NIH/NCI 455 - Point-of-Care Detection of Prostate-Specific Antigen
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.
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).
Project Goals
The goal of this concept is to demonstrate analytic performance of a home PSA test at an appropriate price point (less than $20.00). The technology should be designed for ease of use at home, analogous to home COVID-19 testing, using a finger stick to obtain a blood sample. The risk-benefit ratio of PSA testing can be improved by raising the threshold for a positive test to a PSA > 10 ng/ml. This would reduce both the number of false positive tests and, more importantly, the detection of clinically insignificant cancers, the treatment of which represents pure harm. In addition, a qualitative test with a read-out of “less than 10 ng/ml or greater than 10 ng/ml” would greatly simplify the counseling process for men with positive tests in that fewer men will be called “positive.” In addition, there is general agreement that men with a confirmed PSA > 10 ng/ml and a life expectancy of 10 years should be referred for biopsy absent an obvious cause of transient PSA elevation, such as acute prostatitis.
Phase I Activities and Deliverables:
Offerors must propose to conduct activities that lead to development of a working prototype device ready for clinical evaluation, including but not limited to:
- Develop a working, point-of-care, diagnostic prototype, self-collection blood test using user-centric design principles.
- Demonstrate that the diagnostic assay can be operated as a self-test by men > 40-years old (target population).
- Conduct studies to evaluate and test user acceptability and feasibility.
- Conduct initial clinical testing with at least one of the current FDA-approved PSA assays to demonstrate accuracy of PSA measurement compared to a gold standard test.
- Offerors may need to establish a collaboration or partnership with a medical facility or research group in the US that can provide relevant positive control and patient samples.
- Offerors must provide a letter of support from the partnering organization(s) in the proposal.
Phase II Activities and Deliverables:
Offerors must propose activities leading to the manufacturing and regulatory approval of the device, including but not limited to:
- Develop a well-defined self-sampling device under good laboratory practices (GLP) and/or good manufacturing practices (GMP).
- Perform scale-up and production for multi-site evaluations (with at least one independent CLIA-certified laboratory) using clinical isolates.
- Demonstrate the operability of the test for use in non-clinical laboratory settings including at-home self-testing (with self-collection of the specimen) by the target population.
- Establish a strategy for FDA regulatory approval and insurance and/or CMS reimbursement.
- Develop educational materials for interpretation of the test results and when to seek medical guidance.
Receipt date: November 14, 2023, 5:00 p.m. Eastern Standard Time
Apply for this topic on the Contract Proposal Submission (eCPS) website.