Press release Biocartis Group NV: Idylla ™ de Biocartis

PRESS RELEASE: December 9, 2021, 07:00 CET

Biocartis Idylla ™ SARS-CoV-2 test Successfully detects Omicron variant

Mechelen, Belgium, 9 December 2021 – Biocartis Group NV (the “Company” or “Biocartis”), an innovative molecular diagnostics company (Euronext Brussels: BCART), today announces that the Company has performed an in-silico analysis which concluded that the Idylla ™ test SARS-CoV-2 (CE-IVD) and Idylla ™ SARS-CoV-2 / Flu / RSV1 The panel (CE-IVD) detects the currently available B.1.1.529 / Omicron sequences, the worrying new variant causing COVID-19 disease.

The Idylla ™ SARS-CoV-2 assay and the Idylla ™ SARS-CoV-2 / Flu / RSV panel have dual target technology built into the assay, which increases resilience against mutations like those found in Omicron.

The Idylla ™ SARS-CoV-2 test is an automated rRT-PCR2 test for the qualitative detection of SARS-CoV-2 RNA in nasopharyngeal swab specimens from individuals suspected of COVID-19 by their health care provider. The Idylla ™ SARS-CoV-2 / Flu / RSV Panel is a fully automated rRT-PCR assay for the detection of SARS-CoV-2, Flu A, Flu B and RSV nucleic acids in nasopharyngeal swab samples from individuals suspected of having respiratory problems. infections by their health care provider. Both tests have results available in 90 minutes with less than 2 minutes of working time3.

Biocartis regularly performs in-silico analyzes for current and emerging strains. You can find more information about the Idylla ™ SARS-CoV-2 test solutions on the Biocartis website here.

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More information:
Renate degrave
Head of Corporate Communication & Investor Relations Biocartis
e-mail rdegrave@biocartis.com
phone +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 real-time Polymerase Chain Reaction (PCR) system that delivers precise and highly reliable molecular information from virtually any biological sample in virtually any environment. Biocartis develops and markets an ever-expanding menu of tests addressing key unmet clinical needs, with a focus on oncology, which represents the fastest growing MDx market segment in the world. Today, Biocartis offers tests for melanoma, colorectal cancer and lung cancer, as well as for COVID-19, influenza, RSV and sepsis. More information: www.biocartis.com. Follow us on Twitter: @Biocartis_.

Biocartis and Idylla ™ are trademarks registered in Europe, United States States and other countries. The Biocartis and Idylla ™ brand and logo are used trademarks belonging to Biocartis. Please refer to the product labeling for applicable intended uses for each individual Biocartis product. The Idylla ™ SARS-CoV-2 Products contains SuperScript™ III reverse transcriptase and are provided under license under patents or patent applications owned by or licensed to Life Technologies Corporation, which license is limited to the field of human diagnostics and research and specifically excludes forensic applications ( including human identity testing). The SuperScriptThe ™ III mark is the property of Life Technologies Corporation.

This press release is not intended for distribution, directly or indirectly, in any jurisdiction where it would be illegal. Anyone reading this press release should be aware of and obey these restrictions. Biocartis declines all responsibility in the event of violation of such restrictions by any person. This press release does not constitute an offer or an invitation to sell or buy any securities in any jurisdiction. No security 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 US Securities Act of 1933, as amended.

Forward-looking statements
Certain statements, beliefs and opinions contained in this press release are forward-looking and reflect the current expectations and projections of the Company or, where applicable, of the directors or management of the Company regarding future events such as operating results. of the Company, its financial situation, liquidity, performance, outlook, 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 forward-looking statements. These risks, uncertainties, hypotheses and the factors could affect the the results and financial effects of the plans and events described in this document. A multitude of factors including, but not limited to changes in demand, competetion and technology, can cause actual events, performance or results to differ materially 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 the actual results or developments are consistent with the forward-looking statements contained in this press release, these results or developments may not be indicative of results or developments in future periods. No representation or warranty is made as to the accuracy or fairness of these forward-looking statements. Accordingly, the Company expressly disclaims any obligation or commitment to publish any update or revision to any forward-looking statement contained 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 as specifically required by law or regulation. Neither the Company, nor its advisers or representatives, nor any of its subsidiaries or its officers or employees guarantees that the assumptions underlying these forward-looking statements are free from errors and accepts no responsibility as to the future accuracy of the statements. forward-looking statements. statements contained in this press release or the actual occurrence of anticipated developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.


1 Respiratory syncytial virus
2 Polymerase chain reaction and reverse transcription in real time
3 For the Idylla ™ SARS-CoV-2 test, the results are obtained using 200 µl of viral transport medium (VTM). For the Idylla ™ SARS-CoV-2 / Flu / RSV panel, results are obtained using 400 µl of viral transport medium (VTM) pipetted directly into the cartridge. Both assays are performed on the Idylla ™ platform capable of performing fully automated nucleic acid assays including extraction, amplification and detection in a single use cartridge. For additional performance characteristics, please refer to the instructions for use or to the Biocartis website here and here

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