Biocartis Reports the US FDA’s Approval of Idylla CDx MSI Test to Identify MSI-H Colorectal Cancer Patients

Shots:

• The US FDA has approved the PMA application for Idylla CDx MSI Test, a cartridge-based, fully automated “sample-to-result” companion diagnostic, with US launch anticipated soon & availability in other non-US markets to follow
• The Idylla CDx MSI Test helps identify MSI-H colorectal cancer pts eligible for Opdivo (nivolumab) alone or with Yervoy (ipilimumab), as established in P-III (CheckMate-8HW) trial
• The Idylla CDx MSI Test, co-developed with BMS, qualitatively detects 7 MSI biomarkers (ACVR2A, BTBD7, DIDO1, MRE11, RYR3, SEC31A & SULF2) in CRC tissue using a single-use cartridge, needing <3min. hands-on time & delivering results in <3hrs.

Ref: Biocartis | Image: Biocartis| Press Release

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