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Biomarker Identification, Validation & Screening

Epistem's GCLP Compliant Platform for Hair Biomarker Analysis

Epistem's highly sensitive and GCLP compliant platform is suitable for the analysis of hair collected during clinical studies, whether for market approval or post-marketing for patient stratification. Hair is an ideal surrogate tissue as it is easy to sample, has good patient compliance and few ethical issues.

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Plucked Hair Sampling: A Simple and Ethical Method for Hair Collection

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.

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.

Epistem has conducted GCLP accredited clinical studies in support of drug development pipelines for a number of major pharmaceutical customers. Hair is an ideal surrogate tissue as it is easy to sample, has good patient compliance and few ethical issues.

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.

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