Presentations largely reflected negatively on the utility of PD-L1 for stratifying response, but pivotal new data on tumor mutational burden as assessed by Foundation Medicine's genomic sequencing panel.
This case study shows how the University Medical Center (UMC) Utrecht Genetics Department built a foundation to efficiently transition to whole genome sequencing with combined CNV and SNV analysis on the same data set.
The foundry model is poised to fundamentally transform the biotechnology sector. As it revolutionized the semiconductor industry in the mid 1980’s, the foundry model brings to molecular diagnostic companies a method to leverage the commonality of manufacturing techniques. By joining common manufacturing processes across several companies, assay manufacturing becomes a variable cost versus a fixed cost with substantial benefits to assay developers.
With increased biomarker and specialty lab data being incorporated into FDA submissions, drug developers are running into challenges as they prepare data that comply with new regulatory requirements. Precision for Medicine's experts present a case study for addressing these challenges and provide a solution.