Epistem's extensive knowledge of epithelial biology has been translated into a unique hair biomarker platform. Epistem's plucked hair assay can be used to determine the effects of novel therapeutic agent exposure on protein and gene expression in hair, providing valuable preclinical proof of concept data.
Epistem has developed techniques for reliable and reproducible immunohistochemistry labelling of single plucked human hairs for a number of antigens and can develop protocols and quantification methods for other antigens of interest.
Epistem can source healthy donors for scalp hair sampling and determine intra- and inter-donor variability to ensure subsequent clinical studies are sufficiently powered. Confirmation of optimal storage duration for antigen stability can also be determined and used to inform clinical trial protocol.
Proof of Concept
Epistem's ex vivo culture method shows good reproducibility and can be used to generate proof of concept data prior to the application of the assay in the clinical phase. Hair is plucked, transferred to maintenance medium and exposed to the novel therapeutic agent.
Gene expression can be used to correlate the effect of therapeutic agent on target tissue with hairs sampled from preclinical models. Expression in plucked hair can also be correlated with known biomarkers in matched serum and plasma samples.
Using Epistem's ex vivo culture technique a comprehensive package of data can be provided. Immunohistochemistry, using either whole mount or longitudinal sectioning techniques, and ELISA can provide a direct measure of the effects of novel therapeutic agent on protein expression and site-specific phosphorylation.
Gene expression can be of particular advantage where the target or pathway is unknown. Profiles can be obtained from plucked hairs using Epistem's proprietary gene expression technologies. Small amounts of RNA are extracted from the hair bulb and gene expression levels are determined by either microarray or qRT-PCR analysis.