EpigenDx provides GLP and GCP compliant laboratory services that meet the requirements of regulatory authorities for genetic and epigenetic biomarker discovery and validation. EpigenDx is committed to and maintains the highest standards in quality assurance under a controlled environment.
- GLP/GCP compliant genetic testing includes mutation analysis using Pyrosequencing and real-time PCR. Target mutation analysis includes cancer biomarkers testing such as BRAF mutation analysis, EGFR mutation analysis, IDH1/IDH2 mutation analysis, and more.
- GLP/GCP compliant epigenetic testing includes global DNA methylation analysis and loci specific DNA methylation analysis using Pyrosequencing. Biomarkers for testing include LINE-1 repetitive sequence for global DNA methylation analysis, FMR1 promoter methylation, FOXP3 TSDR methylation, OCT4/NANOG methylation, cancer gene methylation panel, immunology methylation panels, and CNS disease panel.
- Custom assay design for validated GLP/GCP compliant studies.
- GLP/GCP compliant disease panel NGS sequencing and targeted gene bisulfite sequencing – coming soon.