Press Release Biocartis NV: Five Idylla™ Performance Studies to be Presented at ‘European Society for Medical Oncology’ congress

PRESS RELEASE

23 September 2019, 07:00 CEST

Mechelen, Belgium, 23 September 2019 – Biocartis Group NV (the ‘Company’ or ‘Biocartis’), an innovative molecular diagnostics company (Euronext Brussels: BCART), today announces that on the performance of Idylla™ assays will be presented at the renowned European Society for Medical Oncology (‘ESMO’) Congress taking place between 27 September - 1 October 2019 in Barcelona (Spain). In general, all studies demonstrated excellent performance of Idylla™ compared to other methods, in combination with the ease of use and fast turnaround time of the Idylla™ platform. The studies included, amongst others, the Idylla™ MSI Assay (RUO¹) and a prototype of the Idylla™ ctEFGR assay.

Of the five presented studies, four studies were performed by key opinion leaders in Europe:

• Matias-Guiu et al., ‘Microsatellite Instability Detection in Colorectal Cancer: 44-center Comparison between the Idylla™ MSI Assay and Routine Molecular and Immunohistochemistry Tests of Formalin-Fixed Paraffin-Embedded Tissue’ (University of Lleida, Spain). This is a first-time international multi-centered study across 44 centers worldwide on 1,301 archival FFPE² colorectal cancer (CRC) tissue samples, demonstrating excellent performance of the Idylla™ MSI Assay (RUO¹) compared to routine immunohistochemistry (IHC; overall concordance agreement of 96.6%) and molecular methods³ (overall concordance agreement of 98.0%). Both the molecular methods and IHC had a higher invalid rate than the Idylla™ MSI Assay⁴. Furthermore, the study concluded several other Idylla™ MSI testing advantages, such as no need for a second control tissue sample, a simple workflow, short turnaround time, automated results interpretation and very limited hands-on work.
• Rutkowski et al., ‘A Single Arm, Open Label, Phase II Multicenter Study to Assess the Detection of the BRAF V600 Mutation on cfDNA from Plasma in Patients with Advanced Melanoma’  (Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland). This was led by Roche⁵ for the treatment of BRAF mutant melanoma and supported by Biocartis.
• Bricogne et al., ‘mCRC gene profiling using the Idylla™ platform’ (University College London, London Clinical Immunology, Oncology, UK).
• Fenizia et al., ‘Tumor mutation burden and microsatellite instability in colorectal cancer’ (Centro Ricerche Oncologiche, Napoli, Italy).

The fifth presentation is a first performance ⁶ conducted by Biocartis on the prototype liquid biopsy Idylla™ ctEFGR assay and included 64 NSCLC⁷ samples. The study concluded that the prototype Idylla™ ctEGFR assay detected all mutations previously detected by the comparison method (Next-Generation Sequencing or NGS⁸). In 33 samples, NGS detected no mutation. The ctEGFR prototype assay⁹ detected seven additional mutations in this cohort¹⁰. The launch of the fully automated Idylla™ ctEGFR Mutation Assay (RUO¹) for liquid biopsy testing of EGFR mutations is expected in Q4 2019.

The abstract posters are now available for download on the ESMO website and will be published during the poster sessions at the ESMO conference (Barcelona, Spain) between 27 September - 1 October 2019. More information can be found .

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More information:

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 in oncology. This represents the fastest growing segment of the MDx market worldwide. Today, Biocartis offers tests supporting melanoma, colorectal and lung cancer. More information: . Press Photo Library available . Follow us on : @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.

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¹ RUO = Research Use Only, not for use in diagnostic procedures

² FFPE = Formalin-fixed, paraffin-embedded

³ Including the Bethesda Panel. The Bethesda MSI reference panel, established in 1997, consists of two mononucleotide loci (Big Adenine Tract or BAT-25 and BAT-26) and three dinucleotide loci (D2S123, D5S346 and D17S250). Using the Bethesda panel, cancers with instability at 2 or more of these loci were interpreted as MSI-high, and cancers with no instability at any of the five loci were considered Microsatellite Stable (MSS)

⁴ The failure rate of the Idylla™ MSI Assay was 0.23%, while the molecular methods had a higher failure rate overall of 0.86% probably due to their use of a longer amplicon. IHC had a much higher failure rate of 4.37%, possibly related to interpretation difficulties of the results. Routine method failure rates might be an underestimation as the current analysis was done retrospectively on samples with known routine results

⁵ Hoffmann-La Roche (Roche Holding AG)

⁶ Reijans et al., ‘Feasibility study of a ctEGFR prototype assay on the fully automated Idylla™ platform’ (Biocartis, Mechelen, Belgium)

⁷ Non-small cell lung cancer

⁸ Sensitivity 2-5%

⁹ The average turnaround time of a run was <2h 40 min and the hands-on time for the assay was <2 min

¹⁰ Which were confirmed after retesting with the cobas EGFR Mutation Test v2