IDYLLA™ CDx MSI TEST (CE-IVD) - COMING SOON!
A0220/6
The Idylla™ CDx MSI Test is a fully automated, sample-to-result companion diagnostic to detect MSI, setting a new benchmark in ease of use and rapid turnaround to identify mCRC patients eligible for OPDIVO® (nivolumab) in combination with YERVOY® (ipilimumab).
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It is estimated that ~ 5% of all metastatic colorectal tumors are microsatellite high (MSI-H), with immunotherapy being the recommended first-line treatment option for unresectable or metastatic MSI-H/dMMR CRC patients1.
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CheckMate-8HW2 demonstrated a 2-year PFS rate with OPDIVO® and YERVOY® vs chemotherapy of 72% vs 14% as first-line treatment for MSI-H/dMMR unresectable or metastatic CRC patients according to central MSI/MMR confirmation, including the Idylla™ CDx MSI Test.
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13% of enrolled patients in CheckMate-8HW were classified as pMMR/MSS after central testing, underscoring the importance of using companion diagnostics such as the Idylla™ CDx MSI Test to accurately identify the eligible treatment population3.
Idylla™ CDx MSI Test (A0220/6) is CE-marked in Europe in compliance with the EU IVD Regulation 2017/746 (IVDR). Idylla™ MSI Test (A0100/6) is CE-marked in Europe in compliance with the EU IVD Directive 98/79/EC and registered in many non-European markets. Please check availability with a Biocartis representative. OPDIVO® and YERVOY® are registered trademarks of Bristol-Myers Squibb Company.
Cervantes, A., et al. (2023). Metastatic colorectal cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Annals of oncology: official journal of the European Society for Medical Oncology, 34(1), 10–32. https://doi.org/10.1016/j.annonc.2022.10.003
Andre, T. et al. (2024). Nivolumab plus Ipilimumab in Microsatellite-Instability-High Metastatic Colorectal Cancer. The New England journal of medicine, 391(21), 2014–2026. https://doi.org/10.1056/NEJMoa2402141
Andre, T. et al. (2024). Nivolumab plus Ipilimumab in Microsatellite-Instability-High Metastatic Colorectal Cancer. The New England journal of medicine, 391(21), 2014–2026. https://doi.org/10.1056/NEJMoa2402141
Product features
- Companion diagnostic to identify CRC patients with MSI-H status, who may benefit from treatment with OPDIVO® (nivolumab) in combination with YERVOY® (ipilimumab)1.
- Standardized MSI detection in a single-use cartridge without the need for matched normal sample.
- On average, < 3 minutes hands-on time (HoT) and 150 minutes turnaround time (TAT).
- One FFPE tissue section with ≥ 33% neoplastic cells and tissue area 25-300 mm2 (10 μm).
- Fully automated molecular walk-away system for on-demand testing in any setting.
Download Idylla versus IHC Leaflet
Quoted from the FDA-approved Intended Use. OPDIVO® and YERVOY® are registered trademarks of Bristol-Myers Squibb Company.
Why MSI detection matters for immunotherapy stratification in CRC patients
MSI-H tumors result from deficient DNA mismatch repair, leading to the accumulation of replication errors, particularly within microsatellite regions of the genome. The resulting frameshift mutations generate neoantigens that induce a robust immune response.
To evade detection by the immune system, tumor cells upregulate immune checkpoint pathways such as PD-1 / PD-L1, and CTLA-4. Blocking these pathways with ICI such as OPDIVO® (nivolumab) and YERVOY® (ipilimumab) restores T-cell activity, enabling recognition and destruction of tumor cells.
THE IDEAL SUSTAINABLE DIAGNOSTIC SOLUTION FOR LABS AND HCPs
1. EASY & OPTIMIZED LAB WORKFLOW
Precision medicine depends on accurate biomarker detection. As therapies increasingly rely on molecular diagnostics, labs are looking for solutions that simplify workflows and keep workloads manageable.
- The Idylla™ CDx MSI Test runs directly from FFPE tissue sections on the fully automated Idylla™ Platform. With just three minutes of hands-on time and no need for matched or external control samples, it streamlines testing and simplifies workflows.
2. OVERCOME DISPARITIES IN CRC OUTCOMES
Immunotherapy has been established as the first-line therapy for unresectable or metastatic MSI-H/dMMR CRC, but outcome disparities persist, in part due to limited or delayed access to molecular testing, which is critical for guiding timely and effective frontline therapy3, 4 .
- With the random-access capabilities enabled by the Idylla™ Platform, the Idylla™ CDx MSI Test delivers accurate MSI results in under three hours, in any lab - whether handling low-volume, decentralized testing or high-throughput, specialized workflows.
3. STANDARDIZATION, HIGH PERFORMANCE AND SPEED
Nearly one in seven CRC patients may receive suboptimal treatment when non-validated assays are used3 ,5, potentially compromising patient outcomes, and driving up costs from repeat or additional testing.
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The Idylla™ CDx MSI Test delivers standardized, straightforward and clinically validated MSI results, eliminating the need for results interpretation with a proven overall agreement rate of 98.57%.
Garcia-Carbonero, R. et al. (2024). Real-world study on microsatellite instability and mismatch repair deficiency testing patterns among patients with metastatic colorectal cancer in Spain. Clinical & translational oncology: official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico, 26(4), 864–871. https://doi.org/10.1007/s12094-023-03309-z
Garcia-Carbonero, R. et al. (2024). Real-world study on microsatellite instability and mismatch repair deficiency testing patterns among patients with metastatic colorectal cancer in Spain. Clinical & translational oncology: official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico, 26(4), 864–871. https://doi.org/10.1007/s12094-023-03309-z
Bozhar, H. et al. (2022). Socio-economic inequality of utilization of cancer testing in Europe: A cross-sectional study. Preventive medicine reports, 26, 101733. https://doi.org/10.1016/j.pmedr.2022.101733
Andre, T. et al. (2025). Nivolumab plus ipilimumab versus nivolumab in microsatellite instability-high metastatic colorectal cancer (CheckMate 8HW): a randomised, open-label, phase 3 trial. The Lancet, 405(10476), 383–395. https://doi.org/10.1016/S0140-6736(24)02848-4