Methylation biomarker development in the context of the EU regulations for clinical use of in-vitro diagnostic devices

Expert Rev Mol Diagn. 2019 Jun;19(6):439-441. doi: 10.1080/14737159.2019.1618188. Epub 2019 May 17.

Author

Tomasz K Wojdacz¹

Affiliation

¹ a Head of Clinical Epigenetics Laboratory , Pomeranian Medical University , Szczecin , Poland.

PMID: 31092067
DOI: 10.1080/14737159.2019.1618188

No abstract available

Keywords: Epigenetic; biomarker; in-vitro diagnostic; methylation.

Publication types

Research Support, Non-U.S. Gov't
Review

MeSH terms

Biomarkers*
DNA Methylation*
Disease Management
Early Diagnosis
Epigenesis, Genetic*
Epigenomics / instrumentation*
Epigenomics / legislation & jurisprudence
Epigenomics / methods*
Genetic Association Studies / instrumentation
Genetic Association Studies / methods
Genetic Predisposition to Disease
Humans
Medical Device Legislation
Molecular Diagnostic Techniques / instrumentation
Molecular Diagnostic Techniques / methods
Reagent Kits, Diagnostic*

Substances

Biomarkers
Reagent Kits, Diagnostic