Sept. 18, 2025—Biocartis’ Idylla CDx MSI test, developed in partnership with Bristol Myers Squibb, has received FDA premarket approval. The test aids in identifying eligible microsatellite instability-high colorectal cancer patients who may benefit from treatment with Opdivo (nivolumab) alone or in combination with Yervoy (ipilimumab), as established in the CheckMate 8HW trial.
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 detection of MSI in colorectal cancer tissue samples. The test runs in a single-use cartridge, requires less than three minutes of hands-on time, and delivers results in less than three hours.