Press news Biocartis Group NV: Biocartis Announces CE-marking of its Fully Automated Idylla™ SARS-CoV-2 Test

PRESS RELEASE: 10 November 2020, 07:00 CET

Biocartis Announces CE-marking of its Fully Automated Idylla™ SARS-CoV-2 Test

Mechelen, Belgium, 10 November 2020 – Biocartis Group NV (the ‘Company’ or ‘Biocartis’), an innovative molecular diagnostics company (Euronext Brussels: BCART), today announces to have launched the CE-marked IVD version of its fully automated Idylla™ SARS-CoV-2 Test. The test is intended to detect SARS-CoV-2, the virus that causes COVID-19, from nasopharyngeal swabs in viral transport medium, and runs on Biocartis’ rapid and easy to use molecular diagnostics platform Idylla™.

The Idylla™ SARS-CoV-2 Test is a fully automated RT-PCR¹ test intended for the qualitative detection of
SARS-CoV-2 RNA² in nasopharyngeal swab specimens from individuals suspected of COVID-19 by their healthcare provider. Results are obtained using 200 μl of viral transport media in 90 minutes, with less than 2 minutes hands-on time. The test is performed by means of a single-use Idylla™ cartridge.

Herman Verrelst, Chief Executive Officer of Biocartis, stated: “In a time where COVID-19 surges across many European countries, I am very proud of our team that worked hard to make this happen. This is our second CE-marked IVD infectious disease test offered this year on Idylla™, after the SeptiCyte^© RAPID³, which was released in Europe as a CE-IVD test early October. The Idylla™ SARS-CoV-2 Test is now available for clinical use across Europe to help healthcare providers manage this pandemic through rapid and easy testing of individuals with flu-like symptoms.”

The Idylla™ SARS-CoV-2 Test will be available across Europe, including use by Health Services Laboratories (HSL), a partnership between The Doctors Laboratory, Royal Free London NHS Foundation Trust (the Royal Free London), and University College London Hospitals NHS Foundation Trust (UCLH), one of the largest providers of highly specialized pathology and clinical laboratory services in the UK. HSL will be one of the first adopters of the Idylla™ SARS-CoV-2 Test.

Michael Gandy, Head of Research and Development for HSL, stated: “We have been pleased to add Biocartis’ Idylla™ platform to a number of other rapid diagnostic systems, with which we have undertaken performance evaluations prior to introduction in routine clinical practice. The performance characteristics of the Idylla™ SARS-CoV-2 Test have been comparable to our gold standard SARS-CoV-2 RT-PCR test offered from our central laboratory at the Halo building, London, and alongside the ease of use of the Idylla™ system, we feel this is an excellent candidate assay for provision of rapid testing in the acute setting.”

Dr. Rachael Liebmann, Group Medical Director for HSL and Vice President of the Royal College of Pathologists added: “A further major benefit is that the Idylla™ platform is already deployed across a number of UK pathology laboratories performing oncology testing within cellular pathology. Therefore, there is a potential infrastructure readily available which can be used to support the COVID-19 effort across the UK.”

The US FDA ‘Emergency Use Authorization’ for the Idylla™ SARS-CoV-2 Test is still ongoing⁴. More information on the Idylla™ SARS-CoV-2 Test can be found here on the Biocartis website.

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Renate Degrave
Head of Corporate Communications & Investor Relations Biocartis
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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 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. 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.

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.

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¹ Reverse Transcription PCR. PCR or Polymerase chain reaction is an efficient and cost-effective way to copy (amplify) small segments of DNA or RNA. As such, millions of copies of a section of DNA are made in just a few hours, allowing further analysis for clinicians to diagnose and monitor diseases using a minimal amount of sample, such as blood or tissue. Source: www.genome.gov, last consulted on 2 November 2020

² Ribonucleic Acid

³ SeptiCyte® RAPID is a host-response test that distinguishes sepsis from non-infectious systemic inflammation in patients suspected of sepsis and provides actionable results in about one hour. The test was developed by Biocartis’ partner Immunexpress Pty Ltd, a Seattle-based (US) molecular diagnostics company, and was released as part of Biocartis’ exclusive commercialization of SeptiCyte® RAPID on Idylla™ in Europe on 6 October 2020

⁴ Biocartis submitted the Idylla™ SARS-CoV-2 Test for ‘Emergency Use Authorization’ with the US FDA on 10 August 2020

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