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Biocartis

The Belgian oncology molecular diagnostics firm reported a 17 percent increase in product sales but said that sales of cartridges in the US were lower than expected. 

Biocartis' Idylla called some colorectal cancer samples negative that Sysmex Inostics's OncoBEAM called positive, but the clinical implications may be complex.

The agreement is part of Biocartis' long term plans to expand its presence in the oncology field by building a menu of tests for immunotherapies.

Idylla molecular testing instruments will be placed at Covance sites to support customer needs for clinical trials and to validate and implement companion diagnostic applications.

The deal will focus on Biocartis' Idylla MSI test, which provides information on a tumor's microsatellite instability status of a tumor from a single FFPE slice.

The firm will expand on its MSI assay for use in immunotherapy while developing liquid biopsy assays to monitor patients post therapy and for recurrence.

The firm plans to submit its Idylla MSI test for 510(k) clearance from the US Food and Drug Administration after receiving CE-IVD approval this morning.

The RT-qPCR-based assay, which has 510(k) clearance, is designed to rapidly differentiate sepsis from systemic inflammatory response syndrome.

The firm said it raised €55.5 million to fund the expansion of its Idylla test platform, its sales and marketing activities, and other general corporate purposes.

The Belgium-based firm plans to use the proceeds to fund expansion of the Idylla test platform, sales and marketing activities, and additional general corporate purposes.

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