# Pearl Diagnostics, Inc.

> Pearl Diagnostics is a Baltimore-based in vitro diagnostics company spun out of Johns Hopkins University that develops non-invasive urine tests to detect life-threatening lung infections. Its proprietary Smart Antibody technology identifies circulating microbial extracellular vesicles, and its lead product, the MycoMEIA Aspergillus Assay, became the first urine-based test to win FDA 510(k) clearance for aiding diagnosis of invasive aspergillosis. The company raised an $11.2M Series A in March 2026 to commercialize in the US and expand across Europe.

- **Founded:** 2014
- **Headquarters:** Baltimore, Maryland, United States
- **Founders:** Kieren Marr (Founder, President & VP of Clinical Development; Board Chair), MaryAnn Shallcross (Co-founder (MycoMed Technologies))
- **Team size:** ~5 employees
- **Products:** MycoMEIA Aspergillus Assay (Urine), Smart Antibody Technology Platform
- **Notable:** First urine-based assay to receive FDA 510(k) clearance for aiding diagnosis of invasive aspergillosis (August 6, 2025)., CE Mark for the MycoMEIA Aspergillus Assay in Europe., Clinical validation showing ~90% sensitivity with high negative predictive value across US and European centers.

## Products & services

- **MycoMEIA Aspergillus Assay (Urine)** — A microplate-based ELISA (96-test format) and the first urine-based diagnostic to receive FDA 510(k) clearance as an aid in diagnosing invasive aspergillosis. Uses proprietary Smart Antibody technology to detect microbial extracellular vesicles, achieving roughly 90% sensitivity with high negative predictive value. CE-marked in Europe.
- **Smart Antibody Technology Platform** — Proprietary antibody technology that detects circulating microbial extracellular vesicles in urine, enabling non-invasive detection of bacterial and fungal lung infections; foundation for a broader pipeline of infection diagnostics.

## Achievements

- First urine-based assay to receive FDA 510(k) clearance for aiding diagnosis of invasive aspergillosis (August 6, 2025).
- CE Mark for the MycoMEIA Aspergillus Assay in Europe.
- Clinical validation showing ~90% sensitivity with high negative predictive value across US and European centers.
- Closed $11.2M Series A in March 2026 to fund US commercialization and European expansion.
- ISO 13485 and WOSB certifications.

## Latest updates

- **2026-03** — Closed an $11.2M Series A to launch US sales of the MycoMEIA Aspergillus Assay and expand into Europe.
- **2025-08** — Received FDA 510(k) clearance for the MycoMEIA Aspergillus Assay - the first urine-based test cleared to aid diagnosis of invasive aspergillosis.

## Links

- Website: https://pearldx.com
- LinkedIn: http://www.linkedin.com/company/pearl-diagnostics

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Profile page: https://yespress.io/pearl-diagnostics-inc
Published by YesPress — https://yespress.io
Last updated: 2026-07-18