Press release Biocartis Group NV: Biocartis Announces Restart of its High-Throughput Cartridge Manufacturing Line

PRESS RELEASE: 23 September 2021, 07:00 CEST

Biocartis Announces Restart of its High-Throughput Cartridge Manufacturing Line

Mechelen, Belgium, 23 September 2021 – Biocartis Group NV (the ‘Company’ or ‘Biocartis’), an innovative molecular diagnostics company (Euronext Brussels: BCART), today announces the restart of its high-throughput ‘ML2’ cartridge manufacturing line.

Following a that broke out at one of the Company’s warehouse facilities in Mechelen (Belgium) during the night of 30 July 2021, production at the ML2 line was temporarily suspended due to the need for structural repairs to the building and select supporting systems. Those repairs, as well as several subsequent control and quality related procedures, were completed earlier this week. This led to the successful restart of the ML2 line in the night of 21 September 2021.

Herman Verrelst, Chief Executive Officer of Biocartis, reacted: “I am very pleased to announce that as from today, commercial cartridge production on the ML2 line has resumed. Our teams have worked tremendously hard to get the ML2 line up and running again after the fire incident. We can be proud of this accomplishment which shows the strength and resilience of our teams.”

Earlier this month, on 2 September 2021 at the announcement of its H1 2021 results, Biocartis had confirmed its 40% cartridge volume growth target for 2021, however subject to the restart of the ML2 line and to the timely availability of reagent raw materials for Idylla™ cartridges in sufficient quantities. With the ML2 line now restarted, the Company is continuing efforts to secure the supply of certain assay-specific reagents, to be able to utilize the full capacity of the ML2 line and to minimize potential temporary unavailability of certain Idylla™ products.

--- END ---

More information:

Renate Degrave

Head of Corporate Communications & Investor Relations Biocartis

e-mail        

tel             

mobile          4

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 SARS-CoV-2/flu/RSV and sepsis. More information: . Follow us on : @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.