other countries. The Biocartis and Idylla™ trademark and logo are used trademarks belonging to Biocartis. Please refer to the product labeling for the applicable intended uses for each individual Biocartis product.
This press release is not intended for distribution, directly or indirectly, in any jurisdiction where it would be illegal. Anyone reading this press release should inform themselves about and observe these restrictions. Biocartis assumes no responsibility for any violation of these restrictions by anyone. This press release does not constitute an offer or invitation to sell or buy 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 United States Securities Act of 1933, as amended.

Forward-looking statements
Certain statements, beliefs and opinions contained in this press release are forward-looking and reflect the current expectations and projections of the Company or, as the case may be, of the directors or management of the Company regarding future events such as 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, may cause actual events, performance or results to differ materially 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 representation or warranty is made as to the accuracy or correctness of these forward-looking statements. Accordingly, the Company expressly disclaims any obligation or undertaking to issue updates or revisions to any forward-looking statements contained in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which such forward-looking statements are based, except as specifically required by law or regulation. Neither the Company, nor its advisers or representatives, nor any of its subsidiaries or the officers or employees of such persons warrant that the assumptions underlying these forward-looking statements are free from error and accept no responsibility for the future accuracy of forward-looking statements. statements contained in this press release or the actual occurrence of anticipated developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.


1 A companion diagnostic test (CDx) is a test used as a companion to a therapeutic drug that predicts whether or not a patient is likely to respond to a treatment
2 FFPE = formalin fixed, paraffin embedded
3 Made into FFPE cell blocks
4 The first expansion of the collaboration was announced in May 2021 and was supported by AstraZeneca’s large prospective FACILITATE study in lung cancer (Hummel M. et al, “FACILITATE: A Prospective Multicenter Real-World Study Studying the Utility of a Rapid and Fully Automated RT-PCR Assay vs Reference Methods (RM) for the Detection of Epidermal Growth Factor Receptor (EGFRm) Mutations in NSCLC”, ESMO Virtual Congress 2020 (September 19-21 2020), first published online September 14, 2020. The poster was presented at ESMO 2020 (European Society for Medical Oncology), poster reference 1205P
5 Source: https://www.astrazeneca.com/our-focus-areas/oncology/at-the-forefront-of-lung-cancer-treatment.html, last accessed June 10, 2022

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