Biocartis Group of Companies (Biocartis), an innovative molecular diagnostics company, announced that the U.S. Food and Drug Administration (FDA) has granted Premarket Approval (PMA) for its Idylla CDx MSI Test. This marks the first FDA-approved, fully automated, “sample-to-result,” cartridge-based companion diagnostic test in the United States for colorectal cancer (CRC) patients.

Developed in partnership with Bristol Myers Squibb, the Idylla CDx MSI Test helps identify patients with microsatellite instability-high (MSI-H) colorectal cancer who may be eligible for treatment with OPDIVO (nivolumab) alone or in combination with YERVOY (ipilimumab). These treatment options are supported by data from the CheckMate-8HW trial (Bristol Myers Squibb Company).

 “The approval of this new MSI companion diagnostic for patients with colorectal cancer is a meaningful milestone in our collaboration with Biocartis and a testament to our precision medicine strategy at Bristol Myers Squibb,” said Sarah Hersey, Vice President, Precision Medicine, Bioanalytical and Translational Sciences, Bristol Myers Squibb. “Rapid and accurate diagnosis is essential to ensuring that patients can access the most appropriate therapeutic options, and this advancement underscores our commitment to innovative, targeted solutions that can improve patient outcomes.”

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) to determine MSI status in colorectal cancer tissue samples. The fully automated test requires less than three minutes of hands-on time and delivers clear, actionable results in under three hours.

“FDA approval of the Idylla CDx MSI Test represents a significant milestone for Biocartis and a critical step forward for colorectal cancer care,” said Michael Korn, M.D., Chief Medical and Scientific Officer at Biocartis. “This achievement reflects our mission to ensure oncology patients receive the right therapy without unnecessary delays. With its speed, accuracy, and ease of use, the Idylla CDx MSI Test provides clinicians with a powerful diagnostic tool to guide timely and confident treatment decisions.”

The Idylla CDx MSI Test will be available in the United States in the near future, with plans to expand to additional global markets thereafter.