Epigenomics offers the development of DNA methylation-specific assays for testing selected biomarker candidates in clinical samples. This step provides a first Clinical-Proof-of-Concept in a research setting before entering full IVD Test Development. For this purpose, Epigenomics uses one of its proprietary DNA methylation amplification technologies or the Affymetrix CGS3000Dx platform to develop specific DNA methylation assays.

These assay technologies are suitable for the analysis of formalin-fixed, paraffin-embedded as well as fresh-frozen samples, allowing the training and testing of DNA methylation assays in retrospective as well as prospective sample collections. Through its worldwide network of collaborators and sample providers, Epigenomics can assist in obtaining the best sample collections for our clients' needs.

Through its partner – Cogenics (www.cogenics.com) - Epigenomics now offers the DNA methylation analysis of established assays in regulated environments (GLP, GCP) suitable for generating data ready for regulatory submission.

Please inquire for a customized proposal for clinical proof-of-concept of your DNA methylation biomarker candidates.