Mechelen, Belgium – Biocartis Group NV (the ‘Company’ or ‘Biocartis’), an innovative molecular diagnostics company (Euronext Brussels: BCART), today announces that five study posters 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:
The fifth presentation is a first performance study6 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 here 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 here.
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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: www.biocartis.com. Follow us on Twitter: @Biocartis_.
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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