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June 15, 2009 (Vol. 29, No. 12)

Banked-Specimen Retrospective Studies

A Clinical Validation Shortcut or a Lengthy Detour?

  • 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 ...

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