DxS gets CE mark for TheraScreen K-RAS kit

29 March 2009

DxS, a UK personalized medicine company, has CE Mark certification of the TheraScreen: K-RAS Mutation Kit for use on Swiss drug major Roche's  LightCycler 480 Instrument II, allowing it to be sold for clinical use  in the European Union.

The test helps doctors to identify a patient's K-RAS mutation status and  response to anti-epidermal growth factor receptor therapies for  colorectal cancer. DxS also secured a license to provide Roche's  LightCycler Adapt Software version 1.1 to be used with its TheraScreen:  K-RAS Mutation Kits. The software allows automated processing of K-RAS  mutation status tests for colorectal cancer patients.

LightCycler Adapt Software v1.1 for TheraScreen: K-RAS Mutation Kit is a  specialized software package for use with the LightCycler 480 Instrument  II, which provides automated data processing, avoiding manual  interpretation and human error. The software generates data that is  compatible with both Laboratory Information Management System and  Patient Management System, and produces the results in a read-only  format, ensuring patient's results are secure. In addition, the software  has a built-in warning system that generates a troubleshooting message  if an assay has not been run correctly.

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