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U.S. National Institutes of Health
Cancer Diagnosis Program Cancer Imaging Program Cancer Therapy Evaluation Program Developmental Therapeutics Program Radiation Research Program Translational Research Program Biometric Research Branch Office of Cancer Complementary and Alternative Medicine

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 Poly(ADP-Ribose), ELISA Detection of PAR 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-AKT and
-ERK, ELISA (Coming Soon)		 Detection of phosphorylated AKT (Ser473) and ERK1(Thr202/Tyr204)-ERK2(Thr185/Tyr187) in needle tumor biopsies


Additional Resources

Please email any questions or comments to PDinfo@mail.nih.gov.