# TOPIC 455: DEVELOPMENT OF A RAPID AT-HOME TEST TO DETECT PROSTATE-SPECIFIC ANTIGEN USING SELF-COLLECTED FINGER STICKBLOOD

> **NIH NIH N43** · INBIOS INTERNATIONAL, INC. · 2024 · $399,866

## Abstract

The goal of this Phase I SBIR project is to develop an at-home rapid test to detect elevated levels of prostatespecific antigen (PSA) in self-collected fingerstick blood samples from persons at risk of prostate cancer. Early detection would especially help African-American men, who have disproportionately high prostate cancer incidence and mortality rates and would benefit from early detection. PSA DetectTM will be a self-contained test kit that detects PSA levels >10 ng/ml of blood, provides a qualitative result without the use of instruments, and is suitable for self-testing at home. This lateral flow immunoassay will use proprietary InBios detection technologies that are used in FDA approved test kits for infectious diseases. The objectives are to: 1) optimize a PSA test prototype developed by collaborators at Cornell Weill
Medical, to meet the assay performance requirements; in parallel, produce a new panel of proprietary test
reagents and optimize additional functional test prototypes; 2) perform a prospective study to test three PSA
test prototypes in a home-like setting in men >40 years old, and select a single prototype for future clinical
evaluation based on functionality, operability and acceptability; and 3) begin drafting pre-submission
documents to seek regulatory guidance for 510(k) clearance for PSA Detect.

## Key facts

- **NIH application ID:** 11219742
- **Project number:** 75N91024C00078-0-9999-1
- **Recipient organization:** INBIOS INTERNATIONAL, INC.
- **Principal Investigator:** SYAMAL RATCHAUDHURI
- **Activity code:** N43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $399,866
- **Award type:** —
- **Project period:** 2024-09-16 → 2025-09-15

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11219742

## Citation

> US National Institutes of Health, RePORTER application 11219742, TOPIC 455: DEVELOPMENT OF A RAPID AT-HOME TEST TO DETECT PROSTATE-SPECIFIC ANTIGEN USING SELF-COLLECTED FINGER STICKBLOOD (75N91024C00078-0-9999-1). Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/grant/nih/11219742. Licensed CC0.

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