DXS has achieved 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.
This software allows automated testing of K-RAS mutation status of colorectal cancer patients.
The test helps doctors to identify a patient's response to anti-EGFR therapies for colorectal cancer.
DXS also secured a licence to provide Roche's Lightcycler Adapt 1.1 software to be used with its Therascreen: K-RAS mutation kits.
Lightcycler Adapt 1.1 is a specialised software package for use with the Lightcycler 480 Instrument II, and provides automated data processing, avoiding manual interpretation and human error.
The software generates data compatible with both LIMS (laboratory information management system) and PMS (patient management system), and produces the results in a read-only format, ensuring patients' results are secure.
The software has a built-in warning system that generates a troubleshooting message if an assay has not been run correctly.
Lightcycler Adapt 1.1 for Therascreen: K-RAS mutation kit (CE-IVD) is available for installation in territories where the K-RAS mutation kit 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.
