Automated MSI Test Gains IVDR Certification to Guide CRC Therapy

Timely results can help clinicians decide on immunotherapy options. A newly IVDR-certified companion diagnostic test now provides rapid, automated determination of microsatellite instability to support such decisions.

Biocartis (Mechelen, Belgium) has received Class C companion diagnostic (CDx) certification under the European In Vitro Diagnostic Medical Device Regulation (EU 2017/746) for the Idylla CDx MSI Test as a companion diagnostic for colorectal cancer (CRC). The certification designates the assay as an aid to identify adult patients with microsatellite instability‑high (MSI‑H) metastatic CRC who may benefit from treatment with nivolumab in combination with ipilimumab. It is the company’s second fully automated companion diagnostic approval under the IVDR, following the Idylla EGFR Mutation Test certified in May 2025.

Designed for the Idylla Platform, the Idylla CDx MSI Test qualitatively determines MSI‑H or microsatellite stable (MSS) status in colorectal cancer tissue. The Idylla Platform is a fully automated, PCR-based molecular diagnostics system developed by Biocartis to provide rapid, lab-quality results in a decentralized setting. It utilizes a unique all-in-one cartridge technology that integrates sample preparation—including DNA/RNA extraction—with amplification and detection. This streamlined design requires less than three minutes of hands-on time and delivers results in approximately 85 to 180 minutes, significantly reducing the turnaround time for critical clinical decisions in areas such as oncology and infectious diseases.

The company notes that this European certification builds on prior approval in the United States. The IVDR‑certified Idylla CDx MSI Test will be available soon to customers across Europe and in additional regions where IVDR regulations apply. The test is already commercially available in the United States.

“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. 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" said Roger Moody, Chief Executive Officer of Biocartis

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