Idylla CDx MSI test gets FDA premarket approval
October 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.