# Breast Cancer Diagnostic Kit to Improve Early Diagnosis in Uganda

> **NIH NIH U01** · VANDERBILT UNIVERSITY MEDICAL CENTER · 2024 · $728,460

## Abstract

ABSTRACT:
Breast cancer in Uganda presents a pressing public health challenge, characterized by late-stage
diagnoses and high mortality rates, particularly among women residing in rural and semi-urban areas. This
proposal addresses this critical issue by optimizing, validating, and deploying a point-of-care diagnostic kit,
tailored for primary care clinics in Uganda, where most women access care. The proposed diagnostic kit
combines (1) an FDA-cleared automated AI-enabled whole breast ultrasound and (2) a smartphone-
enabled AI-powered device that performs brightfield imaging of basic cytology preparations and
incorporates a self-contained immunodiagnostic chip to quantify breast tumor biomarkers. Our approach
involves a two-fold validation strategy. First, we will validate the diagnostic performance of the proposed
diagnostic kit in a U.S. clinical setting, comparing it to standard-of-care methods such as ultrasound,
mammography, tissue sampling, and pathology (aim 1). Utilizing quality improvement cycles and feedback
from end-users, we will refine the kit's performance and usability. Next, we will validate the kit at the
Uganda Cancer Institute, tailoring it to Uganda's healthcare landscape, considering factors like
infrastructure, health workers’ expertise, and accessibility (aim 2). Following validation, and guided by a
Ugandan Community Advisory Board, we will implement a cluster randomized controlled trial involving
eight community health centers (CHCs) across two health districts in Uganda (aim 3). A mobile breast
cancer detection clinic will deliver the diagnostic kit to CHCs during bi-monthly Breast Health Days for
N=1000 patients referred for diagnostic evaluation, at 4 CHCs. We will compare the effectiveness of the
diagnostic kit with women receiving care at control CHCs, who will be referred for standard-of-care
ultrasound at Regional Hospitals (N=1000). Our collaboration draws upon expertise in engineering and
biomedical device development, breast cancer research, and global health, positioning us to significantly
impact breast cancer outcomes in Uganda. This initiative aligns with the RFA-CA-24-005 mission to
develop cancer-relevant technologies suitable for use in low- and middle-income countries. By validating
and deploying a practical, cost-effective, and user-friendly detection and diagnostic technology, we aim to
empower healthcare providers in Uganda and, ultimately, improve patient outcomes. If successful, this
innovation stands to enhance access to timely breast cancer detection and diagnosis in resource-
constrained settings.

## Key facts

- **NIH application ID:** 10949739
- **Project number:** 1U01CA292550-01
- **Recipient organization:** VANDERBILT UNIVERSITY MEDICAL CENTER
- **Principal Investigator:** Nixon Niyonzima
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $728,460
- **Award type:** 1
- **Project period:** 2024-08-26 → 2029-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10949739

## Citation

> US National Institutes of Health, RePORTER application 10949739, Breast Cancer Diagnostic Kit to Improve Early Diagnosis in Uganda (1U01CA292550-01). Retrieved via AI Analytics 2026-09-07 from https://api.ai-analytics.org/grant/nih/10949739. Licensed CC0.

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