The partnership between the two molecular diagnostics companies has resulted in products that include real-time PCR kits for Epigenomics' proprietary biomarkers and reference assay kits produced under the brand name LightMix.
The LightMix kits include the GSTP1 kit for DNA methylation analysis of the GSTP1 gene - possibly amongst the best described DNA methylation biomarkers in prostate cancer research.
Research has shown that methylated DNA of the GSTP1 gene in tissue as well as in urine is a biomarker in prostate cancer indications. As DNA methylation in gene regulatory regions (i.e. gene promoters) helps control gene activity, it is hoped that DNA methylation will eventually provides a rich source for highly specific biomarkers for organ-specific disease diagnosis, classification and prediction for therapeutic intervention.
The kits are based on Epigenomics' HeavyMethyl (HM) technology containing premixed PCR primers, blockers and probes for 48 PCR reactions as well as positive controls.
Further products launched at the fair include the LightMix Kit Reference G for the quantification of bisulfite converted DNA and standard DNAs for DNA methylation quantification.
Epigenomics and TIB Molbiol also launched a LightMix product for Epigenomics' colorectal cancer biomarker Septin 9 in the second quarter of 2008 followed by further LightMix products for biomarkers with potential applications in cancer diagnosis and cancer classification.
The products will be produced under the brand name LightMix by TIB Molbiol under license from Epigenomics. Furthermore, the products launched include DNA methylation quantification standards produced by Epigenomics.
Epigenomics will be the sole distributor of the product line in Europe and other regions excluding the U.S.
"With the launch of the first molecular IVD products based on our DNA methylation biomarkers in reach, we believe that it is important to enable the biomedical research community to gain experience with these outstanding biomarkers early on," said Geert Nygaard, chief executive of Epigenomics.
"Providing high-quality kits for DNA methylation biomarker research, will support the market acceptance of future DNA methylation based molecular diagnostic products," he added.
With the launch of the kits, Epigenomics addresses the increasing demand by medical researchers and specialty diagnostics laboratories primarily in Europe interested in using these biomarkers for applications in cancer detection and cancer classification.
Human cancer is characterised by abnormal patterns of methylated DNA involving thousands of genes. The pattern of methylation in small subset of genes can be used as very sensitive and specific diagnostic or prognostic test for cancer.
Published data shows that prostate cancer could be detected with a sensitivity and specificity of nearly 100 per cent by detecting the methylation status of only 10 genes.
According to D&MD, the potential market overlaps strongly with that for RNA interference (RNAi), a market predicted to reach $185m by this year.
Along with Epigenomics, major players in this sector include Rubicon, Qiagen and Agilent Technology all addressing markets with a potential target group of over 300 million individuals worldwide.
