Pearl Diagnostics Announces FDA 510(k) Clearance for Groundbreaking MycoMEIA Aspergillus Urine Assay

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BALTIMORE--(BUSINESS WIRE)--Aug 6, 2025--

Pearl Diagnostics proudly announces that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the Myco MEIA ®Aspergillus Assay – the first urine-based assay to receive FDA clearance as an aid to diagnose Invasive Aspergillosis (IA), a common lung infection in immunocompromised people.

IA is a life-threatening complication in immunocompromised people, particularly in those receiving therapies for hematologic malignancies and transplants, and is increasingly recognized in people with severe acute and chronic lung disease. Traditional methods for diagnosing IA are complex and invasive, and suffer from low sensitivity, high costs, and delayed turnaround times. Diagnostic deficiencies force clinicians to use broad-spectrum antifungal therapies empirically, driving toxicities and drug-resistance. This has prompted global health organizations to call for urgent development of better diagnostic tools. For example, the WHO recently elevated Aspergillus to its fungal priority pathogens list, highlighting the critical demand for innovation in its diagnosis and prevention.

Pearl Diagnostics answers this call with the first non-invasive diagnostic, the Myco MEIAAspergillus Assay—a microplate-based enzyme-linked immunoassay (ELISA) that delivers a rapid and reliable aid to detect IA early in development. Clinical validation studies performed in U.S. and European centers demonstrate that the assay provides higher sensitivity and detects disease earlier than currently available options. Urine – based MycoMEIA testing thus has the potential to improve patient outcomes and reduce unnecessary use of antifungal medications.

Dr. Johan Maertens, Professor and Physician of Hematology at University Hospital Leuven, emphasized, “The high negative predictive value of this assay should empower clinicians to withhold unnecessary antifungal therapies in severely ill patients. 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.”

Dr. Kieren Marr, inventor and founder of Pearl Diagnostics, emphasized the significance of this FDA clearance, stating, “The milestone marks the culmination of decades of translational efforts and we are indebted to the individuals who provided urine samples to assist development. Hopefully we can take this forward towards improving patient outcomes.”

About Pearl Diagnostics

Pearl Diagnostics Inc. (PearlDx) is a Johns Hopkins spin-off company that develops novel in-vitro diagnostic tests for non-invasive detection of life-threatening lung infections. Its proprietary Smart Antibody™ technology detects microbial extracellular vesicles in urine, enabling early diagnosis of bacterial and fungal infections. PearlDx’s Myco MEIA - Aspergillus assay is FDA cleared and CE marked.

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For additional information, media inquiries, or partnership opportunities, please contact Pearl Diagnostics [email protected].

KEYWORD: UNITED STATES NORTH AMERICA MARYLAND

INDUSTRY KEYWORD: RESEARCH MEDICAL DEVICES INFECTIOUS DISEASES FDA GENERAL HEALTH PHARMACEUTICAL HEALTH SCIENCE ONCOLOGY OTHER SCIENCE

SOURCE: Pearl Diagnostics

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PUB: 08/06/2025 11:00 AM/DISC: 08/06/2025 11:00 AM

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