A Solicitation of the National Institutes of Health (NIH) and The Centers for Disease Control and Prevention (CDC) for Small Business Innovation Research (SBIR) Contract Proposals

Active
No
Status
Closed
Release Date
August 25th, 2023
Open Date
August 25th, 2023
Due Date(s)
November 14th, 2023
Close Date
November 14th, 2023
Topic No.
CDC/NCEZID 031

Topic

Development of SHERLOCK Assay for Detection of High Threat Orthopoxviruses

Agency

Department of Health and Human ServicesNational Institutes of Health

Program

Type: SBIRPhase: BOTHYear: 2023

Summary

The Department of Health and Human Services, specifically the National Institutes of Health and the Centers for Disease Control and Prevention, is seeking proposals for the development of a SHERLOCK Assay for the detection of high threat orthopoxviruses. This solicitation is for Phase I SBIR proposals only, and Fast-Track proposals and Phase I clinical trials will not be accepted. The anticipated number of awards is 1. The budget for Phase I is up to $243,500 for a duration of up to 6 months, while Phase II has a budget of up to $1,927,828 and a duration of up to 2 years. Proposals that exceed the budget or project duration may not be funded. The purpose of this research is to develop a field-deployable diagnostic assay using non-overlapping reagents for the rapid detection of infection in outbreak or response settings. The assay should be able to detect Variola virus (VARV), the causative agent of smallpox, as well as monkeypox virus (MPXV), which is a growing global health threat. The SHERLOCK test should incorporate multi-pathogen panels and be adjustable to different levels of specificity based on oligonucleotide sequences. The technology should be capable of working with a variety of pathogens, and the assay design could include two targets, one specific for MPXV and another for non-MPXV pathogens. For more information and to submit a proposal, interested parties can visit the SBIR topic link provided. The open date for proposals is August 25, 2023, and the close date is November 14, 2023.

Description

Phase I SBIR proposals will be accepted. Fast-Track proposals will not be accepted. Phase I clinical trials will not be accepted. Number of anticipated awards: 1 Budget (total costs): Phase I up to $243,500 for up to 6 months; Phase II of up to $1,927,828 and a Phase II duration of up to 2 years. PROPOSALS THAT EXCEED THE BUDGET OR PROJECT DURATION LISTED ABOVE MAY NOT BE FUNDED. Background Point of care diagnostic assays in outbreak or response settings are crucial for rapid detection of infection and determining appropriate next steps (isolation, contact tracing, treatment, etc.). Additionally, it’s critical to develop new diagnostics to meet evolving public health needs as testing availability can be impacted by competition for limited reagents/consumables during an outbreak. The development of a unique field-deployable diagnostic assay using non-overlapping reagents will address both preparedness concerns to improve response in the event of a Variola virus (VARV- the causative agent of smallpox) bioterror event, as well as monkeypox virus (MPXV) which continues to be an expanding global health threat. The SHERLOCK (specific high-sensitivity enzymatic reporter unlocking) test will need to incorporate Page 130 multi-pathogen panels and be adjusted to various levels of specificity based on oligonucleotide sequences. These technologies have been documented to work with a variety of pathogens. Approaches for assay design could be two targets, one specific for MPXV and another for non-MPXV pathogens.