Urine-Based Assay Diagnoses Common Lung Infection in Immunocompromised People

Invasive Aspergillosis (IA), a life-threatening fungal infection, poses a serious threat to immunocompromised individuals, especially those with hematologic malignancies, transplants, or severe lung diseases. Traditional IA diagnostic methods are invasive, costly, and slow, with limited sensitivity—often forcing clinicians to rely on broad-spectrum antifungal treatments. Global health agencies, including the WHO, have called for better diagnostic tools as drug resistance and toxicity rise. Now, a groundbreaking urine assay offers a non-invasive diagnostic approach for detecting IA

Pearl Diagnostics’ (Baltimore, MD, USA) MycoMEIA Aspergillus Assay is intended for aiding the diagnosis of IA. The test uses a microplate-based enzyme-linked immunoassay (ELISA) to detect biomarkers of the infection through a non-invasive urine sample. The assay leverages proprietary Smart Antibody technology to identify microbial extracellular vesicles.

Image: MycoMEIA Aspergillus Assay is the first FDA-cleared urine-based test for invasive aspergillosis (Photo courtesy of Pearl Diagnostics)

The MycoMEIA assay underwent clinical validation at U.S. and European centers. Results showed that it offers higher sensitivity than current tests and can detect the disease earlier in its progression. With a sensitivity of approximately 90%, the tool also provides a strong negative predictive value—enabling clinicians to rule out IA confidently and avoid unnecessary treatments.

The MycoMEIA assay could lead to major improvements in care for at-risk patients, offering earlier intervention and reducing the toxic side effects from unnecessary antifungal use. The assay’s ability to reduce unnecessary medication use could also improve antifungal stewardship. The FDA has granted 510(k) clearance to the MycoMEIA assay, making it the first urine-based assay to receive FDA clearance as an aid to diagnose IA. The assay also carries a CE mark, indicating its potential for use in global clinical settings.

"The high negative predictive value of this assay should empower clinicians to withhold unnecessary antifungal therapies in severely ill patients," said Dr. Johan Maertens, Professor and Physician of Hematology, University Hospital Leuven. “Meanwhile, its sensitivity approximating 90% provides an excellent, non-invasive, and timely tool to diagnose invasive aspergillosis, the most common mold infection, in at-risk patients suspected of having this fungal disease.”

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