# First-in-class, highly sensitive and specific rapid diagnostic test to detect Paragonimus infections

> **NIH NIH R43** · BIG EYE DIAGNOSTICS, INC. · 2022 · $258,171

## Abstract

PROJECT SUMMARY / ABSTRACT
Herein, we propose an ultrasensitive serological rapid diagnostic test (RDT) to detect exposure to pulmonary flukes of the
genus Paragonimus. Paragonimiasis affects an estimated 21 million people and remains amongst the most neglected of
all neglected tropical diseases (NTDs). Trematodes of the genus Paragonimus are acquired upon ingestion of raw or
undercooked freshwater crustaceans and migrate to the lungs where they encyst. Treatment is straightforward
(praziquantel) but diagnosis is not. The classical method – detection of Paragonimus eggs in sputum or stool – requires
rarely available microscopy expertise, is slow and hence low-throughput.
With an effective drug at hand but no convenient diagnostic, a highly sensitive and specific RDT is the missing piece to
enable efficient clinical management of paragonimiasis. RDTs represent a mature, robust, and cost-effective technology
ideal for intervention at the point of care in resource-limited countries. An additional important problem is that many
paragonimiasis symptoms resemble those of TB or lung cancer, including hemoptysis (blood in sputum), persistent cough,
weight loss, and cysts in CT scans. As a result, misdiagnosis is common and patients are incorrectly put on long and
ineffective antibiotic regimens or on toxic cancer chemotherapy, with abysmal consequences for the patients. The
importance of differential diagnosis between paragonimiasis and other pulmonary diseases further underscores the need
for a Paragonimus RDT.
The project will leverage novel paragonimiasis biomarkers, notably a cysteine protease (CP-6) and myoglobin-1, recently
discovered at the Washington University School of Medicine after an extensive effort of genome sequencing. In previous
work, we developed an RDT prototype that detects IgG4 antibodies against CP-6 with 89% sensitivity and 100% specificity
when evaluated on a small panel of positive (n=19) and negative (n=28) sera. The RDT utilizes a novel lateral-flow assay
(LFA) set-up combined with novel plasmonic reporter nanoparticles (gold nanoshells) for superior optical detection.
However, some test lines were weak, and further optimization is required to warrant manufacturing. Even more
importantly, assay development was severely limited by the paucity of clinical samples. Therefore, a particular focus of
this proposal is to assemble a collection of paragonimiasis sera, in collaboration with Dr. Belizario, Dean and Professor,
College of Public Health, University of the Philippines, Manila.
We are therefore requesting funding to assemble such a biorepository of both paragonimiasis-positive and -negative
patient samples (Specific Aim 1), to further optimize the sensitivity of the prototype RDT without impairing the specificity,
e.g., by generating a biplex assay to simultaneously detect IgG4 antibodies against both antigens, CP-6 (test line 1) and
myoglobin-1 (test line 2), whereby the appearance of either test line would be counted as pos...

## Key facts

- **NIH application ID:** 10545410
- **Project number:** 1R43AI172459-01
- **Recipient organization:** BIG EYE DIAGNOSTICS, INC.
- **Principal Investigator:** Marco Antonio Biamonte
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $258,171
- **Award type:** 1
- **Project period:** 2022-09-14 → 2024-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10545410

## Citation

> US National Institutes of Health, RePORTER application 10545410, First-in-class, highly sensitive and specific rapid diagnostic test to detect Paragonimus infections (1R43AI172459-01). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10545410. Licensed CC0.

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