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Press release Biocartis Group NV: Biocartis’ Idylla™ SARS-CoV-2 testing Successfully Detects Omicron Variant

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PRESS RELEASE: 9 December 2021, 07:00 CET

Biocartis Idylla™ SARS-CoV-2 testing 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 performed an in-silico analysis which concluded that the Idylla™ SARS-CoV-2 Test (CE-IVD) and the Idylla™ SARS-CoV-2/Flu/RSV1 Panel (CE-IVD) detect the currently available B.1.1.529/Omicron sequences, the new variant of concern causing COVID-19 disease.

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

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

Biocartis is performing regular in-silico analysis for current and emerging strains. More info on the Idylla™ SARS-CoV-2 testing solutions can be found on the Biocartis website here.

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More information:
Renate Degrave
Head of Corporate Communications & Investor Relations Biocartis
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: 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. The Idylla™ SARS-CoV-2 products contains SuperScript™ III Reverse Transcriptase and are provided subject to a license under patents or patent applications owned by or licensed to Life Technologies Corporation, which license is limited to the human diagnostic field and research field and specifically excludes applications in forensics (including human identity testing). The SuperScript™ III trademark is owned by Life Technologies Corporation.

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.

1 Respiratory Syncytial Virus
2 Real-Time Reverse Transcription-Polymerase Chain Reaction
3 For the Idylla™ SARS-CoV-2 Test, results are obtained using 200 μl of viral transport media (VTM). For the Idylla™ SARS-CoV-2/Flu/RSV Panel, results are obtained using 400 μl of viral transport media (VTM) pipetted directly into the cartridge. Both tests are performed on the Idylla™ platform capable of fully automated nucleic acid testing including extraction, amplification, and detection in a single-use cartridge. For additional performance characteristics, please refer to the Instructions for Use or the Biocartis website here and here

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