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Press release Biocartis Group NV: Biocartis Launches Idylla™ GeneFusion Assay as Rapid Lab Workflow Solution for Gene Fusion Testing

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Biocartis NV
·8-min read
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PRESS RELEASE: 22 March 2021, 07:00 CET

Biocartis Launches Idylla™ GeneFusion Assay asRapid Lab Workflow Solution for Gene Fusion Testing

Mechelen, Belgium, 22 March 2021 – Biocartis Group NV (the ‘Company’ or ‘Biocartis’), an innovative molecular diagnostics company (Euronext Brussels: BCART), today announces the launch of the highly innovative Idylla™ GeneFusion Assay (RUO1). The Assay detects, in one single cartridge, a wide range of biomarkers covering all gene fusions considered to be relevant in cancer research. The Idylla™ GeneFusion Assay (RUO) is therefore expected to provide a much faster testing solution for laboratories, compared to other testing methods including Next-generation Sequencing (NGS) testing which often takes days or even weeks before results are available.

Gene fusions represent an important class of somatic alterations in cancer and have become important biomarkers for cancer diagnosis, prognosis and the selection of targeted therapies2. The discovery and research for further understanding of fusion genes across multiple cancer types may provide more effective therapies in the future. Over the last 20 years, many gene fusions have been discovered in hematological cancers, solid tumors and sarcomas. Current gene fusion testing techniques are complex since these require a combination of different technologies3, often only available in different laboratories, to test all needed biomarkers. This also implies the need for sufficient sample quality and quantity which is difficult to obtain, especially for certain cancers such as lung cancer.

The Idylla™ GeneFusion Assay (RUO) includes a highly multiplexed panel of biomarkers and is the first FFPE4 RNA5-based assay on the Idylla™ platform. The Assay consolidates traditional testing workflows into one fully automated process providing objective information on ALK, ROS1, RET, NTRK1/2/3 fusions and MET exon 14 skipping, all in one cartridge, directly from 1-3 slices of FFPE tissue. Results are available within approx. 3 hours, with less than 2 minutes hands-on time. Preliminary data6 comparing the Idylla™ GeneFusion Assay (RUO) with today’s frequently used technologies such as Immunohistochemistry, FISH or NGS, show excellent results of the Assay, with concordance up to 100%.

Commenting on the launch of the Idylla™ GeneFusion Assay, Herman Verrelst, Chief Executive Officer of Biocartis, said: “This Assay is long-awaited by many of our lab-customers who, from now on, will be able to test gene fusions in a very fast and simple manner. Thanks to a unique combination of two detection technologies, the Idylla™ GeneFusion Assay (RUO) contains all relevant gene fusion biomarkers in one single cartridge, allowing labs to rapidly integrate gene fusion testing in their workflows. The benefits of this Assay not only include its speed and simplicity, but it also requires limited sample input thereby saving valuable tissue specimens. This is often an issue in areas such as biomarker testing performed on lung tissue. With the addition of the Idylla™ GeneFusion Assay (RUO) to our test menu, we can from now on offer our lab-customers a comprehensive testing solution for molecular biomarkers in this area, without the need for different instruments, and covering the majority of recognized gene fusion biomarkers.”

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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 SARS-CoV-2 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.
Patents US 7,700,339, 8,168,383, 8,481,279, 8,486,645, 8,232,060, 8,288,102, 8,377,642, 9,988,688, 9,523,130, 9,096,855, 10,526,661, 9,364,477, 9,539,254, 10,551,383 and pending US applications and all their respective foreign equivalents under license from Cell Signaling Technology, Inc. This product contains SuperScript™ III Reverse Transcriptase and is 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 RUO = Research Use Only. The Idylla™ GeneFusion Assay is for Research Use Only, not for use in diagnostic procedures

2 Stransky et al. The landscape of kinase fusions in cancer. Nat Commun. 5, 4846, 2014; Mertens et al. The emerging complexity of gene fusions in cancer. Nat Rev Cancer 15, 371-381, 2015

3 Techniques used to detect NTRK gene fusions include DNA-based next-generation sequencing (NGS), RNA-based NGS, reverse-transcriptase PCR (RT-PCR), fluorescence in situ hybridisation (FISH), and immunohistochemistry (IHC). Source: OncologyPro, ESMO, see here, last consulted on 15 March 2021

4 Formalin fixed, paraffin embedded

5 Ribonucleic Acid. RNA is one of the three major biological macromolecules that are essential for all known forms of life (along with DNA and proteins)

6 The concordance study was performed on NSCLC (non-small cell lung cancer) and thyroid cancer samples with prototype cartridges but re-analyzed with final Idylla™ GeneFusion Assay (RUO) decision tree. Moreover, the Idylla™ GeneFusion Assay was able to generate accurate results in 29/32 inconclusive IHC and FISH results. Preliminary data can be found on