Validated Biomarker Assays
Validated Assays, Specimen Handling Procedures and Reagent Sources for Clinical Pharmacodynamic Studies and Training Certification.
|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.
|Immunoassays||γH2AX, ELISA (Coming Soon)||Detection of histone H2AX phosphorylated at Ser139 in needle tumor biopsies|
|Detection of phosphorylated ERK1(Thr202/Tyr204)-ERK2(Thr185/Tyr187) in needle tumor biopsies|
Please email any questions or comments to PDinfo@mail.nih.gov.
Other DCTD Resources
- DTP Reference Guide for New Users
- DTP Resources for NCI Intramural Researchers
- Drug Development Interactive Timeline