PRESS RELEASE: Biocartis and Amgen sign a RAS Biomarker Testing Collaboration in Europe

Mechelen, Belgium, 22 December 2016 - Biocartis Group NV (‘Biocartis’), an innovative molecular diagnostics company (Euronext Brussels: BCART), today announced the signing of a new collaboration agreement with Amgen, a leading biotechnology company. The new agreement, which builds on the existing collaboration between both companies announced on 3 February 20161, aims at accelerating access to RAS biomarker information in up to 10 European countries.

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PRESS RELEASE: Biocartis submits 510(k) file with US FDA for Idylla™ platform

Submission done in parallel with 510(k) submission of Janssen Idylla™ Respiratory (IFV-RSV) Panel Test by Janssen Diagnostics

 

Mechelen, Belgium, 22 December 2016 - Biocartis Group NV (‘Biocartis’), an innovative molecular diagnostics company (Euronext Brussels: BCART), today announced the 510(k) submission1 to the U.S. Food and Drug Administration (FDA) of its rapid, fully automated molecular diagnostics platform Idylla™, consisting of the Idylla™ Instrument and the Idylla™ Console.

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PRESS RELEASE: CE-marking Idylla™ NRAS-BRAF Mutation Test completes offering of metastatic colorectal cancer tests for clinical use on Idylla™ platform

Mechelen, Belgium, 15 December 2016 - Biocartis Group NV (‘Biocartis’), an innovative molecular diagnostics company (Euronext Brussels: BCART), today announces the CE-marking of its solid biopsy Idylla™ NRAS-BRAF Mutation Test. Together with the CE-marked Idylla™ KRAS Mutation Test, Biocartis is now able to offer its customers a complete testing for metastatic colorectal cancers1 (mCRC) for clinical use on its Idylla™ molecular diagnostics platform, as recommended by the most recent clinical guidelines. The ability of Biocartis’ RAS test offering to enable same-day results can now open routes towards faster treatment selection for mCRC patients.

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