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DxS Gets CE-IVD Mark for TheraScreen Test on Roche's LightCycler

NEW YORK (GenomeWeb News) – Molecular diagnostics developer DxS has received European Union approval to sell its TheraScreen K-RAS Mutation Kit for use on Roche's LightCycler 480 Instrument II.

DxS said that the CE-IVD Mark will enable the firm to sell the test, which is used to monitor patient response to Amgen's panitumumab (Vectibix) and Merck's cetuximab (Erbitux) drugs for colorectal cancer, in clinical settings in the EU.

In addition, DxS said today that it has licensed Roche's LightCycler Adapt Software v1.1 to be used with the TheraScreen test kits. It said that the software will offer automated processing of K-RAS mutation status tests for colorectal cancer patients.

Manchester, UK-based DxS said that the software will be available for installation in territories where the K-RAS Mutation Kit is available for sale through Roche, including Europe, Saudi Arabia, South Africa, and Australia.

Financial terms of the agreement were not released.

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