Synthesis and Characterization of a Rapidly Reprogrammable Fusion Protein for Detection of Pathogen Genomic Targets to Accelerate IVD Assay Development

NIAID is developing a novel, critical assay component that could be used by developers in their platform technologies to accomplish rapid reprogramming to a variety of infectious disease targets. This assay component will help NIAID protect the public's health by enabling the quick design and deployment of a new assay that targets a new pandemic potential viral pathogen. To realize this goal, this request is for performing the foundational proof-of-concept work to synthesize a custom engineered protein that will act as both a detector of the pathogen nucleic acid target, and a corresponding reporter of the detection signal with the switching on of an optical readout. Proving this switching ability of the critical assay component is essential to enable subsequent, additional developments by IVD developers into a fully configured assay. This in turn provides NIAID an IVD solution that is ready to be deployed with an emerging disease outbreak, and is flexible and agnostic to whatever the molecular target. The NIH team believes that successful completion of the proposed request work will establish a pathway to accelerate availability of an FDA regulated infectious disease diagnostic assay for an emerging disease outbreak. The component is designed with common elements for a myriad of disease targets, and thus facilitates performing the fundamental verification and validation studies that would be applicable for different analytes. This would help reduce regulatory hurdles, and attract smaller IVD developers that otherwise would be disadvantaged with insufficient resources but have the innovations that fit NIAID's mission. With the main risks mitigated through this request, assay developers would have less barriers for adoption and thus would be more inclined to partner in IVD development that would concurrently serve both their commercial interests and NIAID public health priorities. Approval of this request would lead to a diagnostic solution with broad accessibility, and thus enable meeting NIAID's public health mandate. If this request is not fulfilled, it could jeopardize NIAID's ability to rapidly respond to an emerging disease outbreak, whether natural or engineered, with an effective, accessible IVD solution.