Delivering Your New Diagnostic Test into a Clinical Laboratory

Just about any scientist would say that creating a novel and reproducible method that provides accurate, unambiguous results is a difficult path. Magnify the difficulty with the added task that the methodology needs to be used as a clinical laboratory diagnostic, and many would turn around and walk in the other direction. Thankfully, there are still those intrepid researchers who know they have developed something worthy of navigating the arduous and rapidly evolving regulatory landscape that could ultimately help save lives.

In this GEN webinar, our distinguished speaker, Dr. Donna Wolk, will describe “a day in the life” of a clinical laboratory scientist deploying new molecular diagnostic methods in a clinical laboratory setting. Dr. Wolk will deftly discuss the specifics of laboratory method verification, validation, and clinical laboratory quality systems and the common pitfalls that investigators face when implementing new molecular modalities—especially in the time of COVID-19.

A live Q&A session followed the presentation, offering a chance to pose questions to our expert panelist.