Partnerships for Advancing Development of Diagnostics for Infectious Diseases

The National Institute of Allergy and Infectious Diseases (NIAID) seeks to advance its mission by supporting partnerships between academic (or small business) investigators and one or more industrial partner(s) for translational development of a diagnostic test that has demonstrated proof-of-concept. Novel diagnostics are needed to implement treatment strategies, evaluate vaccines and identify infectious disease outbreaks, but too often, early diagnostic breakthroughs are not being translated into successful commercial products. Investigators often develop promising diagnostics but then face barriers when navigating the process towards commercialization. The goal is to align investigators with experienced industry partners early in the development process, to enable early de-risking and ensure that the end-product will be fit for purpose. A science advisory board together with NIAID oversight will help maintain the focus of projects. Annual meetings and workshops will foster collaborations and knowledge exchange with biotech/industry developers, and other investigators in the early diagnostic space. This partnership concept aligns with NIH’s mission to support the translation of the most promising diagnostic technologies to better treat and prevent infectious diseases. Grant authorities that allow NIAID to forecast this opportunity are as follows: Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 2 CFR Part 200.