Development of SHERLOCK Assay for Detection of High Threat Orthopoxviruses

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.