Abstract

Accelerate Assay Development and Commercialization Using Reference Materials

Ronald Vos, Business Development Manager, SensID

Assay development in clinical genomics is a demanding process especially when complying correctly to all rules and regulations. When assays are becoming even more complex, like in liquid biopsy, where multiplexing becomes the standard and low to ultra low AF frequencies are demanded, the task gets near impossible. Add IVD or FDA demands on top of that and the complexity is that of a giant puzzle with many different aspects. Obtaining the correct and the right amount of clinical samples while facing all these demands is where you can expect friction. For these reasons, there is an acceptance for “contrived” materials but how does it all work. What are the official guidelines?