BALTIMORE — October 7, 2026

Pearl Diagnostics (PearlDX) announced the publication of clinical studies supporting the U.S. Food and Drug Administration (FDA) 510(k) clearance of its MycoMEIA® Aspergillus Assay in the peer-reviewed journal Clinical Infectious Diseases. The urine-based diagnostic test is designed to aid in diagnosing invasive aspergillosis (IA), a potentially life-threatening fungal infection that primarily affects people with weakened immune systems. The published findings provide clinical evidence for a non-invasive testing approach that could complement existing diagnostic methods.

Case-Control Study Reports 92% Sensitivity

The published case-control study evaluated 50 patients with proven or probable invasive aspergillosis and 240 controls. MycoMEIA produced at least one positive result in 46 of the 50 patients, corresponding to 92% sensitivity, while specificity was 87.6% across 249 control urine samples. Among 24 patients whose infections were confirmed through lung sampling or biopsy despite negative serum galactomannan tests, 19 had at least one positive MycoMEIA result. These findings suggest the assay may provide additional diagnostic information for some patients whose infections are not detected by conventional blood-based testing.

Prospective Testing Supports Reproducibility

The publication also included a prospective evaluation in which fresh urine samples were tested within six hours of collection at a Johns Hopkins hospital laboratory. Specificity was comparable to that observed with previously frozen samples, and results were highly reproducible across three laboratories. MycoMEIA uses a microplate-based enzyme-linked immunosorbent assay (ELISA) to detect fungal antigens associated with Aspergillus extracellular vesicles in urine. The approach is intended to provide diagnostic information without requiring invasive specimen collection, potentially complementing other tests used to assess suspected fungal infections.

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PearlDX Advances Non-Invasive Infectious Disease Diagnostics

The latest publication builds on earlier research describing the biological basis of the MycoMEIA assay, including the use of antibodies to improve detection of Aspergillus-associated antigens. PearlDX plans to present additional clinical data at IDWeek 2026 on October 22, with a poster titled “Performance of Urine MycoMEIA – Aspergillus with Serum Galactomannan Testing as an Aid to Diagnose Invasive Aspergillosis.” The company is developing non-invasive diagnostic tests based on its proprietary Smart Antibody™ technology, which targets microbial extracellular vesicles detectable in urine. The platform is being applied to fungal and bacterial infections, with the aim of supporting earlier identification and more informed clinical decision-making.

Source::Pearl Diagnostics, press release