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.
NIH/NCI 455

Topic

Point-of-Care Detection of Prostate Specific Antigen

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 Small Business Innovation Research (SBIR) contract proposals. The specific topic of the solicitation is "Point-of-Care Detection of Prostate Specific Antigen". The technology being solicited is the development of an accurate and inexpensive home test for prostate-specific antigen (PSA). Prostate cancer is a significant cause of cancer mortality, and PSA screening has been shown to reduce mortality rates. However, after a recommendation against screening in 2012, the mortality curve flattened and the incidence of metastatic disease increased. Therefore, the development of a home test for PSA has the potential to increase the detection of disease amenable to curative therapy or surveillance, particularly among high-risk populations such as African American men. The solicitation is open to Fast-Track proposals and will not accept Direct-to-Phase II proposals. The anticipated number of awards is 3-5, and the budget for Phase I is up to $400,000 for up to 12 months, while Phase II is up to $2,000,000 for up to 2 years. Proposals that exceed the budget or project duration may not be funded. This topic aligns with the Cancer Moonshot Blue Ribbon Panel recommendation to expand the use of proven cancer prevention and early detection strategies. The solicitation is closed, and more information can be found on the grants.gov website.

Description

Fast-Track proposals will be accepted. Direct-to-Phase II proposals will NOT be accepted. Number of anticipated awards: 3-5 Budget (total costs, per award): Phase I: up to $400,000 for up to 12 months Phase II: up to $2,000,000 for up to 2 years PROPOSALS THAT EXCEED THE BUDGET OR PROJECT DURATION LISTED ABOVE MAY NOT BE FUNDED. Page 79 Summary Among men, prostate cancer is the second leading cause of cancer mortality in the US and fifth worldwide. The largest, randomized clinical trial of prostate-specific antigen (PSA) screening (ERSPC) reported a 20% reduction in prostate cancer mortality at 16 years among screened men compared to an unscreened control group and a 30% reduction in the cumulative risk of metastases after a median follow-up of 12 years. In 1994, the FDA approved PSA testing to aid in the detection of prostate cancer. In the first 20 years following this approval, prostate cancer mortality decreased by 50%. However, after the 2012 United States Preventive Services Task Force (USPSTF) recommended against prostate cancer screening, the prostate cancer mortality curve flattened, and the incidence of metastatic disease increased. In 2018, the USPSTF recommended that men aged 55-69 years engage in shared decision-making with healthcare providers to consider the benefits and harms of PSA screening in the context of family history, race, comorbid medical conditions, values, and preferences. The National Comprehensive Cancer Network, American Urology Association, and the American Cancer Society recommend that men discuss the pros and cons of PSA screening with their healthcare provider, starting at age 40 to 55 years. The prostate cancer mortality rate is high among African American men, who face disproportionately greater barriers to health care services, including cancer screening, compared to the general population. Decision analysis models suggest that PSA-based screening may provide greater benefit to African American men. Therefore, greater adoption of PSA screening in African American and other high-risk men has the potential to reduce the burden of cancer treatment by increasing the detection of disease amenable to curative therapy (when indicated) or surveillance (when appropriate). The development of an accurate, inexpensive home test for PSA is both an unmet need and an NCI priority in the context of President Biden’s Moonshot goal of reducing cancer mortality by half within 25 years. While the availability of home or point-of-care testing cannot overcome structural impediments to screening, the knowledge that one has an elevated PSA would remove a substantial barrier to screening by helping men prioritize this issue. This topic is aligned with the Cancer Moonshot Blue Ribbon Panel recommendation to expand the use of proven cancer prevention and early detection strategies (G).