Addressing the Variability of Molecular Assays - Dr J Frampton

As molecular diagnostics takes a more central role in clinical decision making, diagnostics developers and clinical laboratories have raised awareness of the critical need for quality control through standardization of technologies and methods. Using precise gene-editing technology, Horizon Diagnostics has created a new generation of molecular reference standards. These are based on having a tightly defined allele burden and common genetic background. They are currently being used by more than 200 research laboratories across the world to understand the sensitivity of their molecular assays. The longer-term vision is to give clinicians the additional confidence in diagnosis and therapeutic decision making necessary to underpin personalized medicine and thereby to improve patient outcomes.