PRESS RELEASE: REGULATED INFORMATION    
26 March 2020, 07:00 CET

Biocartis Announces Co-Commercialization of the SeptiCyte® RAPID Test on Idylla™ (CE-IVD) and
Provides Update on COVID-19 Impact

Mechelen, Belgium, 26 March 2020 – Biocartis Group NV (the ‘Company’ or ‘Biocartis’), an innovative molecular diagnostics company (Euronext Brussels: BCART), today announces the expansion of its partnership with Immunexpress Pty Ltd (‘Immunexpress’), a Seattle-based molecular diagnostic company, with a co-commercialization agreement for the SeptiCyte® RAPID Test for use on Biocartis’ fully automated molecular diagnostics platform Idylla™.

The SeptiCyte® RAPID Test is a rapid, host-response1 test that distinguishes sepsis from infection negative systemic inflammation in patients suspected of sepsis and provides actionable results2 in around one hour to guide the physician to optimize patient management decisions. Recent data3 indicate that sepsis is the most frequently observed complication in COVID-194. In current COVID-19 pandemic times, hospitals and ICU’s are under enormous pressure and SeptiCyte® RAPID could be a great support in detecting sepsis early on and supporting decisions for rapid initiation of sepsis management protocols in affected patients.

Biocartis and Immunexpress are strengthening their existing partnership5 with a co-commercialization agreement in which Biocartis will lead commercialization in Europe as the exclusive distributor of the  SeptiCyte® RAPID Test, while Immunexpress will lead commercialization of the SeptiCyte® RAPID Test in the US. Immunexpress also announced today that the SeptiCyte® RAPID Test for use on the Idylla™ platform received CE-marking. Immunexpress expects US FDA 510(k) clearance by Q3 2020.

Herman Verrelst, Chief Executive Officer of Biocartis, commented: “Deploying easy and rapid sepsis testing on Idylla™ with the CE-marked  SeptiCyte® RAPID Test through our direct sales force in Europe can help preventing unnecessary ICU admissions or potentially even reducing average length of hospital stays – as such reducing the pressure on the hospital system, even after the immediate crisis is addressed. Although our focus remains in oncology, we currently see high unmet needs in the field of infectious diseases that we can help address with our Idylla™ platform. The expansion of our partnership with Immunexpress also allows us to make the necessary adjustments to minimize a potential impact on our business, linked to the disruptions in our commercial operations and the uncertainties caused in the market by the COVID-19 pandemic.”

Rolland D. Carlson, Ph.D., Chief Executive Officer of Immunexpress, reacted: “I believe Biocartis, with its well established and growing Idylla™ customer base will be highly effective in delivering to the European community a new and novel sepsis diagnostic tool, designed to enhance the certainty of early and rapid sepsis diagnosis, to improve clinical outcomes and to lower healthcare costs. Together, we are committed to mitigating the constraints on hospitals that are affected by the COVID‑19 pandemic, by more accurate diagnostic testing of sepsis, which is expected to enable physicians to make rapid clinical decisions in resource-constrained ICUs.”

In the context of the COVID-19 pandemic, Biocartis expects that the current prolonged measures taken in many countries across the globe to contain the spreading of COVID-19 may potentially impact the FY2020 outlook of the Company as announced in the FY19 results and 2020 outlook published on 5 March 2020, which initially assumed a normalization of activities around the April 2020 timeframe. The Company is monitoring the situation closely and will provide more information in due course. The Biocartis Q1 2020 Business Update is scheduled for 23 April 2020.

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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 in oncology. This 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.

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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 Host-response based tests focus on measuring biomarkers that are indicative of the response of a patient’s immunesystem to an infection rather that measuring pathogens that are the cause of the infection

2 Moreover, SeptiCyte® RAPID not only discriminates sepsis from SIRS (Systemic inflammatory response syndrome) but also correlates with viral sepsis infection, versus procalcitonin (PCT) which increases with severity of bacterial but not viral infection and is also a non-specific marker of inflammation

3 Zhou et al., Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study, published online 9 March 2020, https://doi.org/10.1016/S0140-6736(20)30566-3

4 Sepsis developed at a median of 9 days (7–13) after illness onset among all patients, followed by ARDS (12 days [8–15]), acute cardiac injury (15 days [10–17]), acute kidney injury (15 days [13–19.5]), and secondary infection (17 days [13–9])

5 On 24 January 2018, Biocartis and Immunexpress announced a partnership aimed at partnership aimed at the development and commercialization of Immunexpress’ SeptiCypte™ test for use on Biocartis’ sample- to-result Idylla™ platform. Source: https://investors.biocartis.com/sites/default/files/press-releases/2019/180123-Press-release-partnership-IXP_EN.pdf