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Press release Biocartis Group NV: Biocartis Announces Presentation of Three Idylla™ Studies at 32nd European Congress of Clinical Microbiology & Infectious Diseases (ECCMID)

PRESS RELEASE: 25 April 2022, 07:00 CEST

Biocartis Announces Presentation of Three Idylla™ Studies at 32nd European Congress of Clinical Microbiology & Infectious Diseases (ECCMID)

Mechelen, Belgium, 25 April 2022 – Biocartis Group NV (the ‘Company’ or ‘Biocartis’), an innovative molecular diagnostics company (Euronext Brussels: BCART), today announces that three Idylla™ study posters, of which two on the SeptiCyte® RAPID (developed in collaboration with Immunexpress) and one on the Idylla™ SARS-CoV-2 Test (CE-IVD) and Idylla™ SARS-CoV-2/Flu/RSV Panel (CE-IVD), were presented at the 32nd European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) between 23 – 26 April in Lisbon, Portugal.

Herman Verrelst, Chief Executive Officer of Biocartis, commented: “We are pleased to see three study presentations on Idylla™ tests during this annual conference of Europe’s leading society in clinical microbiology and infectious diseases. The studies underline once more that the strength of Idylla™ tests lies in the combination of both fast and accurate results, enabling rapid clinical decision-making. Especially in the case of sepsis, this can save lives. Finally, these studies show how Idylla™ testing can be easily integrated within the routine diagnostic process of hospitals.”

The first study1 (abstract #04729) was presented in a poster session and evaluated whether SeptiCyte® RAPID could be used as a triage tool for COVID-19 patients at a hospital2 in France. Results demonstrated SeptiCyte® RAPID’s ability to distinguish between COVID-19 patients showing higher extents of lung damage as defined by lung CT scans (critical and severe) from those with a milder presentation (mild, moderate, absent). The SeptiScore®, as evaluated by SeptiCyte® RAPID, of critical and severe patients in the ICU was higher relative to the moderate and mild cases not in ICU. Also, the utility of the SeptiScore® for longitudinal monitoring of patients with severe cases was suggested by repeat testing on selected patients.

Rollie Carlson, Ph.D., Chief Executive Officer of Immunexpress, added: “During the COVID-19 pandemic, sepsis incidence increased. This study shows that the SeptiCyte® RAPID on the Idylla™ platform can distinguish COVID-19 cases with severe or critical presentation on a CT scan from those with mild or moderate presentation. This is essential to identify and triage patients in need of timely sepsis specific medical care.”

The second study3 (abstract #04693) was presented in an online poster session and evaluated the performance of SeptiCyte® RAPID as an everyday tool in the management of ICU patients at two clinical sites in Portugal4. Results demonstrated a significant correlation between the diagnosis of sepsis and an elevated SeptiScore®. From eight patients diagnosed with either septic shock or sepsis, six had elevated scores and two had intermediate-elevated scores. The study concluded that the SeptiCyte® score pinpointed all cases while also suggesting the diagnosis of patients of whom sepsis was not detected by most traditional methods, found to be severely lacking in this setting5.

Severe COVID-19 can be considered an example of viral sepsis. Sepsis is a life-threatening medical emergency associated with high morbidity and mortality, making early sepsis detection of utmost importance. Today’s gold standard for detecting sepsis in the laboratory setting is microbiological culture identification. However, the prediction of positive blood culture results remains a very difficult task since positive blood culture results in approx. only 20% of the cases6 due to low sensitivity. Also, it can take days to report results. Studies such as the ones presented at ECCMID show that newer methods such as the SeptiCyte® RAPID, running on Biocartis’ Idylla™ platform, combine fast and accurate results, enabling rapid clinical decision-making.

Finally, the third study7 (abstract #04963), presented in a poster session, highlighted the performance data of the Idylla™ SARS-CoV-2 Test (CE-IVD) and the Idylla™ SARS-CoV-2/Flu/RSV Panel (CE-IVD) and concluded that both Idylla™ assays provide quick, accurate results with minimal hands-on-time, making them suitable for an NHS (National Health Service, UK) setting.

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More information: Renate DegraveHead of Corporate Communications & Investor Relations Biocartise-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 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 Victor Gravrand et al., ‘SeptiCyte® RAPID in COVID-19 severity stratification and triage’, first published online during ECCMID, 23-26 April 2022, Lisbon (Portugal). The study was supported by the Biomedical Advanced Research and Development Authority (BARDA)2 94 COVID-19 positive patients were evaluated at Hospital Foch, Paris (France)3 João Antunes et al., ‘Using SeptiCyte RAPID as an everyday tool in ICU patient care management’, first published online during ECCMID, 23-26 April 2022, Lisbon (Portugal)4 The study enrolled 25 adults, 17 of whom were post-surgery and 8 of whom were COVID-19 positive. Using standard microbiological culture, presumptively causative pathogens were identified in 48.6% of cases5 Due to the design of the study and small sample cohort, further studies will be needed to finetune the positioning of SeptiCyte® RAPID6 Previsdomini M, Gini M, Cerutti B, Dolina M, Perren A. Predictors of positive blood cultures in critically ill patients: a retrospective evaluation. Croat Med J. 2012;53(1):30-39. doi:10.3325/cmj.2012.53.307 Brookes et al., Comparative study assessing the utility of a rapid based COVID-19 assay for use in a clinical diagnostic laboratory, first published online during ECCMID, 23-26 April 2022, Lisbon (Portugal). The aim was to compare the Idylla™ SARS-CoV-2 Test and the Idylla™ SARS-CoV-2/Flu/RSV Panel against the Genesig SARS-CoV-2 batch assay. The secondary aim was to assess suitability in an NHS setting