Biocartis announces US FDA 510(k) submission of its Idylla MSI test

Biocartis

20 April 2021 - First US FDA oncology assay submission for Biocartis.

Biocartis today announces the US FDA 510(k) submission of its Idylla MSI test for use as an in vitro diagnostic device intended for the identification of microsatellite instability status in colorectal cancer to aid in the differentiation between sporadic colorectal cancer and potential Lynch syndrome.

Read Biocartis press release

Michael Wonder

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Michael Wonder

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Cancer , US , Dossier , Diagnostic agent