April 2026—Biocartis’ Idylla CDx MSI test has received class C companion diagnostic certification under the European Union IVDR. It is indicated as an aid to identify adult patients with microsatellite instability-high metastatic colorectal cancer who may benefit from treatment with nivolumab in combination with ipilimumab. The test qualitatively detects MSI-H/MSS in CRC tissue samples within a single-use cartridge on the Idylla platform. It requires less than three minutes of hands-on time and delivers results in less than three hours.
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