Table 1.

Examples of first-order biospecimen issues for new biomarkers

What is the intended use of the assay?
What is the clinical utility (how useful is the diagnostic for its intended clinical use)?
What additional information is required for an accurate test result?
What biomolecule or analyte is being analyzed?
What types of tissue/fluid will be used for analysis?
Does a clinical specification exist for this biospecimen?
Is this specification adequate for this test?
Have the specimens been serially tested to determine whether they are stable in storage?
Can the assay be replicated in another laboratory with the original specimens?
Can the assay be replicated in the original laboratory with submitted specimens?