Biocartis announces the launch of its CE-marked IVD Idylla™ GeneFusion rapid panel for rapid treatment decisions in lung cancer

Biocartis SA

PRESS RELEASE: June 20, 2022, 07:00 CEST

Biocartis announces the launch of his Fast THISmarked IVD Idylla™ GeneFusion Sign for Quick Treatment decisions in lung cancer

  • Idylla™ GeneFusion panel available as fast IVD Lung Cancer Test Solution with CE Mark for Laboratories, with results in 180 minutes

  • 10-20% of patients with advanced lung cancer do not receive appropriate targeted therapydue to slow rotation time many current test methods, leading to a deferred delay of treatment1

Mechelen, Belgium, 20 June 2022 Biocartis Group NV (the “Company” or “Biocartis”), an innovative molecular diagnostics company (Euronext Brussels: BCART), announces the CE marking of its fully automated system Idylla™ GeneFusion Sign (CE-IVD). The panel detects in a single cartridge ALK, ROS1, RET and METex14 jumps, a wide range of actionable targets relevant in non-small cell lung cancer (NSCLC). Designed for use in clinical laboratories, the panel provides complete test results in 180 minutes, which is significantly faster than currently available testing methods that often take days or even weeks before results are available. available.

Lung cancer remains the leading cause of cancer death, with NSCLC being the most common type of lung cancer. The survival rate has increased in recent years due to the rapidly changing landscape of NSCLC treatment. Gene fusions represent an important class of gene rearrangements and have become important in NSCLC because they are linked to responses to certain targeted therapies. Their accurate and rapid detection is essential to guide therapeutic choices, which is why tests for gene rearrangements such as gene fusions are included in the international testing guidelines of the NSCLC (including ESMO and NCCN).

However, comprehensive testing for workable gene rearrangements in NSCLC is often complex and may require different technologies.2. In order to test all necessary biomarkers, laboratories usually have to use different instruments that are often not available in their own laboratory. Using different instruments also requires having enough biopsy specimens of sufficient quality, which can be difficult to obtain, especially in patients with NSCLC.

Commenting on the launch of the Idylla™ GeneFusion SignHerman Verrelst, CEO of Biocartis, said:Jcirculation time and processing time remains a significant obstacle to molecular testing. It has been shown that 10% 20% of patients with advanced lung cancer do so not receive the appropriate targeted therapy because biomarker results are not provided in right time1. With the CE IVD marked the Idylla™ GeneFusion Panel, Laboratories will have a fast actionable and inlodge the solution at their disposal that can be seamlessly integrated into virtually any lab workflow.

The Idylla™ GeneFusion Sign consolidates traditional testing workflows into a streamlined, fully automated process that delivers reliable ALK, ROS1, RET, and METex14 jump information and delivers results in 180 minutes. Additionally, the panel only needs a limited amount of samples, which saves valuable tissue samples. The Idylla™ GeneFusion Panel demonstrated high concordance results in a clinical comparison study where ALK was compared to IHC, and ROS1, RET and METex14 jump were compared to NGS3.

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More information:
Renate Degrave
Corporate Communication & Investor Relations Manager Biocartis
E-mail [email protected]
tel +32 15 631 729
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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 real-time PCR (Polymerase Chain Reaction) system that delivers accurate 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 segment of the MDx market globally. Today, Biocartis offers tests supporting melanoma, colorectal and lung cancer, as well as COVID-19, influenza, RSV and sepsis. More information: follow us on Twitter: @Biocartis_.

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1 Final et al. Integration of rapid PCR tests as an adjunct to NGS in diagnostic pathology departments in the UK: evidence from a case series of patients with non-squamous, non-small cell lung cancer (NSCLC) with follow-up? J Clin Pathol. January 5, 2022 Chu et al. Clinical utility and performance of an ultrafast multiplex RNA-based assay for the detection of ALK, ROS1, RET and NTRK1/2/3 rearrangements and MET exon 14 skipping alterations. J Mol Diagn. April 2022
2 Ie gene fusions and METex14 jump. Techniques used to detect NTRK gene fusions include DNA-based next-generation sequencing (NGS), RNA-based NGS, reverse transcriptase PCR (RT-PCR), in situ hybridization by fluorescence (FISH) and immunohistochemistry (IHC). Source: OncologyPro, ESMO, see herelast consulted on June 2, 2022
3 Data taken from the evaluation of clinical performance carried out by Biocartis with a view to CE marking. The clinical performance evaluation compared the Idylla™ GeneFusion Panel to IHC (ventana ALK (D5F3) Assay, Roche Diagnostics GmbH) for ALK; Skipping of ROS1, RET and METex14 was assessed against NGS (Oncomine™ Focus Assay, Thermo Fisher Scientific)

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