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: 1-2
Budget (total costs): Phase I: up to $243,500 for up to 6 months; Phase II of up to $1,000,000 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
Wastewater surveillance provides a powerful independent approach to complement existing surveillance systems. Wastewater
surveillance is currently being used to support the COVID-19 response. SARS-CoV-2 RNA is shed in the feces of individuals with
both symptomatic and asymptomatic infections and SARS-CoV-2 RNA in wastewater has been demonstrated to be a leading
indicator of reported cases and hospitalizations. There is no evidence to date that anyone has become sick with COVID-19 because
of exposure to wastewater, but wastewater is a hazardous material and molecular analyses of samples that could potentially contain
multiple human pathogens are severely restricted. This results in significant barriers for laboratories onboarding testing and there is a
need for a product or procedure to provide molecular preservation (stabilization) and pathogen inactivation from post-sampling of
wastewater to help overcome these barriers. Project Goals
The goal of the proposed research is to develop a product to inactivate and stabilize wastewater samples for shipping and transport.
This product must be amenable to on-site use by stakeholders, such as State Agencies for wastewater monitoring, etc., and could be
physical or chemical inactivation. The product can be an all-encompassing portable sampler that inactivates and provides molecular
preservation of pathogens in wastewater or be used sequentially with existing samplers without adding additional biosafety risks to
the collection procedure. The product will provide a qualitative indicator that the inactivation process has occurred, and the
inactivation of the wastewater sample must not interfere with downstream molecular testing. Phase I Activities and Expected
Deliverables
The expected deliverables are:
1. Develop or adapt a method to inactivate and molecularly preserve SARS-CoV-2, or the proxy virus controls, bovine
coronavirus (BCoV), murine coronavirus (MCoV, e.g., murine hepatitis virus), bacteriophage Phi6, or human
coronavirus OC43, in wastewater samples; the method must be able to provide an indicator that the inactivation
process has occurred.
2. Quantify molecular detection before and after the molecular preservation and inactivation procedure for SARSCoV-2, or the proxy virus controls bovine coronavirus (BCoV), murine coronavirus (MCoV, e.g., murine hepatitis
virus), bacteriophage Phi6, or human coronavirus OC43, in wastewater samples. Method development with
surrogate viruses will be considered but final evaluation with SARS-CoV-2 must be included.
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3. Conduct matrix evaluation to understand the assay performance using different wastewater types (e.g., raw
wastewater, sludge).
Impact
The product of this proposed research will allow laboratories to test and monitor their wastewater supplies for SARS-CoV-2 and
other emerging pathogens without the need for dedicated containment laboratories, which is currently not possible. Once safe
processing is available, laboratory capacity can scale up and expand to other pathogens that pose a public health threat and thereby
inform control processes and ultimately reduce the burden of infections.
Commercialization Potential
This research will lead to the development of new products that inactivate infectious material in wastewater samples and provide
molecular preservation to benefit stakeholders at every point in the wastewater surveillance process from collection to testing.
Potential products include inactivation and stabilization systems, inactivation indicator kits, storage and transport products, and
wastewater sampling devices that provide an all-in-one “sample collection-to-inactivated and stabilized infectious material”
transport sample container. These products could be used by water managers, universities, businesses, correctional facilities, and
healthcare facilities, as well as federal, state, and local public and environmental health agencies. The market for products for
wastewater surveillance sample collection and testing has grown exponentially during the COVID-19 pandemic and is likely to
continue to grow as public health departments establish longer-term wastewater-based disease surveillance programs for SARSCoV-2 and other disease targets.
