# A Rapid Breath Test for Invasive Aspergillosis

> **NIH NIH R44** · VOLATYLIX, INC. · 2020 · $1,000,000

## Abstract

Invasive aspergillosis (IA) is a leading cause of morbidity and death in immunocompromised patients, with over 30
million individuals at risk for IA and at least 200,000 IA cases developing worldwide each year. Despite the
development of potent triazole antifungal drugs for the treatment of IA, IA-associated mortality is still 22-40%.
Timely and accurate diagnosis of IA, in conjunction with prompt initiation of appropriate antifungal therapy,
improves patient outcomes, but is challenging due to the shortcomings of existing diagnostics. Due to the
limitations of IA diagnostics and the potentially severe clinical consequences of not treating IA promptly, clinicians
routinely prescribe empiric antifungal therapy to patients with suspected IA, exposing many patients who ultimately
do not have IA to unnecessary antifungal drugs, with their toxicities and costs. A major unmet need in the care of
immunocompromised patients is a diagnostic that can identify IA rapidly and accurately, without requiring invasive
procedures. To address this unmet need, we propose further development of a novel microfluidic gas
chromatography-differential mobility spectrometry (GC-DMS) breath analysis device for the rapid,
noninvasive diagnosis of IA, based on the scientific premise that patients with IA have a unique Aspergillus
volatile sesquiterpene secondary metabolite signature in their breath. We have demonstrated this premise in an
initial proof-of-concept study and subsequent validation study in patients with suspected invasive fungal disease.
Combining our expertise in engineering, diagnostic product development, and breath analysis, we have developed
an integrated, fully functioning GC-DMS Microanalyzer prototype for rapid bedside breath analysis,
successfully detecting these breath sesquiterpene metabolites in patients with IA using this device. The goal of
this Fast Track SBIR proposal is further optimization and development of the GC-DMS Microanalyzer breath
analysis platform for the rapid diagnosis of IA. The objective of phase I is to optimize the preconcentration of
sesquiterpene metabolites in the Microanalyzer device, lowering its limit of detection for these analytes and
evaluating its sensitivity in a set of patients with suspected invasive fungal disease. In phase II, aims are to: (1)
complete Microanalyzer diagnostic device development for IA under design control, incorporating general and
special control measures, (2) develop and validate GC-DMS peak-finding algorithms for the automated
identification of the IA breath signature, and (3) perform comprehensive analytical validation studies for this
GC-DMS Microanalyzer breath test for IA. Upon successful completion of these objectives, the Microanalyzer
breath test for IA will be ready for evaluation in a multicenter clinical validation study for FDA 510(k) clearance
and CE mark certification. This diagnostic device will transform the care of immunocompromised patients at
risk for IA, reducing diagnostic...

## Key facts

- **NIH application ID:** 9982769
- **Project number:** 5R44AI141264-03
- **Recipient organization:** VOLATYLIX, INC.
- **Principal Investigator:** Donald E Pogorzelski
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $1,000,000
- **Award type:** 5
- **Project period:** 2019-08-01 → 2022-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9982769

## Citation

> US National Institutes of Health, RePORTER application 9982769, A Rapid Breath Test for Invasive Aspergillosis (5R44AI141264-03). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/9982769. Licensed CC0.

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