$11.2M
+$11.2M this year1 filing since 2026 · latest Equity filed
Pearl Diagnostics is a Baltimore-based in-vitro diagnostics company developing non-invasive urine tests for life-threatening lung infections. Its Smart Antibody technology detects microbial antigens and extracellular vesicles shed into urine, letting clinicians screen for invasive fungal and bacterial infection without a bronchoscopy or biopsy. Its lead product, the MycoMEIA Aspergillus Assay, received FDA 510(k) clearance in 2025 as the first urine-based assay cleared to aid diagnosis of invasive aspergillosis, having carried a European CE mark since 2022. The company spun out of Johns Hopkins University in 2014 as MycoMed Technologies and rebranded to Pearl Diagnostics in 2022; it is developing further tests on the same platform, including one for Pseudomonas infection.
What sets it apart
The first and only FDA-cleared urine assay for invasive aspergillosis — replacing invasive bronchoscopy sampling with a urine specimen, and running as a standard 96-well ELISA on equipment clinical labs already own rather than requiring a proprietary instrument.
A non-invasive urine ELISA that detects Aspergillus fumigatus galactofuranose antigen using proprietary monoclonal Smart Antibodies, used as an aid in diagnosing invasive aspergillosis in at-risk patients.
