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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.

The BOND MMR Antibody Panel is intended to be used for the qualitative identification by light microscopy of human mismatch repair (MMR) proteins MLH1, MSH2, MSH6 and PMS2 in formalin-fixed, paraffin-embedded (FFPE) colorectal cancer (CRC) tissue sections by immunohistochemical staining. The BOND MMR Antibody Panel includes BOND Ready-to-Use Primary Antibody MLH1 (Mismatch Repair Protein) (ES05), BOND Ready-to-Use Primary Antibody MSH2 (Mismatch Repair Protein) (79H11), BOND Ready-to-Use Primary Antibody MSH6 (Mismatch Repair Protein) (EP49) and BOND Ready-to-Use Primary Antibody PMS2 (Mismatch Repair Protein) (EP51). The BOND MMR Antibody Panel is intended for use on the BOND-III or BOND-MAX fully automated systems with BOND Polymer Refine Detection. The BOND MMR Antibody Panel is indicated for the detection of MMR protein deficiency as an aid in the identification of potential hereditary nonpolyposis colorectal cancer (HNPCC)/Lynch Syndrome in patients diagnosed with CRC. Patients with "MMR Loss" results should receive additional diagnostic testing consistent with clinical practice guidelines for diagnosis of Lynch syndrome. The BOND MMR Antibody Panel is not intended for use in indications other than CRC. This test should not be used for diagnosis of CRC. The clinical interpretation of any staining or its absence when using the BOND MMR Antibody Panel should be complemented by morphological studies and proper controls and should be evaluated within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist. The clinical performance of this device to guide treatment of MMR deficient patients has not been established.

The BOND MMR Antibody Panel [subject device] consists of the following BOND Ready-to-Use (RTU) Primary Antibody (PA) products: - MLH1 (Mismatch Repair Protein) (ES05) (PA0988-U) . - MSH2 (Mismatch Repair Protein) (79H11) (PA0989-U) . - . MSH6 (Mismatch Repair Protein) (EP49) (PA0990-U) - . PMS2 (Mismatch Repair Protein) (EP51) (PA0991-U) The BOND MMR Antibody Panel is intended for use on the BOND-III or BOND-MAX fully automated systems with BOND Polymer Refine Detection (DS9800). The BOND MMR Antibody Panel is indicated for the detection of mismatch repair protein deficiency as an aid in the identification of potential Hereditary Non-Polyposis Colorectal Cancer (HPNCC)/Lynch Syndrome in patients diagnosed with CRC. MLH1 (Mismatch Repair Protein) (ES05) is a mouse anti-human monoclonal antibody produced as a tissue culture supernatant, and supplied in Tris buffered saline with carrier protein, containing 0.35 % ProClin™ 950 as a preservative and in a total volume of 7 mL. The antibody is optimally diluted for use on the automated BOND-MAX or BOND-III instrument staining platforms in combination with BOND Polymer Refine Detection (DS9800). MSH2 (Mismatch Repair Protein) (79H11) is a mouse anti-human monoclonal antibody produced as a tissue culture supernatant, and supplied in Tris buffered saline with carrier protein, containing 0.35 % ProClin™ 950 as a preservative and in a total volume of 7ml. The antibody is optimally diluted for use on the automated BOND-MAX or BOND-III instrument staining platforms in combination with BOND Polymer Refine Detection (DS9800). MSH6 (Mismatch Repair Protein) (EP49) is a rabbit anti-human monoclonal antibody produced as an affinity-purified tissue culture supernatant, and supplied in Tris buffered saline with carrier protein, containing 0.35 % ProClin™ 950 as a preservative and in a total volume of 7ml. The antibody is optimally diluted for use on the automated BOND-MAX or BOND-III instrument staining platforms in combination with BOND Polymer Refine Detection (DS9800). PMS2 (Mismatch Repair Protein) (EP51) is a rabbit anti-human monoclonal antibody produced as an affinity purified tissue culture supernatant, and supplied in Tris buffered saline with carrier protein, containing 0.35 % ProClin™ 950 as a preservative and in a total volume of 7ml. The antibody is optimally diluted for use on the automated BOND-MAX or BOND-III instrument staining platforms in combination with BOND Polymer Refine Detection (DS9800). Instrument and Software: The BOND-MAX and BOND-III instruments are fully automated slide stainers that perform automated deparaffinization (dewaxing), antigen retrieval, immunohistochemistry (IHC) staining/in situ hybridization (ISH) staining, and counterstaining. The major components of the BOND staining platforms are the processing module, computer (BOND controller), handheld ID scanner, and slide label printer. The BOND staining platforms are composed of a number of discrete software components including the BOND application software, BOND instrument/processing module software, BOND service software, and Laboratory interface system - integration package (LIS-IP).

The OncoMate™ MSI Dx Analysis System is a qualitative multiplex polymerase chain reaction (PCR) test intended to detect the deletion of mononucleotides in 5 microsatellite loci (BAT-25, NR-21, NR-24 and MONO-27) using matched tumor and normal DNA obtained from formalin fixed, paraffin-embedded (FFPE) colorectal tissue sections. The OncoMate™ MSI Dx Analysis System is for use with the Applied Biosystems® 3500Dx Genetic Analyzer and OncoMate™ MSI Dx Interpretive Software. The OncoMate™ MSI Dx Analysis System is indicated in patients diagnosed with colorectal cancer (CRC) to detect microsatellite instability (MSI) as an aid in the identification of probable Lynch syndrome to help identify patients that would benefit from additional genetic testing to diagnose Lynch syndrome. Results from the OncoMate™ MSI Dx Analysis System should be interpreted by healthcare professionals in conjunction with other clinical findings, family history, and other laboratory data. The clinical performance of this device to guide treatment decision for MSI high patients has not been established.

The OncoMate™ MSI Dx Analysis System assay encompasses a complete workflow for MSI determination, from DNA extraction to data analysis. DNA is extracted from FFPE colorectal tissue samples (normal and tumor from the same patient) using the Maxwell® CSC DNA FFPE Kit and Maxwell® CSC Instrument. Double-stranded DNA (dsDNA) is then quantified using a fluorescence-based dsDNA quantification system of the user's choice. Next, amplification products are generated through multiplex PCR amplification of DNA microsatellite markers using the OncoMate™M MSI Dx Analysis System amplification kit. The PCR products are then mixed with Hi-Di™ Formamide and Size Standard 500 and heat-denatured. The resulting single-stranded DNA fragments are separated by size and detected via fluorescence using an Applied Biosystems® 3500Dx Genetic Analyzer. Following capillary electrophoresis, allele sizes from the CRC tumor DNA and the normal DNA are calculated and compared for each of the microsatellite markers using OncoMate™ MSI Dx Interpretive Software. If the length of two or more of the five mononucleotide-repeat marker alleles is changed by ≥2.75 base pairs (bp), the tumor is classified as MSI-H; if the allele length is changed for only one marker, or if the difference in allele lengths at the five markers is <2.75bp, the tumor is classified as Microsatellite Stable (MSS). The sizes of the Penta C and Penta D pentanucleotide-repeat marker alleles are compared as an identity check between the normal and tumor DNA samples.

The VENTANA MMR IHC Panel is a qualitative immunohistochemistry (IHC) test intended for use in the light microscopic assessment of mismatch repair (MMR) proteins (MLH1, PMS2, MSH2, and MSH6) and BRAF V600E proteins in formalin-fixed, paraffin-embedded colorectal cancer (CRC) tissue sections. The OptiView DAB IHC Detection Kit is used with MLH1, MSH2, MSH6 and BRAF V600E, and the OptiView DAB IHC Detection Kit with OptiView Amplification Kit is used for PMS2 detection. The VENTANA MMR IHC Panel is for use on the VENTANA BenchMark ULTRA instrument. The VENTANA MMR IHC Panel includes VENTANA anti-MLH1 (M1) Mouse Monoclonal Primary Antibody, VENTANA anti-PMS2 (A16-4) Mouse Monoclonal Primary Antibody, VENTANA anti-MSH2 (G219-1129) Mouse Monoclonal Primary Antibody, VENTANA anti-MSH6 (SP93) Rabbit Monoclonal Primary Antibody, and VENTANA anti-BRAF V600E (VE1) Mouse Monoclonal Primary Antibody. The VENTANA MMR IHC Panel is indicated in patients diagnosed with colorectal cancer (CRC) to detect mismatch repair (MMR) proteins deficiency as an aid in the identification of probable Lynch syndrome and to detect BRAFV600E protein as an aid to differentiate between sporadic CRC and probable Lynch syndrome. Results from the Ventana MMR IHC Panel should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information, and proper controls. The clinical performance of this device to guide treatment of MMR deficient patients has not been established.

The Ventana MMR IHC panel is comprised of five primary antibodies used to detect the MMR proteins MLH1, PMS2, MSH2 and MSH6 and mutated BRAF V600E protein in CRC tissue specimens. The primary antibodies are used in combination with individually optimized detection reagents and in conjunction with ancillary reagents common to all immunohistochemistry test systems in order to complete specimen testing. The MMR IHC panel and BRAF V600E are optimized to run on the VENTANA BenchMark Ultra platform with OptiView DAB detection kit or in the case of PSM2 antibody the OptiView DAB detection Kit with the OptiView Amplification Kit. The presence or absence of target proteins is determined by visual examination of the specimen slide under light microscope by a qualified pathologist. The Ventana MMR IHC panel antibodies are packaged as individual products in single ready to use reagent dispensers. The MMR IHC panel test is run on five separate CRC tissue slides and stained on BenchMark Ultra instrument.