Idylla CDx MSI Test

CDx for OPDIVO® (nivolumab) ± YERVOY® (ipilimumab) for MSI-H CRC patients

~150 minutes assay turnaround time

< 3 minutes hands-on time

Directly from 1 FFPE section & no paired tissue samples needed

Highly sensitive & standardized

Unbiased result reporting

IDYLLA™ CDx MSI TEST (IVD)

REF: A0220/6 | CPT: 81301

The Idylla™ CDx MSI Test is the first-ever fully automated, sample-to-result companion diagnostic for CRC patients, setting a new benchmark in ease of use and rapid turnaround to identify CRC patients eligible for OPDIVO® (nivolumab) alone or in combination with YERVOY® (ipilimumab).

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.
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.
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 population2.

Download Clinical Background Leaflet

Approved in the US under P250005. OPDIVO® and YERVOY® are registered trademarks of Bristol-Myers Squibb Company.

NCCN guidelines Colon Cancer version 4.2025
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) as a monotherapy and/or treatment with OPDIVO^® (nivolumab) in combination with YERVOY^® (ipilimumab)3.
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 Leaflet Download Technical Sheet

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 therapy4.

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 used4 ^,5, potentially compromising patient outcomes, and driving up costs from repeat or additional testing.

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%.

Froelich, W. (2020). Disparities in MSI/MMR Biomarker Testing for Colorectal Cancer. Oncology Times, 42(22), p 35. https://doi.org/10.1097/01.COT.0000723664.21999.cc

Froelich, W. (2020). Disparities in MSI/MMR Biomarker Testing for Colorectal Cancer. Oncology Times, 42(22), p 35. https://doi.org/10.1097/01.COT.0000723664.21999.cc
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

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