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
Contact Technical Support
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.
| Temperature | Period |
|---|---|
| Room Temperature | FFPE tissue and slides |
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
Contact Technical Support
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.
| Temperature | Period |
|---|---|
| Room Temperature | FFPE tissue and slides |