Banked-Specimen Retrospective Studies

Many marketing applications for in vitro diagnostics (IVDs) need to be supported by clinical data. This is especially likely for new analytes or new intended uses. In some instances, the only means to gather the requisite data is by conducting a prospective study. Sometimes, only freshly collected specimens can be used to generate the necessary data due to the nature of the disease or the assay. Moreover, collecting specimens prospectively gives the applicant the most control over the study design. The applicant, for example, can make sure the clinical specimens are collected in a manner that precisely matches the proposed intended use.

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