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

> **NIH NIH N43** · INTELLIGENT OPTICAL SYSTEMS, INC. · 2024 · $382,537

## Abstract

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 >10 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.

## Key facts

- **NIH application ID:** 11219740
- **Project number:** 75N91024C00063-0-9999-1
- **Recipient organization:** INTELLIGENT OPTICAL SYSTEMS, INC.
- **Principal Investigator:** TRONG NGUYEN
- **Activity code:** N43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $382,537
- **Award type:** —
- **Project period:** 2024-09-16 → 2025-09-15

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11219740

## Citation

> US National Institutes of Health, RePORTER application 11219740, TOPIC 455: FINGERSTICK BLOOD TEST FOR POINT-OF-CARE DETECTION OF PROSTATE SPECIFIC ANTIGEN (75N91024C00063-0-9999-1). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/11219740. Licensed CC0.

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