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/NCHHSTP 057

Topic

Device for point-of-care nucleic acid purification and detection of HCV

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 (NIH) and The Centers for Disease Control and Prevention (CDC), are seeking proposals for a Small Business Innovation Research (SBIR) contract. The topic of the solicitation is a "Device for point-of-care nucleic acid purification and detection of HCV". The technology being solicited is a simple and inexpensive device that can perform nucleic acid extraction and detection workflows with minimal user intervention. This device would allow for the diagnosis of Hepatitis C virus (HCV) infection at the point of care, expanding access to HCV diagnostic testing. The potential impact of this technology is significant, as HCV infection is a major global health problem and a leading cause of cirrhosis and liver cancer. The World Health Organization (WHO) has established elimination goals for HCV infection, and achieving these goals will require expanding access to HCV testing. Currently, HCV diagnostic testing methods have high costs, slow turnaround times, and need to be performed in a laboratory, leading to access problems and potential loss of patients to follow-up care. The project duration for Phase I is up to 6 months, with a budget of up to $243,500. Phase II has a budget of up to $1,972,828 and a duration of up to 2 years. Only Phase I SBIR proposals will be accepted, and fast-track proposals and Phase I clinical trials will not be accepted. The anticipated number of awards is 1. Proposals that exceed the budget or project duration listed above may not be funded. More information about the solicitation can be found on the grants.gov website (link: https://www.sbir.gov/node/2451765) and the sam.gov website (link: https://sam.gov/opp/aa72581c848947f0b61c15062e604862/view). The solicitation was released on August 25, 2023, and the application due 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 $1,972,828 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 Hepatitis C virus (HCV) infection is a major global health problem and chronic HCV infection is a leading cause of cirrhosis and liver cancer. HCV infects an estimated 2.4 million people in the U.S. and 58 million people, globally. Effective and well-tolerated direct acting antiviral (DAA) drugs are available for the treatment of HCV infections and the World Health Organization (WHO) has established elimination goals of 90% reductions in the number of new HCV cases and 65% reductions in deaths associated with HCV infection by the year 2030. Achievement of these goals will require expanding access to HCV testing as only 20% of current infections have been globally diagnosed. Current HCV infections are diagnosed by the detection of either circulating HCV RNA or HCV core antigen in a person’s blood. HCV diagnostic testing methods often have high costs, slow turnaround times, and need to be performed in a laboratory, which lead to access problems and the potential to lose patients to health care provider follow up after a positive diagnosis. Ideally, HCV diagnosis would occur at the point of care while the patient waits, allowing for immediate linkage to care and treatment in people with HCV infections. Currently there are no point-of-care tests for the detection of HCV RNA available in the US. The development of a simple and inexpensive device that can perform nucleic acid extraction and detection workflows with minimal user intervention would allow for the diagnosis of HCV infection at the point of care, and greatly expand access to HCV diagnostic testing.