# HLS-Affordable, quantitative microchip-electrophoresis for sickle cell disease screening

> **NIH NIH R44** · HEMEX HEALTH, INC. · 2020 · $750,000

## Abstract

PROJECT SUMMARY
Sickle Cell Disease (SCD) affects 100,000 Americans and more than 14 million people globally,
primarily in economically disadvantaged populations. It is estimated that nearly 50-90% of children
born with SCD in these areas die before the age of five, although 70% could be saved through
simple, cost-effective treatments if diagnosed early according to World Health Organization. Early
diagnosis of SCD remains a challenge in the developing world due to requirements for
sophisticated lab equipment and skilled personnel; therefore, an affordable, accurate point-of-
care (POC) diagnostic is needed. Our device (“HemeChip”) provides the performance of a
laboratory test in a product that is portable, affordable, rapid, and easy-to-use. “HemeChip” is a
miniaturized version of the standard test used in SCD screening, known as cellulose acetate
hemoglobin electrophoresis, which can identify SCD with high sensitivity and specificity, as well
as identify and quantify the most common hemoglobin types – a feature that enables a more
accurate diagnosis. The objective of this SBIR Phase I/II Fast-Track project is to translate
HemeChip technology into a POC platform for diagnosing hemoglobin disorders, specifically
SCD. In Phase I, we propose to demonstrate hemoglobin variant identification and quantification
performance against quantitiative capillary electrophoresis and/or high performance liquid
chromatography, which are considered to be the gold standard tests. Our Phase II aims and
milestones focus on activities required for commercialization: single-use cartridge (finger/heel-
stick) development, design validation and clinical testing, which will position the technology for
regulatory filings. Our goal is to ensure that HemeChip technology addresses the requirements
for a low-cost, easy-to-use, POC screening platform for SCD in low-income and under-resourced
environments. Our proposed device will address a major gap in regions where universal sickle
cell screening programs are missing or ineffective in reaching remote areas. The portable design,
affordability, rapid and accurate testing makes it practical, for the first time, to effectively screen
large numbers of people with sickle cell disease and other hemoglobin variants in Africa and India.

## Key facts

- **NIH application ID:** 9913568
- **Project number:** 5R44HL140739-03
- **Recipient organization:** HEMEX HEALTH, INC.
- **Principal Investigator:** PETER GALEN
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $750,000
- **Award type:** 5
- **Project period:** 2019-04-12 → 2022-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9913568

## Citation

> US National Institutes of Health, RePORTER application 9913568, HLS-Affordable, quantitative microchip-electrophoresis for sickle cell disease screening (5R44HL140739-03). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/9913568. Licensed CC0.

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