K-RAS Mutation Kit (CE-IVD) Available for Use in European Union on the Roche LightCycler^® 480 Instrument II

DxS, a personalised medicine company, has CE Mark certification of the TheraScreen®: K-RAS Mutation Kit (CE-IVD) for use on 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-EGFR therapies for colorectal cancer. DxS also secured a license to provide Roche’s LightCycler® Adapt Software v1.1 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.

Dr Stephen Little, CEO of DxS said: “This is excellent news for our customers. Not only do they have access to the TheraScreen®: K-RAS Mutation Kit, but they can now use the LightCycler® Adapt Software v1.1 for TheraScreen®: K-RAS Mutation Kit (CE-IVD)to help run the assay and interpret results, making our highly-sensitive K- RAS test the most user-friendly option currently available.”

LightCycler® Adapt Software v1.1 for TheraScreen®: K-RAS Mutation Kit (CE-IVD) is a specialised 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 LIMS (Laboratory Information Management System) and PMS (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 which generates a troubleshooting message if an assay has not been run correctly.

The LightCycler® Adapt Software v1.1 for TheraScreen®: K-RAS Mutation Kit (CE-IVD) is available for installation in territories where the TheraScreen®: K-RAS Mutation Kit (CE-IVD) is available for sale via Roche. These include Europe, Saudi Arabia, South Africa and Australia. Customers can ask their local Roche representative for further information.