# Development of a highly sensitive and specific POCT testing asthma triggering allergic IgE

> **NIH NIH R44** · ALLERDIA INC · 2024 · $1,109,675

## Abstract

Abstract
The overall goal of this project is to develop and eventually commercialize a novel Point-Of-Care Test capable
of rapidly and accurately detecting allergic IgE to environmental allergens in asthma patients as an approach
promoting healthy living and reducing minority health disparities in response to RFA-23-003. The burden of
asthma in the US falls disproportionately on Black, Hispanic and American Indian/Native Alaskans/Asians. These
minority groups have the highest asthma rates, deaths and hospitalizations. IgE-mediated allergic asthma is the
major type of asthma, consisting of ~70% of all the asthmas. The most relevant allergens triggering IgE-
mediated allergic asthmas are environmental allergens that disproportionately impact the socioeconomically
disadvantaged population and minorities due to their relatively constraint living conditions, lower available
resources and limited access to healthcare, leading to the existing health disparities. Therefore, a more
accurate, convenient, low-cost, rapid and point-of-care enabled IgE test capable of rapidly and accurately
identifying allergic IgE by overcoming false positivity of the current IgE tests would be a key component in efforts
to enhance healthy living and reduce minority health disparities, but such a point-of-care enabled IgE test is not
currently available and yet to be developed. Under such background we propose to develop a novel IgE testing
approach capable of rapidly and accurately detecting allergic IgE against the common allergens associated with
allergic asthma triggering to address the health disparity issue, using Allerdia’s proprietary Reverse Lateral Flow
ImmunoAssay (R-LFIA) technology platform. In Aim 1, we will Integrate the E. coIi expressed recombinant
allergens into R-LFIA based IgE test to achieve higher detecting sensitivity and consistent test accuracy. In Aim
2, we will validate clinical sensitivity and specificity of the prototypic R-LFIA IgE test as a novel allergy diagnostic
for rapid diagnosis of allergic asthmas in a prospective clinical study. Completion of the SBIR phase 2 Aims will
pave the way for the US FDA regulatory approval via FDA’s newly established De Novo approval pathway for
manufacture and commercialization of this novel IgE rapid test.

## Key facts

- **NIH application ID:** 10922887
- **Project number:** 2R44HL167289-02
- **Recipient organization:** ALLERDIA INC
- **Principal Investigator:** Asghar Abbasi
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $1,109,675
- **Award type:** 2
- **Project period:** 2023-02-01 → 2026-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10922887

## Citation

> US National Institutes of Health, RePORTER application 10922887, Development of a highly sensitive and specific POCT testing asthma triggering allergic IgE (2R44HL167289-02). Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/grant/nih/10922887. Licensed CC0.

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