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For in vitro diagnostic use. For use on the Biocartis Idylla™ System only. The Idylla™ MSI Test, for use on the Idylla™ System, uses formalin-fixed, paraffin-embedded (FFPE) tissue sections of human CRC tumor, from which nucleic acids are liberated, then analyzed using PCR amplification of seven monomorphic biomarkers (ACVR2A, BTBD7, DID01, MRE11, RYR3, SEC31A and SULF2) and subsequent melt-curve analysis. The Idylla™MSI Test reports results as either microsatellite stable (MSS), or microsatellite instability high (MSI-H) or invalid. Idylla™ MSI Test is indicated for use by healthcare professionals for the qualitative identification of microsatellite instability (MSI) in colorectal cancer (CRC) tumors, indicative of mismatch repair deficiency, as an and in the identification of potential Lynch syndrome to help identify patients that would benefit from additional genetic testing to diagnose Lynch syndrome. The results from the Idylla™ MSI Test should be interpreted by healthcare professionals in conjunction with other clinical findings, family history, and other laboratory data. The Idyla™ MSI Test should not be used for diagnosis of CRC. The clinical performance of this device to guide treatment decision for MSI high patients has not been established.

The Biocartis Idylla™ System covers the entire process from sample to result with fully integrated sample preparation followed by PCR amplification and high-resolution melting detection of the targeted sequences. The Idylla™ System consists of the Idylla™ Console connected to one or more Idylla™ Instruments (up to eight instruments). Idylla™ Cartridges, designed for specific applications, can be processed by the Idylla System using test specific software (Test Type Package, MSI TTP). The Idylla™ MSI Test procedure and data analysis are validated for FFPE tissue sections. The Idylla™ MSI Test detects a novel panel of seven monomorphic biomarkers. The Idylla™ MSI Test Cartridges are ready-for-use and contain the necessary reagents to perform sample preparation, PCR amplification and high-resolution detection, starting from insertion of FFPE tissue sections. The MSI TTP directs the processing of the sample within the cartridge. The process steps in the Idylla™ MSI Test are: - FFPE liquefaction and cell lysis: After insertion of the FFPE tissue section into the cartridge, a combination of chemical reagents, enzymes, heat, and High Frequency Ultrasound (HIFU) induces deparaffinization, disruption of the tissue and lysis of the cells. The nucleic acids are liberated for subsequent PCR amplification. - PCR using biomarker-specific primers: All necessary PCR reagents are present in a stable formulation and are used to amplify seven biomarkers indicative for MSI status. - Detection and analysis: Detection of these specific targets is performed using fluorescently labeled molecular beacons after PCR amplification. These beacons differentially melt from the wild type or mutated amplicons with increasing temperature. The fluorescence differences at melting temperatures are further analyzed by the MSI TTP and translated into genetic calls on biomarker level and MSI status on sample level. - Reporting: At the end of the run, the result, reporting the MSI status, the number of mutated biomarkers, and an MSI score range in the analyzed sample is displayed on the console screen.