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Clinical Pharmacodynamic Biomarker Assays

The Division of Cancer Treatment and Diagnosis (DCTD) Clinical Pharmacodynamic Program (CPP) has developed biomarker assays that are intended to investigate drug and downstream drug-induced effects. The CPP uses quality-controlled reagents, standards, and controls to develop the assays. It develops SOPs for the assays and specimen handling to ensure inter-operator, inter-run, and inter-site reproducibility. Rigorous methodologies and reference materials result in accurate and reproducible evaluation of drug effect in heterogeneous clinical specimens.

  • NCLN-Supported Validated Biomarker Assays

    The National Clinical Laboratory Network (NCLN) offers validated, harmonized SOPs while implementing uniform assay workflow, instrumentation, and data analysis across network laboratories. Approved NCLN assays will be performed at the NCI’s expense, with no need to identify a funding source.

  • Additional Supported Validated Biomarker Assays

    DCTD provides training and key reagent support to the cancer research community for these additional supported validated biomarker assays. For more information, contact PDinfo@mail.nih.gov.

  • Historical Biomarker Assays

    Historical biomarker assays were developed by the DCTD Pharmacodynamic Biomarkers Program. Unlike the validated biomarker assays listed above, these additional published assays do not have a formal training program or a qualified reagent supply; however, consultation may be requested.

  • SOPs for Specimen Collection

    The following specimen collection SOPs were developed by DCTD to standardize the methods for collecting and handling frozen needle biopsies and blood specimens for use in measurement of pharmacodynamic markers following treatment with anticancer agents.

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