Biomarker Testing

A biological marker (“biomarker”) is a characteristic that is objectively measured as an indicator of normal biologic processes, or pharmacological responses to a therapeutic intervention.   Historically, biomarkers have been used for diagnosis and staging disease, and as indicators of disease prognosis.  In drug development and clinical trials, biomarkers may be used to help identify populations for a study, monitor therapeutic response, and identify side effects.   You may order testing from our existing validated multiplexed panel or our expert scientists will configure and validate a custom multiplexed assay panel to meet your biomarker needs.


Available Assays:

Cytokines

Cytokines have been shown to be involved in autocrine, paracrine and endocrine signaling as immunomodulating agents.   Their definite distinction from hormones is still part of ongoing research.   Our multiplex immunoassay panel uses particle technology and flow cytometry to quantify protein and peptide analytes (i.e., IL-1α, IL-1β, IL-4, IL-6, IL-8, IL-10, TNF-α, and IFN-gamma) from a single 12.5 µL (minimum) human plasma sample.   Additionally, we have an ELISA (Enzyme-Linked Immunosorbent Assay) assay designed for the quantitative measurement of RANTES protein in human plasma.

Hormones

A hormone is any member of a class of signaling molecules in multicellular organisms, that are transported to distant organs to regulate physiology and behavior.   Our multiplex immunoassay panel also quantifies the human hormone BNP from a single 12.5 µL (minimum) human plasma sample.   BNP is a B-type natriuretic peptide produced by the heart.

Compliance

These assays are validated according to the FDA’s Bioanalytical Method Validation Guidance for Industry.

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