FDA Approves Biocartis’ Idylla CDx MSI Test

The Idylla CDx MSI Test from Biocartis Group of Companies has earned U.S. Food and Drug Administration Premarket Approval (PMA) for a cartridge-based, fully automated, “sample-to-result” companion diagnostic test.

Developed with Bristol Myers Squibb, the Idylla CDx MSI Test helps identify eligible microsatellite instability-high (MSI-H) colorectal cancer (CRC) patients who may benefit from treatment with OPDIVO (nivolumab) alone, or in combination with YERVOY (ipilimumab), as established in the CheckMate-8HW trial (André et al., 2024¹; André et al., 2025²).³

“The approval of this new MSI companion diagnostic for patients with colorectal cancer is a meaningful achievement from our collaboration with Biocartis and a strong reflection of our Precision Medicine strategy at Bristol Myers Squibb,” said Sarah Hersey, vice president of Precision Medicine, Bioanalytical and Translational Sciences, Bristol Myers Squibb. “Rapid and accurate diagnosis is crucial to enabling access to appropriate therapeutic approaches, and this latest advancement exemplifies our commitment to delivering innovative, targeted solutions that have the potential to improve outcomes for patients.”

Designed for use on the Idylla Platform, the Idylla CDx MSI Test qualitatively detects a panel of seven monomorphic biomarkers (ACVR2A, BTBD7, DIDO1, MRE11, RYR3, SEC31A and SULF2) for detecting MSI in CRC tissue samples. The Test runs in a single-use cartridge, requiring less than three minutes of hands-on-time and delivering straightforward results in under three hours.

“Achieving FDA approval for our Idylla CDx MSI Test represents a key milestone for Biocartis,” Biocartis Chief Medical and Scientific Officer Michael Korn, M.D., stated. “It underscores our commitment to helping oncology patients receive the right therapy without delay and the recent CheckMate-8HW data reinforce the critical importance of accurate MSI-H/dMMR testing in colorectal cancer. With its speed, accuracy, and automation, the Idylla CDx MSI Test offers a solution that enables clinicians to make timely, data-driven treatment decisions when every moment counts.”

The Idylla CDx MSI Test will available soon in the United States, and other non-U.S. markets will follow.

Biocartis’ proprietary Idylla Platform delivers in-house molecular biomarker results in three hours, enabling healthcare professionals to make timely, informed decisions that guide personalized therapy. Its diagnostic tests and research assays addresses key unmet clinical needs across multiple cancers, including lung, skin, thyroid, colorectal, endometrial, blood, brain, and breast cancer.

References
¹ 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
² 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
³ Please see U.S. Full Prescribing Information for OPDIVO and YERVOY.