September 16, 2025
1 min read
The FDA has approved the Idylla CDx MSI test — a fully automated, “sample-to-result” companion diagnostic — for patients with colorectal cancer, according to a press release.
The test, developed by Biocartis in partnership with Bristol Myers Squibb, helps identify patients with microsatellite instability-high (MSI-H) CRC who may benefit from treatment with nivolumab (Opdivo, Bristol Myers Squibb) alone or in combination with ipilimumab (Yervoy, Bristol Myers Squibb).
The FDA has approved the Idylla CDx MSI test — a fully automated, “sample-to-result” companion diagnostic — for patients with colorectal cancer.
“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,” Sarah Hersey, vice president of precision medicine, bioanalytical and translational sciences at Bristol Myers Squibb, said in the release. “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.”
The Idylla CDx MSI test detects seven monomorphic biomarkers — ACVR2A, BTBD7, DIDO1, MRE11, RYR3, SEC31A and SULF2 — to identify MSI in CRC tissue samples. The cartridge-based test is designed for use on the Idylla platform and requires less than 3 to perform. Results are delivered in less than 3 hours.
“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,” Michael Korn, MD, Biocartis’ chief medical and scientific officer, said in the release.
The test will soon be available in the United States, with other markets to follow.
