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
Poster Titled “New Technical Approach to Construct ctDNA Materials for use in Characterizing, Developing and Validating Plasma Assays”, available for download
The Keystone Symposia is an organization with 44 years of history on specialized topics across the fields of molecular and cellular biology. This week in Banff, Alberta, Canada is a Keystone Symposia conference called The Cancer Genome, along with a joint meeting on Genomics and Personalized Medicine. Their Twitter description (@KeystoneSymp) describes the Keystone organization as “A catalyst for accelerating life science discovery and connecting scientists within and across disciplines at symposia worldwide”.
Interview with Dr. Seth Harkins, Principal R&D Scientist
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’.