# Novel Point-of-Care Device for Urinary Hepcidin to Detect Iron Deficiency in Children and Adolescents

> **NIH NIH R44** · INTRINSIC LIFESCIENCES, LLC · 2023 · $788,664

## Abstract

Summary/Abstract
 Iron deficiency (ID) is a leading cause of anemia worldwide and affects more than 17
million children in the US alone. However, it is now recognized the even without anemia, ID
adversely affects cognitive development, endocrine function, and physical and behavioral
growth and development in children. While anemia in the US is prevalent in 3.4% of children
ages 0.5-4 years old, the prevalence of non-anemic ID is much greater, estimated to be 15.1%
in children from 12-23 months and 16.5% from 2-5 years. Ideally, a non-invasive point-of-care
(POC) device to confidently diagnose ID would be of great interest to pediatricians. Hepcidin-25
has been shown to be the principal regulator of systemic iron homeostasis. Measurement of
serum hepcidin is a reliable marker for assessment of iron status and can prove a valuable
indicator of physiologic ID in adults and children. Urinary hepcidin is strongly correlated with
serum hepcidin and would serve as an excellent marker to diagnose ID in children and
adolescents employing the non-invasive POC device that we propose to commercialize.
 Intrinsic LifeSciences (ILS) is requesting Direct to Phase II funding to continue
commercialization of a multiplexed POC lateral flow assay (LFA) to quantify urinary hepcidin
normalized to urinary creatinine. We have successfully completed proof of principle research
resulting in a working prototype of the LFA. To achieve this milestone, ILS contracted with a
local San Diego company, NanoComposix (NCX), to utilize their ultra-bright gold nanoshell
technology to dramatically enhance diagnostic sensitivity. Reader selection will be a critical next
step in the commercial development of this device. End user design input will assist in selecting
a suitable strip reader followed by optimization of lateral flow strip geometry for deployment in a
cassette compatible with the selected reader. The hepcidin and creatinine assays will be
multiplexed on a single strip, further optimization for sensitivity and precision will be undertaken
and validation of the POC device will follow FDA industry guidelines for bioanalytical method
validation. Our pediatric clinical collaborators will beta test the LFA POC prototype device in a
research capacity to assess design control suitability before large scale manufacturing.
Concurrently, ILS will procure matched serum and urine samples and perform receiver operator
characteristic curve analysis to assess the diagnostic strength of the POC prototype device to
predict ID. During pre-commercialization Phase IIB follow-on funding, the device would be
tested in a multi-center clinical trial and the results submitted to the FDA for 510(k) clearance.

## Key facts

- **NIH application ID:** 10709598
- **Project number:** 5R44DK135139-02
- **Recipient organization:** INTRINSIC LIFESCIENCES, LLC
- **Principal Investigator:** Vaughn E Ostland
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2023
- **Award amount:** $788,664
- **Award type:** 5
- **Project period:** 2022-09-25 → 2026-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10709598

## Citation

> US National Institutes of Health, RePORTER application 10709598, Novel Point-of-Care Device for Urinary Hepcidin to Detect Iron Deficiency in Children and Adolescents (5R44DK135139-02). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10709598. Licensed CC0.

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