# MycoMEIA - Urine Diagnostic for Aspergillosis

> **NIH NIH R44** · PEARL DIAGNOSTICS, INC. · 2021 · $976,576

## Abstract

Aspergillosis causes morbidity and death in medically immune compromised patients,
especially after cancer chemotherapy and transplant. Recently, we have witnessed
increased cases of influenza-associated aspergillosis and COVID-19-associated
aspergillosis, complicating effective treatment in those critically ill with viral infections.
Outcomes are poor in part because we lack sensitive diagnostic tests that are easy to
use during high-risk periods. During our efforts to develop easier diagnostic tests, we
discovered that fungal galactofuranose (galf)– containing antigens are excreted in urine
of infected animals and people, using novel monoclonal antibodies. We engineered a
prototype enzyme immunoassay called MycoMEIA, and performance was tested using
urine samples obtained from patients with suspected and confirmed IA. Results showed
>80% sensitivity and specificity, meeting predefined metrics for clinical study. As part of
this proposal, this design-locked assay will move into clinical study, in three clinical
microbiology laboratories to support FDA 510k application. Additional work is proposed to
understand how the urine assay can be optimized to detect aspergillosis in non-hematology
patients at risk, including ICU patients with COVID-19. Success in meeting the milestones
described will lead to commercial availability of the first rapid, easy to use urine diagnostic
assay for this important fungal infection, with potential to reduce disease prevalence and
improve outcomes.

## Key facts

- **NIH application ID:** 10155041
- **Project number:** 1R44AI157572-01
- **Recipient organization:** PEARL DIAGNOSTICS, INC.
- **Principal Investigator:** Michael Hannan
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $976,576
- **Award type:** 1
- **Project period:** 2021-03-08 → 2023-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10155041

## Citation

> US National Institutes of Health, RePORTER application 10155041, MycoMEIA - Urine Diagnostic for Aspergillosis (1R44AI157572-01). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10155041. Licensed CC0.

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