A Rapid, Accurate, Disposable Molecular Diagnostic to Detect Influenza and Emerging Infectious Disease, SARS-CoV-2

The overall objective of this contract is to advance the development of a multiplexed, single-use molecular diagnostic test that detects Flu A, Flu B, and SARS-CoV-2 viral RNA from a single nasal swab. The scope of work for this contract includes non-clinical, clinical, CMC, and regulatory activities necessary to take this multiplexed Respiratory Health test through FDA EUA for use in point of care (POC) settings. The assay will be implemented on the Contractor’s Version B platform, which is the lowcost, scalable platform suitable for automated manufacturing. Options are included to take the multiplexed Respiratory Test through to EUA-Over the Counter (OTC), 510k/CLIA-waiver and OTC approvals. Additionally, another Option is included to take the Contractor’s COVID-19 test implemented on the Version B platform through to EUA-OTC. Additionally, the Contractor will complete projects designed to reduce the cost of goods (COGs) such as assessing cheaper Reverse Transcriptase and DNA polymerase enzymes, and value-based engineering on the printed circuit board, plastics, and packaging. Moreover, the Contractor will develop digital assets (Electronic Health Record (EHR) integration and web-based patient portal) to complement the Contractor’s respiratory device and is designed to integrate seamlessly with patient EHRs in point of care settings.