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Last Updated: 10/11/2017


Validated Biomarker Assays

Validated Assays, Specimen Handling Procedures and Reagent Sources for Clinical Pharmacodynamic Studies and Training Certification.

Method Target(s), Platform Description
Circulating Tumor Cells Antibody Qualification
and CTC Enumeration, CellSearch System
Detection of PD biomarkers in CTCs using the CellSearch System.
Immunoassays Apoptosis Multiplex Biopsy Extraction Method, Luminex Tumor biopsy fractionation method for the Apoptosis Multiplex Immunoassay Panels.
Hypoxia Inducible Factor 1-alpha, ELISA Detection of HIF1 alpha in needle tumor biopsies.
MET Immunoassays, ELISA Detection of Intact MET, Dual Phospho-Y1234/Y1235 MET, Phospho-Y1356 MET in needle tumor biopsies.
Poly(ADP-Ribose), ELISA Detection of PAR in needle tumor biopsies and PBMCs.
Total Topoisomerase I, ELISA Detection of Top1 in needle tumor biopsies and PBMCs.
Immunofluorescence Assay γH2AX, Bond-Max Detection of histone H2AX phosphorylated at Ser139 in paraffin-embedded tumor biopsies using the Bond-Max System.

Research-Use-Only Biomarker Assays

Unlike the DCTD validated biomarker assays listed above, research-use-only (RUO) assays have not been transferred to a secondary laboratory, nor have they been assessed via clinical performance standards. These RUO procedures do not have a formal training program or qualified reagent supply, however phone consultation may be requested.

Method Target(s), Platform Description
Immunoassays γH2AX and Total H2AX, ELISA Detection of histone H2AX phosphorylated at Ser139 and Total H2AX in tumor biopsies and lysates of cultured cells or PBMCs.

Additional Resources

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