ABSTRACT
A testing device for the identification of the molecular or heritable targets is used for all the above-mentioned trials. Owing to the importance and consequence of the diagnostic results, which predict response to the treatment of trastuzumab, the devices for identification of over-expression of HER2 protein or amplification of HER2 gene are designated as Class III devices, which require clinical trials by the premarket application (PMA). On the other hand, the MammaPrint is only for breast-cancer prognosis, and is not intended for diagnosis, prediction, or detection of responses to therapy or to help select the optimal therapy (Decision Summary k0762694; FDA, 2007e). It is designated as a Class II device under regulation 510(k) of premarket notification. Other characteristics of the diagnostic devices for the molecular targets are that they are heritable markers or multiple markers investigated simultaneously (multiplex tests). Success of translational medicine (TM) depends on the accuracy and quality of the assays for the molecular targets. To meet the different requirements of sensitivity, specificity, and quality for validation of diagnostic devices used in the TM and targeted clinical trials, the U.S. Food and Drug Administration (FDA) recently issued several important guidances or draft guidance. These guidances include
Guidance on Gene Expression Profiling Test System for Breast Cancer Prognosis (May 9, 2007; FDA, 2007a).
