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FDA-approved companion diagnostic

Idylla CDx MSI Test

Fully automated real-time PCR assay on the Idylla platform that determines microsatellite instability (MSI) status directly from FFPE tumor tissue.

IVD-developed CDxMethod: PCRSpecimen: Tissue (FFPE)Biomarker: Microsatellite instability (MSI)
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Casandra.ai provides a unified ordering experience so you can request this test directly from the performing lab, without changing your workflow.

Ordering is available where Casandra has an active integration with the performing lab. Labs that offer this test can connect with us to enable digital ordering.

About this test

FDA approval details
PMA number
P250005
Supplements
Manufacturer
Biocartis US Inc.
Approval date
August 15, 2025
Test specifications
Methodology
PCR
Specimen
Tissue (FFPE)
Report format
Comprehensive report PDF
Turnaround (typical)
Not specified
Biomarker(s)
Microsatellite instability (MSI)
What this test is

Idylla CDx MSI Test is an FDA-approved, fully automated real-time PCR assay that analyzes DNA from formalin-fixed, paraffin-embedded tumor tissue to qualitatively determine microsatellite instability (MSI) status. Performed on the Idylla cartridge-based system, it uses a panel of monomorphic markers and integrated analysis software to classify tumors as MSI-high or MSI-stable, supporting prognosis and treatment planning in eligible patients.

Where this test fits

IndicationBiomarkerBiomarker detailsTherapy (Select a therapy to open its FDA-approved testing pathway)
Colorectal Cancer (CRC)ACVR2A, BTBD7, DIDO1, MRE11, RYR3, SEC31A and SULF2Microsatellite instability-High (MSI-H)OPDIVO, OPDIVO + YERVOY

IVD Manufacturer

Biocartis US Inc.

Biocartis is committed to helping cancer patients worldwide access the right treatment faster. With our proprietary Idylla™ Platform, we deliver in-house molecular biomarker results in only 3 hours, enabling healthcare professionals to make timely, informed decisions that guide personalized therapy. Our expanding portfolio of diagnostic tests and research assays addresses key unmet clinical needs across multiple cancers, including lung, skin, thyroid, colorectal, endometrial, blood, brain, and breast cancer. Learn more at www.biocartis.com and follow us on LinkedIn, Facebook and X (Twitter).

Order this test

If your organization is connected to Casandra, you can place an electronic order forIdylla CDx MSI Test directly from your existing workflow.

Casandra connects providers, labs, and sponsored programs so that companion diagnostics can be ordered consistently and documented cleanly, regardless of which system you start from.

CDxTests.com is an informational resource for providers. Always refer to the official FDA labeling and laboratory documentation when making treatment decisions.

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