Wearable Diagnostic for Detection of COVID-19 Infection

Purpose

This solicitation, issued by MTEC, represents a Request for Project Proposals (RPP) for MTEC support of the U.S. Army Medical Research and Development Command (USAMRDC) Military Infectious Diseases Research Program (MIDRP) and Military Operational Medicine Research Program (MOMRP). Military relevance is a critical component of Enhanced White Paper submission. Strategic and tactical oversight for the award(s) supported by this RPP will be provided by the MIDRP and MOMRP.

The goal of this RPP is to develop a wearable diagnostic capability for the pre-/very early symptomatic detection of COVID-19 infection.

Note: Pending successful completion of this effort, the Government may issue a noncompetitive follow-on production contract or transaction pursuant to 10 USC 2371b section f.

Scope of Work

During the Period of Performance (PoP), the Awardee(s) will be expected to develop a working prototype and perform testing on clinically relevant human samples (known positive and negative) and compared to current gold standard. Specificity to detect COVID-19 infection or markers of current infection from asymptomatic or symptomatic patients should be demonstrated.

Current Institutional Review Board (IRB) approval is preferred at the time of Enhanced White Paper Submission. Awardee(s) will be required to obtain protocol approval from USAMRDC’s Human Research Protections Office (HRPO) at the start of the PoP. Offerors are required to bring forth access to data sets of utility to prediction of infection.

Offerors shall have a plan to obtain an Emergency Use Authorization (EUA) status from the U.S. Food and Drug Administration (FDA) within the first 45 days of the PoP if the product will be an FDA-regulated COVID diagnostic.

During the PoP, the Offeror is expected to file for clearance/approval by the FDA along the appropriate regulatory pathway (i.e., 510(k), de novo, etc.).

Points of Contact

For inquiries, please direct your correspondence to Biomedical Research Associate Chuck Hutti, Ph.D. at Chuck.Hutti@ati.org.