Development of a guideline for protein chip evaluation as medical devices

Protein chip technology can be applied to diagnosis of disease, prognosis, drug discovery, tailored drug therapy, screening of drug candidates and so on. A protein chip should be evaluated and approved as a medical device to be used as a diagnostic device before marketing. In this study, we prepared a cancer protein chip and evaluated it. From the results of this evaluation study, we developed the requirements and standards for protein chip evaluation as medical devices to guide how to prepare technical documents and what data should be submitted to verify the safety and effectiveness of a protein chip for industry and KFDA reviewer. The guideline was established with three areas; evaluation of quality control system, analytical, and clinical performance. First, quality control system should be evaluated in the aspect of material, manufacturing process, and final product. In addition, validation of expiration date and storing condition is needed to confirm the quality control system. Second, evaluation of analytical performance includes the validation of analytical sensitivity, reproducibility, specificity, and effectiveness of signal detecting instruments with related software. Third, clinical performance evaluation includes clinical sensitivity, specificity, and cut-off value. This guideline will be helpful for preparing and reviewing of diagnostic protein chip submission as medical devices and facilitating the commercialization of protein chips.