NOV 12, 2015 10:30 AM PST

Validation of Mass Spec Analytical Platforms and Proteomic Biomarkers: FDA perspective

  • Scientific Reviewer, Food and Drug Administration Center for Devices and Radiological Health
      Senior Staff Fellow, Office of In Vitro Diagnostics and Radiological Health, Food and Drug Administration Center for Devices and Radiological Health.
      I received a Bachelor of Science degree in biology from the Massachusetts Institute of Technology and a Ph.D. in biochemistry from the University of California, San Francisco. Before working at the FDA, I worked at the Novartis Institutes of Biomedical Research performing basic research in oncology target discovery.


    Basic research in Proteomics has led to new understanding of proteins’ contributions to health and disease, and has also driven the advancement of powerful analytical technologies used to explore these contributions.  Translating these discoveries and technologies into in vitro diagnostic (IVD) tests presents expanded opportunities to improve patient care; however, the complexity of these technologies raises challenging questions on how to evaluate the safety and effectiveness of these tests.  Fundamental to using IVDs in the clinic is the demonstration that the tests are safe and effective—that the results claimed are accurate and precise and that the clinical interpretation of the results is supported by science.  The more complex the information gathered, the more challenging is the validation of results; therefore,  FDA will discuss the elements of clinical and analytical validation of IVDs and proteomic technologies the successful transfer of research and discovery-level assays into the clinic.

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