# Rapid Breast Cancer Diagnosis in Low and Middle Income Countries

> **NIH NIH R43** · AIKILI BIOSYSTEMS INC. · 2021 · $400,000

## Abstract

One of the biggest cancer challenges in low- and middle-income countries (LMICs) is the lack of access to
accurate and affordable cellular and molecular diagnostics, which are essential for making informed
therapeutic decisions, in particular for breast cancer. With the increased use of low cost ultrasound, it has
become possible to readily sample suspicious breast lesions with fine needles (fine needle aspirates, FNA).
However, the workup of such specimens is often impossible in many LMIC settings. To address these barriers
to diagnosis, Aikili—derived from A.I. and Akili (intelligence in Kiswahili)—seeks to enable the same-day
diagnosis of breast cancer at the point-of-care using a low-cost, automated system. The Aikili system is a
highly advanced stand-alone diagnostic platform capable of automated cancer diagnosis and receptor sub-
typing in near real-time (< 1 hour), at a low cost (<$800 for integrated hardware and $5-10 per test). Building
upon our initial development and successful clinical validation of human samples, the goal of this Phase I
application is to advance the Aikili technology to significantly improve its usability in resource-limited settings.
Specifically, we propose to i) upgrade Aikili technology by incorporating a custom-designed disposable
cartridge for onsite sample processing and deep learning algorithms for automatic analysis (Aim 1), and ii)
evaluate the performance of the upgraded system in LMIC workflows through a validation study in Kenya (n =
30) (Aim 2). We will consider the Phase I project successful when we can show that the field-optimized Aikili
system accurately and reliably detects breast cancer and receptor status in human FNAs compared to
accepted gold standards. Successful completion of Phase I would lead to a Phase II application for scale-up of
manufacturing and a larger, multi-site clinical validation study. This platform may alter therapeutic paradigms
for breast cancer patients in globally and enable appropriate use of chemotherapies and anti-estrogens in
limited supply.

## Key facts

- **NIH application ID:** 10154237
- **Project number:** 1R43CA257694-01
- **Recipient organization:** AIKILI BIOSYSTEMS INC.
- **Principal Investigator:** Laura E Kelley
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $400,000
- **Award type:** 1
- **Project period:** 2021-03-01 → 2024-02-29

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10154237

## Citation

> US National Institutes of Health, RePORTER application 10154237, Rapid Breast Cancer Diagnosis in Low and Middle Income Countries (1R43CA257694-01). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10154237. Licensed CC0.

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