Development of a Nanosensor: Journey from a Lab Bench to an FDA Clearance and Beyond

S. Marla
Nanosphere, US

Keywords: nanoparticles


Nanosphere, Inc. was founded on the promise of using uniquely functionalized gold nanoparticle probes in the development of high-value molecular diagnostic tests. This presentation will chart Nanosphere’s decade-long effort toward the development of the Verigene System, an advanced molecular diagnostics platform. Today this fully-automated, sample-to-result system runs several FDA-cleared in vitro diagnostic tests and the company has a robust pipeline of future offerings. Key decisions, including target area selection, device format choices, manufacturing paths, choice of regulatory routes, and their respective outcomes will be highlighted.