Epigenomics AG has reached a milestone in completing the work on an optimized assay procedure for its blood-based cancer screening tests. The most advanced of these, the colorectal cancer screening test, is now ready for its planned reference laboratory transfer.
After having demonstrated the performance of its biomarker Septin 9 for the detection of colorectal cancer in blood plasma in December 2006, Epigenomics had focused on the improvement of the assay procedure used to process the patient blood plasma samples and measure the biomarker.
In four projects, Epigenomics worked systematically on all major steps of its research workflow to develop an improved assay procedure compatible with routine clinical use and automation.
In a technical study, the company tested each improvement separately and their overall combined impact, and demonstrated now that the optimized assay procedure analytically performs equally or better to the previously used research workflow.
In addition the throughput of patient samples that can be processed in parallel by a lab technician was doubled while DNA extraction and the biomarker assay are now compatible with widely available laboratory automation solutions. This allows further increasing of throughput for mass screening applications.
The assay procedure could now be applied to routine clinical use and is now ready for its planned transfer into a reference laboratory to establish a commercial testing service for Epigenomics’ proprietary colorectal cancer early detection biomarker Septin 9.
The modified assay procedure also marks a milestone towards the planned development of an in vitro diagnostic (IVD) test kit for automated molecular diagnostics platforms of potential diagnostic industry partners that want to commercialize Epigenomics’ colorectal cancer screening test broadly.