March 2023 –
Biocartis, Inc. received FDA approval to market their IdyllaTM MSI test. The IdyllaTM MSI test is a fully automated test, producing results in less than three hours.
Unique to most other MSI test kits on the market, matched normal tissue is not needed and formalin-fixed, paraffin-embedded (FFPE) colorectal cancer tissue sections are fed directly into the machine, which then reports the tissue as microsatellite stable (MSS) or microsatellite instability high (MSI-H) or invalid in under 3 hours. MSI-H tumors are characteristic of Lynch syndrome. The Colorectal Cancer Family Registry contributed colorectal cancer tumors for their FDA filing.
The poster below describes the development and testing of the IdyllaTM MSI Test.