The test provides fully automated, sample-to-result testing to identify patients eligible for immunotherapy treatment.
The US Food and Drug Administration has granted premarket approval for the Idylla CDx MSI Test, a cartridge-based companion diagnostic developed by Biocartis in partnership with Bristol Myers Squibb to identify colorectal cancer patients who may benefit from immunotherapy treatment.
The test aids in identifying microsatellite instability-high (MSI-H) 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 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, requiring less than three minutes of hands-on time and delivering results in under three hours.
“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,” says Sarah Hersey, vice president, precision medicine, bioanalytical and translational sciences, Bristol Myers Squibb, in a 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.”
Fully Automated Testing Platform
The approval marks the FDA’s approval of a cartridge-based, fully automated, sample-to-result companion diagnostic test. The system’s automation reduces manual intervention while providing standardized results for MSI testing in colorectal cancer patients.
“Achieving FDA approval for our Idylla CDx MSI Test represents a key milestone for Biocartis,” says Michael Korn, MD, chief medical and scientific officer at Biocartis, in a release. “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.”
The CheckMate-8HW trial data, published in The New England Journal of Medicine and The Lancet, established the efficacy of nivolumab alone or in combination with ipilimumab for treating MSI-H metastatic colorectal cancer patients.
Market Availability
Biocartis plans to make the Idylla CDx MSI Test available across the US soon, with availability in other non-US markets expected to follow. The company has not disclosed specific pricing or distribution timelines for the test.
The approval adds to the growing portfolio of companion diagnostics designed to support precision medicine approaches in oncology, particularly for identifying patients who may respond to immunotherapy treatments based on specific biomarker profiles.
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