The presentations during the FDA-AACR Liquid Biopsies in Oncology Drug and Device Development Workshop on July 19, 2016 included several important pieces of information that will likely guide the development of assays and their review by the FDA.
Important information for assay development and review by the FDA
How can you measure something without a ruler?
The science of metrology is tightly coupled with biological science, in tandem with biology becoming less descriptive and more quantitative over the past half-century. The US National Institute of Standards and Technology (NIST), an agency of the US Department of Commerce, has been established to ‘promote U.S. innovation and industrial competitiveness by advancing measurement science, standards and technology in ways that enhance economic security and improve our quality of life’.
In 2011, the National Academy of Science published the results of a year-long committee effort called ‘Toward Precision Medicine: Building a Knowledge Network for Biomedical Research and a New Taxonomy of Disease’. This committee was charged to explore the feasibility and need to develop a new taxonomy of human disease based upon molecular biology, with the concept that with an explosion of molecular data about individuals with disease, there was a great untapped opportunity to use these data to improve health.
FLICKR, JOHN GOODE