NEW YORK (GenomeWeb News) – Epigenomics today announced it has signed an original equipment manufacturing deal with Life Technologies for the supply of Dynabeads MyOne Silane and buffers for Epi proColon 2.0, the second generation colorectal cancer test being developed by the German firm.
The test is in development for the US and European in vitro diagnostic market, and Epigenomics anticipates submitting a premarket approval application to the US Food and Drug Administration before the end of the year.
Epigenomics said that a key element of the test is the use of Life Tech's Dynabeads MyOne Silane — monosized magnetized beads that bind nucleic acids in biological samples. The use of a magnetic field allows for separation of the Dynabeads-nucleic acid complex and the concentration of nucleic acids for diagnostic analysis, such as the detection of methylated DNA of the Sept9 gene.
Epi proColon 2.0 targets the biomarker, and compared to the first generation of the test requires fewer components and handling steps. Results can be achieved in eight hours, making it simpler to automate on various IVD automation solutions, Epigenomics said.
It added that it currently is transferring the cGMP manufacturing of the test to its contract manufacturer, NextPharma, in San Diego.
Financial and other terms of the deal were not disclosed.