Development of open-access mock 510(k) regulatory documents on multiplex proteomic technologies.

Abstract

99 Background: Proteome-based biomarker science is progressing slowly for a variety of factors, including a lack of dialogue early in the discovery/development process with regulatory agencies such as the Food and Drug Administration (FDA). Although high-throughput multiplex proteomic-based technologies have the potential to accurately measure proteins of clinical significance in complex human matrices, regulatory approval for these analytical technologies have not been explored. Methods: To address this gap, investigators from the National Cancer Institute’s Clinical Proteomic Tumor Analysis Consortium (CPTAC) held a forward-thinking workshop, involving clinical laboratories, instrument manufacturers, researchers, and FDA representatives in order to streamline the regulatory approval of protein-based multiplex platforms. Results: Outcomes included a peer-reviewed workshop report published in special proteomics issue of Clinical Chemistry, and first-of-its-kind open access mock 510(k) regulatory documents (based on two most commonly applied quantitative proteomic technologies: multiplex mass spectrometry-based and multiplex affinity-based platforms) as public community resources (also published in Clinical Chemistry). Conclusions: These open-access documents provide a glimpse of the FDA’s perspective of novel approaches to in vitro diagnostics of multiplex protein assays and the process of premarket review. Therefore, these resources should enable others to focus on aspects of the process carefully monitored by the FDA, observe a format that is acceptable to the agency, and understand the iterative nature of review.