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Biocartis Files FDA Submission for Microsatellite Instability Test in Colorectal Cancer

NEW YORK — Biocartis said on Tuesday that it has filed a 510(k) submission to the US Food and Drug Administration for its Idylla MSI test for use as an in vitro diagnostic device.

The Belgium-based firm's CE-marked assay is intended to detect microsatellite instability status in colorectal cancer to help differentiate between sporadic CRC and potential Lynch syndrome. It is the first oncology assay that Biocartis is submitting for FDA clearance.

Biocartis said that the Idylla MSI test provides actionable data in about 2.5 hours from a single slice of formalin-fixed, paraffin-embedded tumor tissue, without the need for a reference sample.

"Once the 510(k) clearance is obtained, both large and small US labs are expected to benefit from this fast and easy-to-use Idylla MSI testing thanks to the fully automated sample-to-result nature of our platform," Herman Verrelst, CEO of Biocartis, said in a statement. "We continue to build momentum in our regulatory program and plan to submit more products to the US FDA, also supported by our pharma partners."