TOPIC 455: FINGERSTICK BLOOD TEST FOR POINT-OF-CARE DETECTION OF PROSTATE SPECIFIC ANTIGEN

Prostate cancer ranks second in the US and fifth globally for male cancer-related mortality. This project seeks to combat high prostate cancer fatalities by developing an affordable at-home prostate-specific antigen (PSA) test that will enable self-monitoring of PSA levels, facilitating early intervention or surveillance. Leveraging our advanced enhanced lateral flow assay platform, IOS proposes an innovative home PSA test integrating sampling and testing in a single easy-to-use device. The test adopts a rt10 ng/mL PSA threshold to reduce false positives and provide binary results for simplified counseling. A smartphone app quantifies test strip data, eliminating the need for an external reader and reducing costs. Phase I will develop a functional prototype, demonstrating self-testing, acceptability, and feasibility. Preliminary clinical validation will compare results from 50 paired whole blood and serum clinical samples to an FDA-approved lab-based assay; 150 additional paired clinical samples with varying PSA levels will assess precision, detection limit, linearity, sensitivity, and specificity. FDA Pre-submission in Phase I will determine regulatory pathways. Phase II includes product maturation, pilot manufacturing, clinical validation, and regulatory approval. This cost-effective home PSA test addresses an unmet need, aligning with the NCI's cancer mortality reduction goal, and empowering men to proactively manage their health.