Born from a Johns Hopkins University spinout founded in 2014, Pearl Diagnostics develops in vitro diagnostic assays that help clinicians detect lung infections through microbial extracellular vesicles. The Baltimore company’s MycoMEIA Aspergillus Assay is its signature achievement: a non-invasive urine test that delivers results in about three hours and received FDA 510(k) clearance in 2025. Pearl Diagnostics is woman-owned and operates under an ISO 13485 quality system.
FDA 510(k) clearance for MycoMEIA Aspergillus Assay
certification
CE Mark for MycoMEIA Aspergillus Assay
certification
ISO 13485
certification
Financial Conflict of Interest Policy under 42 CFR Part 50 Subpart F
compliance_program
U.S. Small Business Administration Women-Owned Small Business (WOSB)
registration