New Study Led by Memorial

PRESS RELEASE: 4 May 2022, 07:00 CEST

New Study Led by Memorial Sloan Kettering Cancer Center (NY, US) Shows Idylla™ GeneFusion Assay Enables More Rapid Screening of
Targetable Fusions Compared to Routine Methods

• Therapeutically actionable gene fusions drive approximately 10% of non-small-cell lung cancers¹
• Current molecular methods including Next Generation Sequencing (NGS) are complex with long turnaround times
• Study² demonstrates the Idylla™ GeneFusion Assay (RUO³) enables more rapid screening of targetable fusions compared to routine methods

Mechelen, Belgium, 4 May 2022 – Biocartis Group NV (the ‘Company’ or ‘Biocartis’), an innovative molecular diagnostics company (Euronext Brussels: BCART), today announces the publication of a new study in the Journal of Molecular Diagnostics on the Idylla™ GeneFusion Assay (RUO) for rapid detection of targetable fusions involving ALK, ROS1, RET, and NTRK1/2/3 and MET exon 14 skipping mutations. The study concluded: “The assay enables rapid screening for clinically actionable kinase alterations with quicker turnaround and lower tissue requirements compared to immunohistochemistry and molecular methods, while also circumventing the infrastructure dependencies associated with Next Generation Sequencing (NGS) and fluorescence in situ hybridization”. The study was performed by Memorial Sloan Kettering Cancer Center (NY, US), one of the largest private cancer centers in the world.

Herman Verrelst, Chief Executive Officer of Biocartis, commented: “This study shows the Idylla™ GeneFusion Assay’s added value when rapid testing is needed, and highlights other benefits including the Assay’s low tissue requirements that still allow for further NGS testing in negative cases, and perhaps most importantly, the results are delivered in three hours due to the fully automated nature of the Assay, where other methods today often take several days to weeks.”

Therapeutically actionable gene fusions drive approximately 10% of non-small-cell lung cancers¹ (NSCLC). Up to 40% of rearrangement-driven lung cancers are diagnosed at an advanced stage (III to IV)⁴, however tyrosine kinase inhibitor therapy typically induces rapid and profound clinical improvement⁵. As such, timely recognition of these alterations is critical in the clinic. Current methods to detect kinase fusions such as fluorescence in situ hybridization (FISH) or NGS can be complex to perform, require a large lab infrastructure, have long turnaround times and can be cumbersome when it comes to interpretation of the data. Although NGS has become the mainstay for high throughput therapeutic target search, most NGS assays have high tissue requirements, need turnaround times of 2 to 3 weeks and bring about underlying genomic and biologic complexities that can lead to false-negative gene fusion results.

The study analyzed 143 independent FFPE⁶ tumor samples. The study stated that “testing was successful in 142 (99%) cases”. Furthermore, the study stated that “the Idylla™ GeneFusion Assay demonstrated a sensitivity of 97% (28/29), 100% (31/31), 92% (22/24), 81% (22/27), and 100% (20/20) for ALK, RET, ROS1, and NTRK1/2/3 rearrangements and MET exon 14 skipping alterations, respectively, with 100% specificity for all.”

The fully automated Idylla™ GeneFusion Assay (RUO) detects ALK, ROS1, RET, NTRK1/2/3 rearrangements and MET exon 14 skipping in a single cartridge, with less than 2 minutes hands-on time and results available in approx. 180 minutes.

The CE-IVD version of the Idylla™ GeneFusion Panel is planned for end of H1 2022.

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More information:

Renate Degrave
Head of Corporate Communications & Investor Relations Biocartis
e-mail        rdegrave@biocartis.com
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: www.biocartis.com. Follow us on Twitter: @Biocartis_.

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1 Lee SE, et al., ‘Comprehensive analysis of RET and ROS1 rearrangement in lung adenocarcinoma’, Mod Pathol 2015, 28:468e479; and Pan Y et al., : ‘ALK, ROS1 and RET fusions in 1139 lung adenocarcinomas: a comprehensive study of common and fusion pattern-specific clinicopathologic, histologic and cytologic features’, Lung Cancer 2014, 84:121e126
2 M. Arcila et al., ‘Clinical Utility and Performance of an Ultrarapid Multiplex RNA-Based Assay for Detection of ALK, ROS1, RET, and NTRK1/2/3 Rearrangements and MET Exon 14 Skipping Alterations’, Published 14 April 2022, DOI: https://www.jmdjournal.org/article/S1525-1578(22)00080-0/fulltext
3 Research Use Only, not for use in diagnostic procedures
4 Kim H et al., ‘A comprehensive comparative analysis of the histomorphological features of ALK-rearranged lung adenocarcinoma based on driver oncogene mutations: frequent expression of epithelial-mesenchymal transition markers than other genotype’, PLoS One 2013, 8:e76999
5 Kitazawa S, et al., ‘Successful use of extracorporeal membrane oxygenation for airway-obstructing lung adenocarcinoma’, Thorac Cancer 2020, 11:3024e3028
6 Formalin Fixed, Paraffin Embedded