The Idylla CDx MSI Test detects microsatellite instability in colorectal cancer tissue in under three hours, supporting therapy selection for eligible patients.

Biocartis has received Class C companion diagnostic (CDx) certification under the European Union’s In Vitro Diagnostic Medical Device Regulation (IVDR) for its Idylla CDx MSI Test, the company announced.

The test is indicated as an aid to identify adult patients with microsatellite instability-high (MSI-H) metastatic colorectal cancer (CRC) who may benefit from treatment with nivolumab in combination with ipilimumab. It marks the second CDx approval Biocartis has received under the IVDR, following the May 2025 certification of the Idylla EGFR Mutation Test, according to the company.

Designed for use on the Biocartis Idylla™ Platform, the test qualitatively detects MSI-H and microsatellite stable (MSS) status in CRC tissue samples using a single-use cartridge. According to Biocartis, the workflow requires less than three minutes of hands-on time and delivers results in under three hours.

“In May 2025, we received IVDR certification for the Idylla EGFR Mutation Test and have now expanded our IVDR-approved portfolio with the Idylla CDx MSI Test,” says Roger Moody, chief executive officer of Biocartis, in a release. “Building on its FDA approval in the United States, the Idylla CDx MSI Test is now also empowering clinicians across Europe with rapid and reliable results that support groundbreaking therapy selection for CRC patients, enabling timely and informed treatment decisions when every moment counts.”

The test has been commercially available in the US following approval by the Food and Drug Administration under P250005. The IVDR-certified version will be available soon to customers across Europe and additional regions where IVDR regulations apply, according to the company.

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