Pearl Diagnostics (PearlDX), a company pioneering a new generation of non-invasive tests for lung infections, today announced the publication of clinical studies supporting U.S. Food and Drug Administration (FDA) 510(k) clearance of the MycoMEIA® Aspergillus Assay in the peer-reviewed journal Clinical Infectious Diseases. The studies evaluated the urine-based assay as an aid to diagnose invasive aspergillosis (IA), a potentially life-threatening fungal infection in people with weakened immune systems.
The publication, “Performance of the Urinary MycoMEIA Aspergillus Assay as an Aid to Diagnose Invasive Aspergillosis,” reports a case-control study involving 50 patients with proven or probable IA and 240 controls. MycoMEIA produced at least one positive result in 46 of the 50 patients with IA, corresponding to 92% sensitivity. Specificity was 87.6% across 249 control urine samples. The full article is available here.
Among 24 patients whose infection was established through lung sampling or biopsy but whose serum galactomannan tests were negative, 19 had at least one positive MycoMEIA result. The publication also reports a prospective study in which fresh urine samples were tested within six hours of collection in a Johns Hopkins hospital laboratory, with specificity comparable to that observed using previously frozen samples. Results were also highly reproducible across three laboratories.
“Publication of these studies gives clinicians a fuller view of the evidence supporting MycoMEIA and its role as a non-invasive aid to diagnose invasive aspergillosis,” said Eric Gornstein, Chief Executive Officer of PearlDX. “It is an important step toward our broader goal of making serious lung infections easier to identify through non-invasive testing. We are building on decades of research to turn discoveries about microbial extracellular vesicles into practical tools for clinicians.”
MycoMEIA Aspergillus Assay is the first urine-based test to receive FDA clearance as an aid to diagnose IA, providing rapid, reliable diagnostic information through non-invasive testing. The assay uses a microplate-based enzyme-linked immunoassay (ELISA), offering an alternative to diagnostic approaches that require invasive specimens. Clinical validation studies in U.S. and European centers support its potential to detect infection earlier and help clinicians make more informed decisions about antifungal treatment. The assay is also CE-marked.
The latest publication builds on research published in August 2026 in the Journal of Infectious Diseases, which described the biological basis of the MycoMEIA Aspergillus assay. The study showed that the assay detects fungal antigens associated with Aspergillus extracellular vesicles in urine and that combining two antibodies improved detection across patient samples.
“Invasive aspergillosis can be difficult to confirm, and our current commercial blood-based assay doesn’t have high enough sensitivity to rule out infection,” said Kieren Marr, M.D., MBA founder of PearlDX and a co-author of the publication. “The high sensitivity of urine testing adds to our current diagnostic options, enabling more clinical certainty with non-invasive testing.”
PearlDX will also present clinical data on MycoMEIA at IDWeek 2026. Presentation details are as follows:
Poster Title: “Performance of Urine MycoMEIA – Aspergillus with Serum Galactomannan Testing as an Aid to Diagnose Invasive Aspergillosis”
Number: P-678
Date & Time: Thursday, October 22, 2026, 12:15 – 1:30p.m. ET
Location: Walter E. Washington Convention Center, Poster Hall B-C
About Pearl Diagnostics
Pearl Diagnostics (PearlDX) is developing a new generation of non-invasive tests to help clinicians identify serious lung infections. Founded on technology developed at Johns Hopkins University, PearlDX builds on decades of research in infectious diseases and diagnostic development. Its platform uses proprietary Smart Antibody™ technology to recognize microbial extracellular vesicles, microscopic particles released by pathogens that can be detected in urine. PearlDX is applying this approach to develop diagnostics for fungal and bacterial infections. For more information, visit pearldx.com or follow us on LinkedIn.
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