The company is developing and validating assays for difficult-to-treat and drug-resistant infectious diseases based primarily on targets, biomarkers, and PCR primers developed at the Translational Genomics Research Institute and Northern Arizona University.
The test, which amplifies and detects methylated Septin9 DNA from patient plasma samples, has been shown to identify a higher proportion of colorectal cancers than Quest Diagnostics' laboratory-developed test, called ColoVantage; as well as CE-marked in vitro diagnostics offered in Europe by Epigenomics and Abbott.
Life Tech officials said that Stokes Bio's microfluidics-based technology platform will enable high-throughput, PCR-based genetic analyses for a variety of applications, particularly in the area of agricultural biology.
Synlab has started offering Epi proColon, Epigenomics' PCR-based blood test for early detection of colorectal cancer, through 55 German sites in its network. In addition, Epigenomics recently raised €33.1 million ($44.2 million) through a combined private and public share offering.
European customers using or planning to use the 7500 Fast Dx instrument to develop in vitro diagnostic content now have a "much easier" path when submitting a complete IVD platform for regulatory approval by European authorities, a Life Tech official said.
The Berlin-based company is planning to market the test in Germany, Switzerland, and Austria. Epigenomics will partner with distributors Abbott Molecular and Quest Diagnostics to launch the test in other European countries, as well as the US.