A Commercialization Pathway for RAPID 1.0 – A Novel Diagnostic Platform

Abstract

The COVID-19 pandemic has revealed infrastructure issues already present in diagnostic testing. Diagnostics remain costly and largely inaccessible to large segments of the American public. Increased innovation in this industry is a must to provide a new age of at-home, low-cost diagnostic technology options. The de la Fuente Lab at the University of Pennsylvania has created a low-cost and highly accurate diagnostic platform using novel electrochemical detection methodologies. This thesis provides a commercialization plan for Professor de la Fuente’s breakthrough approach to diagnostic testing. I detail a path to market for the technology’s first target for COVID-19 and a plan to extend this technology to other diseases. This begins with a strategy for a series of scientific validation studies that are required for FDA approval for the SARS-CoV-2 diagnostic. Further regulatory strategy is offered to adapt the platform to bacterial STDs, the first diagnostics to be created from this platform technology after the pandemic, along with a business plan to reach these markets both domestically and internationally. A development plan is clearly outlined to provide the estimated costs for each milestone of development, along with strategic partnerships to most quickly bring this device to market.