Microsatellite Instability (MSI), Tumor

72 Hours

Real-time PCR – Biocartis Idylla™

Rejection Criteria:

Tumor Cell Content Samples with tumor content below the minimum validated threshold (<20%).

Improper Fixation or Processing (for tissue samples) Tissue fixed in inappropriate fixatives or with poor fixation compromising nucleic acid quality.

Insufficient Sample Material Insufficient tissue area, exhausted blocks/slides, or samples with inadequate material for testing.

Sample Integrity Issues Samples that are damaged, contaminated, improperly labelled, or otherwise unsuitable for analysis.

Accredited NRL Laboratory

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This CE-IVD–marked assay runs on the Biocartis Idylla™ Platform for in vitro diagnostic use. It uses formalin-fixed, paraffin-embedded (FFPE) tumor tissue to deliver rapid, automated MSI assessment via PCR-based detection of seven monomorphic biomarkers, with no paired normal tissue required. The complete workflow — from sample preparation to result generation — runs on a single platform, minimizing hands-on time with faster reporting of results.

Formalin-Fixed Paraffin-Embedded tissue block (preferred) or 2 scrolls or 5 unstained slides in a sterile container (5 μm sections), along with an H&E-stained slide for tumor cell content assessment.

Formalin-Fixed Paraffin-Embedded tissue block or 2 scrolls or 5 unstained slides in a sterile container (5 μm sections), along with an H&E-stained slide

Ambient for FFPE tissue and slides

Clinical Indication: Colorectal carcinoma and other solid tumors where MSI status is clinically indicated for tumor characterization, Lynch syndrome screening workup, prognosis, and/or immunotherapy assessment.