BCART Biocartis Group NV

PRESS RELEASE: 6 October 2020, 07:00 CEST                                                                                         

Biocartis Announces Market Release of SeptiCyte® RAPID test on Idylla™

Mechelen, Belgium, 6 October 2020 – Biocartis Group NV (the ‘Company’ or ‘Biocartis’), an innovative molecular diagnostics company (Euronext Brussels: BCART), today announces the market release of SeptiCyte® RAPID on Idylla™ as a CE-marked IVD test. SeptiCyte® RAPID is a host-response test1 that distinguishes sepsis from non-infectious systemic inflammation in patients suspected of sepsis and provides actionable results in about one hour. The test was developed by Biocartis’ partner Immunexpress Pty Ltd (‘Immunexpress’), a Seattle-based (US) molecular diagnostics company, and is now being released as part of Biocartis’ exclusive commercialization2 of SeptiCyte® RAPID on Idylla™ in Europe.

Sepsis is the body’s life-threatening response to infection, which can lead to tissue damage, organ failure, and death3. A recent scientific publication by The Lancet estimated that in 2017 there were 48.9 million cases and 11 million sepsis-related deaths worldwide, which accounted for almost 20% of all global deaths4. Early and rapid diagnosis of sepsis is furthermore essential to avoid unnecessary hospital costs or overuse of antibiotics, which leads to greater antibiotic resistance among vulnerable patient populations.

Current diagnostic tests to aid in the diagnosis of sepsis are often unreliable and slow. At the virtual e-ISICEM symposium5 held between 15-18 September 2020, Immunexpress presented clinical validation data6 which demonstrated comparable and reproducible results between Immunexpress’ existing US FDA-cleared test, SeptiCyte® LAB, and SeptiCyte® RAPID on Idylla™. These data are the first validation of a rapid, fully-integrated, reproducible, immune response-based sepsis diagnostic test6.

Herman Verrelst, Chief Executive Officer of Biocartis, reacted: “Together with our partner Immunexpress, the SeptiCyte® and Idylla™ technologies joined forces in a single one-step, sample-to-result test that, thanks to the Idylla™ platform, can now be rolled out globally. As the exclusive distributor of SeptiCyte® RAPID in Europe, we are very pleased to offer this test to our existing and new customer base within our well-established European laboratory and hospital network. I believe we can make a real difference with this test that now allows7 to detect the likelihood of sepsis early on and provides actionable results to clinicians in approximately one hour for critically-ill patients suspected of sepsis, where every second counts."

SeptiCyte® RAPID on Idylla™ as CE-marked IVD test is now available8 for ordering. More info can be found on the Biocartis website.

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More information: Renate DegraveHead of Corporate Communications & Investor Relations Biocartise-mail   rdegrave@biocartis.comtel         +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. 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.

Forward-looking statementsCertain 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 By testing whole blood directly, the assay is able to detect the response of the patient’s immune system to an infection earlier, faster and more accurately than finding the pathogen

2 As announced on 26 March 2020

3 Source: https://www.sepsis.org/, last consulted on 24 September 2020

4 Rudd KE, Johnson SC, Agesa KM, Shackelford KA, Tsoi D, Kievlan DR, et al. Global, regional, and national sepsis incidence and mortality, 1990-2017: analysis for the Global Burden of Disease Study. Lancet (London, England). 2020;395(10219):200-11

5 International Symposium on Intensive Care and Emergency Medicine

6 Source: Immunexpress website and on https://www.prnewswire.com/news-releases/immunexpress-presents-data-on-clinical-validation-of-septicyte-rapid-for-diagnosing-sepsis-at-e-isicem-301130702.html, last consulted on 24 September 2020

7 Used in conjunction with clinical assessments, vital signs and laboratory findings

8 Available to select countries within the EU and European region. Check availability with your local Biocartis representative

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