Biocartis Receives FDA Approval for Colorectal Cancer Test

Biocartis Group NV has received US FDA approval for its colorectal cancer test, which can analyze biomolecules associated with risk factors, early detection, treatment selection, and disease monitoring. The Idylla system can deliver results within 35-150 minutes.

Biocartis Group NV has received a significant milestone in the form of US FDA approval for its Idylla™ CDx MSI Test. This innovative diagnostic tool is designed to aid in the identification of eligible microsatellite instability-high (MSI-H) colorectal cancer (CRC) patients who may benefit from treatment with OPDIVO® (nivolumab) alone or in combination with YERVOY® (ipilimumab), as established in the CheckMate-8HW trial Press Release Biocartis NV: Biocartis Receives FDA Approval for the Idylla™ CDx MSI Test^[1].

The Idylla™ CDx MSI Test, developed in partnership with Bristol Myers Squibb, is the first fully automated, sample-to-result, cartridge-based companion diagnostic test approved in the US. It qualitatively detects a panel of seven monomorphic biomarkers (ACVR2A, BTBD7, DIDO1, MRE11, RYR3, SEC31A, and SULF2) in CRC tissue samples, delivering straightforward results in under three hours Press Release Biocartis NV: Biocartis Receives FDA Approval for the Idylla™ CDx MSI Test^[1].

"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," said Sarah Hersey, Vice President, Precision Medicine, Bioanalytical and Translational Sciences, 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" Press Release Biocartis NV: Biocartis Receives FDA Approval for the Idylla™ CDx MSI Test^[1].

The Idylla™ CDx MSI Test will be made available across the US soon, with availability in other non-US markets expected to follow. This approval represents a key milestone for Biocartis, underscoring its commitment to helping oncology patients receive the right therapy without delay. The test's speed, accuracy, and automation make it a powerful tool for clinicians, enabling them to make timely, confident, and data-driven treatment decisions Press Release Biocartis NV: Biocartis Receives FDA Approval for the Idylla™ CDx MSI Test^[1].