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Press release Biocartis Group NV: New Study Demonstrates Idylla™ EGFR Mutation Test (CE-IVD) Shortens Time to Patient Management Decisions for Patients with Non-Small Cell Lung Cancer

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PRESS RELEASE: 16 November 2021, 07:00 CET

New Study Demonstrates Idylla™ EGFR Mutation Test (CE-IVD) Shortens Time
to
Patient Management Decisions for Patients with Non-Small Cell Lung Cancer

Mechelen, Belgium, 16 November 2021 – Biocartis Group NV (the ‘Company’ or ‘Biocartis’), an innovative molecular diagnostics company (Euronext Brussels: BCART), today announces the publication of a new study1 that demonstrates that the Idylla™ EGFR Mutation Test (CE-IVD) running on Biocartis’ molecular diagnostics Idylla™ platform improves patient management decisions for patients with non-small cell lung cancer (NSCLC) through the faster screening of EGFR mutations.

Nearly 85% of lung cancers are non-small cell lung cancers2. EGFR or ‘Epidermal Growth Factor Receptor’ mutations are the second most common cancer driver mutation in NSCLC. EGFR testing is important for the detection of EGFR mutations which helps to determine whether someone with NSCLC may benefit from targeted therapy-based regimens in case of presence of EGFR mutations, or potentially from immunotherapy-based regimens in case of absence of EGFR mutations3. EGFR mutations are commonly assessed by using Next-Generation Sequencing (NGS). This is a more complex and time-consuming technology, leading to an average expected time-to-result of approx. 15 days, which delays informed patient management decisions for patients with NSCLC.

The Idylla™ EGFR Mutation Test is a fully automated test using a slice of formalin-fixed, paraffin embedded (FFPE) tissue material as sample input, requiring less than 2 minutes hands-on-time and generating results in about 150 minutes. Previous studies4 have already reported excellent concordance between the Idylla™ EGFR Mutation Test and other routine EGFR testing methods, including NGS. This new study however specifically investigated if the faster time-to-result of the Idylla™ EGFR Mutation Test could shorten the time to patient management decisions for patients with NSCLC, as compared to NGS.

The study compared EGFR mutations analysis between the Idylla™ platform using the Idylla™ EGFR Mutation Test, and NGS in 223 patients with NSCLC. Idylla™ demonstrated 96.4% overall agreement with NGS and did not generate any false positive results5. On average, EGFR results using Idylla™ became available 12.6 calendar days earlier compared to NGS. As a result, with Idylla™, the timeframe from tumor sampling to the initiation of treatment was 16.1 calendar days earlier compared to NGS. The study concluded that the Idylla™ platform contributes to improving patient management decisions for patients with NSCLC through the faster screening of EGFR mutations.

Herman Verrelst, Chief Executive Officer of Biocartis, commented: “This new publication clearly shows the high clinical value of our Idylla™ EGFR Mutation Test. The study demonstrates it is a sensitive and rapid solution for the detection of EGFR mutations with a significantly faster turnaround time compared to NGS. On average, with Idylla™, time to patient management decisions was shortened with two weeks compared to the use of NGS.

The study can be consulted on the website of ‘Current Oncology’ here.

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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 COVID-19, flu, RSV 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 Petiteau, C.; Robinet-Zimmermann, G.; Riot, A.; Dorbeau,M.; Richard, N.; Blanc-Fournier, C.; Bibeau, F.; Deshayes, S.; Bergot, E.; Gervais, R.; et al. Contribution of the Idylla™ System to Improving the Therapeutic Care of Patients with NSCLC through Early Screening of EGFR Mutations. Curr. Oncol. 2021, 28, 4432–4445. https://doi.org/10.3390/curroncol28060376, published 3 November 2021
2 Hutchinson, B.; Shroff, G.S.; Truong, M.T.; Ko, J.P. Spectrum of lung adenocarcinoma. Semin. Ultrasound CT MRI 2019, 40, 255–264
3 Hofman, P. EGFR Status Assessment for Better Care of Early Stage Non-Small Cell Lung Carcinoma: What Is Changing in the Daily Practice of Pathologists? Cells 2021, 10, 2157. https://doi.org/ 10.3390/cells10082157, first published on 21 Aug 2021
4 More info on www.biocartis.com/publications
5 The Idylla™ EGFR Mutation Test (CE-IVD) detected 20 of the 26 (77%) EGFR mutations that were detected using NGS. Regarding the seven missed EGFR mutations, five were not detected by design by the Idylla™ EGFR Mutation Test, one was assayed in a sample with insufficient neoplastic cell content for Idylla™, and the last was in a sample not validated by the Idylla™ EGFR Mutation Test (a bone metastasis)


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