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Pearl Diagnostics

Urine tests for invasive fungal lung infections

Raised to date

$11.2M

of $11.2M offered across 1 Form D filing

Investors
21
Last filed
Apr 21, 2026

About

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.

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.

Funding

  • EquityFiled Apr 21, 2026Form D
    $11.2M/ $11.2M

Product

MycoMEIA Aspergillus Assay

In-vitro diagnostic assay

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.

  • Urine specimen — no bronchoscopy or biopsy required
  • FDA 510(k) cleared and CE marked
  • 96-well microplate ELISA format on standard lab instrumentation

Built for

Hospital and reference clinical laboratories serving immunocompromised patient populations — transplant, hematology-oncology, and ICU services — in the US and Europe

People on file