Pearl Diagnostics, Inc.

Pearl Diagnostics is a Johns Hopkins University spin-off specializing in in vitro diagnostic assays for the detection of lung infections. The company's proprietary technology identifies circulating microbial extracellular vesicles (EVs) as biomarkers for early, non-invasive diagnosis of respiratory pathogens. Their lead product, MycoMEIA® Aspergillus Assay, received FDA 510(k) clearance in August 2025 and detects Aspergillus antigen in urine samples. The company is developing additional assays targeting common respiratory pathogens, including Pseudomonas aeruginosa, with support from the Cystic Fibrosis Foundation. Pearl Diagnostics serves infectious disease clinicians, pulmonologists, and hospital laboratories seeking non-invasive diagnostic tools for fungal and bacterial lung infections. The company provides technical support and educational resources to healthcare institutions.