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Last Updated: 07/22/2015


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. Community-provided antibody qualification workflow packages.
Immunoassays Hypoxia Inducible Factor 1-alpha, ELISA Detection of HIF1 alpha 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 do they have a defined QA/QC plan, qualified supply chain, or defined clinical sample handling SOPs. These assays have not been evaluated for clinical performance. No training is provided for the use of the RUO SOPs, but phone consultation can be requested.

Method Target(s), Platform Description
Immunoassays γH2AX, ELISA (Coming Soon) Detection of histone H2AX phosphorylated at Ser139 in needle tumor biopsies
  Phospho-ERK, ELISA
(Coming Soon)
Detection of phosphorylated ERK1(Thr202/Tyr204)-ERK2(Thr185/Tyr187) in needle tumor biopsies

Additional Resources

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