The company that turned a cup of urine into the first FDA-cleared test for a deadly fungal lung infection - no biopsy required.
Invasive aspergillosis is the kind of infection that hides. It takes hold in the lungs of people whose immune systems are already stretched thin - cancer patients on chemotherapy, transplant recipients, those with severe lung disease - and by the time older tests catch it, the window for treatment has often narrowed. The traditional route to a diagnosis runs through biopsies, bronchoscopies, blood draws, and days of waiting.
Pearl Diagnostics, an in vitro diagnostics company based in Baltimore, built a different door in. Its lead product, the MycoMEIA Aspergillus Assay, reads a urine sample and looks for the molecular fingerprints that the fungus leaves behind - specifically, circulating microbial extracellular vesicles. On August 6, 2025, it became the first urine-based assay to earn FDA 510(k) clearance as an aid in diagnosing invasive aspergillosis. In clinical validation across US and European centers, it reported roughly 90% sensitivity with a high negative predictive value, and detected disease earlier than existing options.
The company describes itself simply: it is dedicated to transforming diagnostics for lung infections by developing non-invasive in vitro tests that detect circulating microbial extracellular vesicles. In plainer terms - it wants clinicians to know sooner, and patients to endure less to find out.
"The milestone marks the culmination of decades of translational efforts, and we are indebted to the individuals who provided urine samples to assist development."
Dr. Kieren Marr — Founder, Pearl DiagnosticsFor an immunocompromised patient, an invasive fungal infection is a race against time. The World Health Organization recently placed Aspergillus fumigatus on its list of fungal priority pathogens, a signal that the clinical stakes - and the diagnostic gaps - are widely recognized. Yet the tools most labs reach for can be invasive, costly, and slow, and they can miss disease early on.
Pearl's answer trades the scope for a sample cup. A urine test can be repeated easily and non-invasively, which matters when clinicians want to monitor an at-risk patient over time rather than gamble on a single snapshot. That is the practical promise: earlier signal, less burden, faster decisions.
Figures reflect company-reported clinical validation and product format; comparison is directional, not a head-to-head trial.
A microplate-based ELISA that detects Aspergillus signal in urine - the first of its kind to clear the FDA.
The assay is designed to fit the way hospital and clinical microbiology labs already work: a familiar ELISA workflow, high-volume plates, and reagents ready off the shelf. Underneath it sits Pearl's proprietary Smart Antibody technology, which targets the extracellular vesicles microbes shed - tiny biological packages that carry the evidence of infection into the urine.
That same platform is the foundation for a broader ambition: extending non-invasive detection from fungal to bacterial lung infections, reading the microbial "communication" that infections leave in their wake.
Hospital and clinical microbiology laboratories, infectious-disease physicians, and oncology and transplant centers caring for immunocompromised patients most at risk of invasive aspergillosis.
An IVD manufacturer selling microplate immunoassay kits to labs. Revenue comes from assay/kit sales, backed by ISO 13485 quality certification and a woman-owned small business (WOSB) footprint.
Alongside established galactomannan, beta-D-glucan, PCR, and culture-based tests from players like Bio-Rad, IMMY, and Associates of Cape Cod - Pearl carves out the urine-based, non-invasive niche.
Where competitors typically test serum, blood, or bronchoalveolar lavage fluid, Pearl's differentiator is the sample itself. A urine-based, repeatable test changes the ergonomics of monitoring a fragile patient, and being first through the FDA for that approach gives the company a defensible position in a category it effectively opened.
The commercial strategy is straightforward. The March 2026 Series A - $11.2 million - is earmarked to launch US sales of the cleared assay and to push further into Europe, where the product already carries a CE mark. It is the move from proven science to routine clinical shelf.
Pearl Diagnostics began in 2014 as MycoMed Technologies, a Johns Hopkins University spinout co-founded by Dr. Kieren Marr and MaryAnn Shallcross. Marr - a professor at Johns Hopkins and, by the company's account, among the world's most-cited researchers on fungal infections in immunosuppressed hosts - has spent more than 25 years on the problem the company now sells against. She serves as founder and president and chairs the board. Eric Gornstein, who brings decades of biopharma commercialization experience, leads the company as CEO.
The rest of the team is small and technical - a research and development group led by VP Irina Baburina, PhD, with roughly 25 years in the IVD industry, supported by scientists with long tenures in infectious-disease research. It is a compact operation that reached a first-in-class FDA clearance with a team of around five, an unusual feat in medical devices.
Kieren Marr and MaryAnn Shallcross launch a Johns Hopkins spinout to commercialize fungal-infection diagnostics.
The company adopts the Pearl name and builds out its Smart Antibody, extracellular-vesicle platform.
The MycoMEIA Aspergillus Assay earns CE marking, opening European commercialization.
MycoMEIA becomes the first urine-based assay cleared to aid diagnosis of invasive aspergillosis (Aug 6, 2025).
Pearl closes a Series A in March to launch US sales and expand across Europe.
Non-invasive in vitro diagnostic tests for lung infections. Its lead product, the MycoMEIA Aspergillus Assay, is a urine-based ELISA that aids in diagnosing invasive aspergillosis.
Yes. It received FDA 510(k) clearance on August 6, 2025, making it the first urine-based assay cleared to aid diagnosis of invasive aspergillosis. It is also CE-marked in Europe.
Pearl's proprietary Smart Antibody technology detects circulating microbial extracellular vesicles in urine, providing an early, non-invasive signal of infection instead of relying on biopsy or invasive sampling.
Primarily immunocompromised people - cancer and hematologic-malignancy patients, transplant recipients, and those with severe lung disease - who are at high risk of invasive aspergillosis.
Founded in 2014 (as MycoMed Technologies) by Dr. Kieren Marr and MaryAnn Shallcross out of Johns Hopkins. Eric Gornstein serves as CEO, with Dr. Marr as founder and president.
Profile compiled from public sources including pearldx.com, FDA/company press releases, BioSpace, BusinessWire and Technical.ly. Figures such as clinical sensitivity are company-reported and approximate.