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. Greg Tsongalis, Professor of Pathology, Dartmouth-Hitchcock Medical Center
In this video interview Dr. Greg Tsongalis addresses sources of pre-analytic variability when processing formalin-fixed, paraffin-embedded (FFPE) samples in a pathology laboratory setting. By 'pre-analytic', he refers to the kinds of kits used for DNA extraction, and other factors that may have a significant impact on the quality of the results. He also discusses his work on clinical assay development for somatic mutation detection using NGS technology.