Under the terms of the agreement, Epigenomics will combine its methylation analysis capabilities, including DNA bisulfite treatment, with Qiagen's know how in preanalytical sample preperation technologies in life sciences and molecular diagnostics.
Bisulfite treatment of DNA, a technology of which is Epigenomics' focus, is a critical and time consuming preanalytical step to enable analysis of DNA methylation on today's standard detection platforms. Bisulfite treatment is an integrated complex chemical modification of DNA following collection, stabilisation and purification of the sample.
The collaboration also sees Qiagen obtaining a worldwide exclusive license to develop, manufacture, market and sell preanalytical solutions containing bisulfite treatment technology for research purposes.
This will be especially significant within the diagnostics field. Qiagen will market and sell stand-alone preanalytical solutions containing bisulfite treatment technology for use with Epigenomics' proprietary technologies and products.
In addition, Qiagen has also received worldwide exclusive rights to Epigenomics' MethyLight assay technology for use in research applications and intends to develop first standardised reagent solutions for methylation pattern analysis.
Under an additional OEM (Original Equipment Manufacturer) agreement, Qiagen will provide Epigenomics with kit components as the preanalytical basis for Epigenomics' product pipeline of molecular diagnostic products.
All products developed under the agreement will be co-branded. First products are expected to be launched in 2006. Under the terms of the agreement, Qiagen will pay up-front technology access and licensing fees, as well as royalties on all research products sales to Epigenomics. Further financial details of the agreement were not disclosed.
The ability to detect and quantify DNA methylation efficiently and accurately is an essential tool for scientists to study the role of epigenetic changes in cancer and other serious diseases, as well as many other clinical applications.
Methylation is a natural process that occurs when a methyl group binds to one of DNA's four bases, cytosine. The presence of methylation is responsible for controlling the activity of genes by turning them off, like a switch, when not needed. By measuring the differences in the methylation patterns between healthy and diseased tissue, a change in gene activity that could trigger diseases such as cancer is detected.
"We hope to make possible horizontal integration of SNPs (single nucleotide polymorphisms) with methylation-based gene activity analysis, as well as eventually to provide vertical integration by offering perfect preanalytical modules for all possible types of customers, from basic research, through clinical studies and right into regulated IVD settings," said Alexander Olek, CEO of Epigenomics.
Epigenomics' strategy in partnering with Qiagen stems from the assumption that clinical research use will be the most significant factor in the decision to include them into later IVDs. This is where the standardisation of IVDs on its platform may allow initiate research in earlier phases based on products that will likely re-appear in quasi-identical form in regulated IVDs.
The application of methylation research in clinical studies has demonstrated exciting momentum. Many of these methylation-related biomarkers are proving that they have very powerful and robust diagnostic value in research, clinical research and molecular diagnostics.
"We are expecting methylation research to have a strong role in clinical biomarker studies and molecular diagnostics," said Peer Schatz, CEO of Qiagen.
"The complexity of the preanalytical steps in methylation analysis up until today has represented a significant challenge and impediment for even faster growth of this sector."