# Smartphone Enabled Point-of-Care Detection of Serum Markers of Liver Cancer

> **NIH NIH UH3** · DUKE UNIVERSITY · 2020 · $721,330

## Abstract

ABSTRACT
Hepatocellular cancer (HCC) is the sixth most common cancer worldwide, and is highly prevalent in low- and
middle-income countries (LMIC). China alone accounts for >50% of HCC diagnoses. Surgical removal is the
primary and only curative option, yet only 30-40% of newly diagnosed patients are candidates for such
treatment. This is because the development of HCC is usually silent and diagnosis occurs relatively late,
when the disease has either metastasized or grown too large for surgical removal. Therefore, early diagnosis
is the key to achieving positive clinical outcomes, as removal at early-stage —when the tumor is small and
not metastatic— would result in a marked increase in cures in affected patients. Motivated by this hypothesis,
the objective of this proposal is to develop a blood-based point-of-care test (POCT) for hepatocellular cancer
(HCC). The POCT we have developed, the “D4 POCT”, is ideally suited for blood-based testing in LMIC
settings. The D4 POCT uses polymer brush-coated antibody (Ab) microarrays that have virtually no
background binding, yields quantitative results, and achieves picomolar sensitivity within 30 minutes. All
reagents are inkjet-printed and stored on D4 POCT cassettes, which do not require refrigeration. Upon direct
application of fingerstick blood onto a cassette, analyte capture and detection occur automatically, generating
a quantifiable signal obtained by placing the cassette in a small device that magnetically attaches to a smart
phone, which images and analyzes microarrays via on-board App. We will develop a multiplexed D4 POCT
capable of simultaneously detecting alpha-fetoprotein (AFP), dickkopf-1 (DKK-1) and osteopontin (OPN) that
will provide high sensitivity and specificity for HCC diagnosis. Our choice of markers is based on recent clinical
evidence showing that the simultaneous measurement of AFP, DKK-1, and OPN as a multiplexed panel
provides a promising strategy for early and accurate diagnosis of HCC. The innovation of this proposal is
the first complete bottom-up redesign in decades of the “gold standard” clinical diagnostic—the sandwich
immunoassay—as a self-contained point-of-care microarray assay that can be imaged and interrogated by a
smart phone. This project will be carried out by a consortium of investigators from Duke University, Zhejiang
Provincial People's hospital and our industry partner, Immucor, a leading diagnostics company that has
acquired the rights to this technology. After initial validation of the D4 POCT at Duke by meeting specific
performance milestones, we will demonstrate technical functionality and clinical potential for use in LMIC
settings at the Zhejiang Provincial People's hospital in Guangzhou China using patient-derived finger-stick
blood samples. The impact of this project is broad: beyond a new, low-cost, and clinically validated
technology for the point-of-care diagnosis of HCC, this diagnostic technology can be utilized to target any
analyte for which ...

## Key facts

- **NIH application ID:** 9972870
- **Project number:** 5UH3CA211232-04
- **Recipient organization:** DUKE UNIVERSITY
- **Principal Investigator:** Nelson J. Chao
- **Activity code:** UH3 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $721,330
- **Award type:** 5
- **Project period:** 2017-06-01 → 2022-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9972870

## Citation

> US National Institutes of Health, RePORTER application 9972870, Smartphone Enabled Point-of-Care Detection of Serum Markers of Liver Cancer (5UH3CA211232-04). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9972870. Licensed CC0.

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