Biocartis NV Secures FDA Clearance For Idylla™ CDx MSI Test, Expanding Diagnostic Capabilities

Biocartis Group of Companies, a leading molecular diagnostics company, has announced that its Idylla CDx MSI Test, developed in partnership with Bristol Myers Squibb, has received Premarket Approval (PMA) from the U.S. Food and Drug Administration (FDA). This is the first time a cartridge-based, fully automated companion diagnostic test has been granted PMA by the FDA.

The Idylla CDx MSI Test is designed to help healthcare professionals identify patients with microsatellite instability-high (MSI-H) colorectal cancer who may be suitable for treatment with OPDIVO (nivolumab) on its own or in combination with YERVOY (ipilimumab). These treatment recommendations are based on findings from the CheckMate-8HW clinical trial conducted by Bristol Myers Squibb.

Sarah Hersey, Vice President, Precision Medicine, Bioanalytical and Translational Sciences, Bristol Myers Squibb, stated, “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. 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.”

Michael Korn, M.D., Chief Medical and Scientific Officer at Biocartis, mentioned, 

“Achieving FDA approval for our Idylla™ CDx MSI Test represents a key milestone for Biocartis. 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 powerful solution that enables clinicians to make timely, confident and data-driven treatment decisions when every moment counts.”

The test operates on the Idylla Platform and qualitatively detects MSI in colorectal cancer tissue samples by analyzing a panel of seven monomorphic biomarkers: ACVR2A, BTBD7, DIDO1, MRE11, RYR3, SEC31A, and SULF2. It is designed for efficiency and ease of use, running on a single-use cartridge that requires less than three minutes of hands-on time and delivers accurate results in under three hours. This makes it a practical and reliable option for clinical settings, enabling faster and more precise decision-making for treatment planning.