Biocartis Files for FDA Clearance for Colon Cancer Test

April 21, 2021

Biocartis has submitted a 510(k) application to the FDA for its Idylla MSI Test, a diagnostic designed to distinguish between sporadic colon cancer and Lynch syndrome, a common cause of hereditary colon cancer.

The test looks for microsatellite instability (MSI), which measures the predisposition to mutation when DNA mismatch repair is not functioning normally.  

The fully automated test delivers information on the MSI status of colon cancer tumors within approximately 150 minutes using a single slice of tumor tissue.

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