Skip to main content
Pearl Diagnostics Announces FDA 510(k) Clearance for Groundbreaking MycoMEIA Aspergillus Urine AssayNewsPearl Diagnostics Announces FDA 510(k) Clearance for Groundbreaking MycoMEIA Aspergillus Urine Assay
August 6, 2025

Pearl Diagnostics Announces FDA 510(k) Clearance for Groundbreaking MycoMEIA Aspergillus Urine Assay

BALTIMORE--(BUSINESS WIRE) 6 August 2025 11:00 AM -- Pearl Diagnostics proudly announces that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the MycoMEIA® Aspergillus Assay –…
NewsCystic Fibrosis Foundation Invests in Pearl Diagnostics to Advance Non-Invasive Detection of Pseudomonas and Aspergillus in Cystic Fibrosis
June 17, 2025

Cystic Fibrosis Foundation Invests in Pearl Diagnostics to Advance Non-Invasive Detection of Pseudomonas and Aspergillus in Cystic Fibrosis

BALTIMORE  – June 17, 2025 – Pearl Diagnostics, a Johns Hopkins University spin-off specializing in non-invasive diagnostics for lung infections, announced today it has received a strategic investment from the…
NewsCarb-X funds Pearl Diagnostics to assess detection of bacterial pneumonia via urine sample.
February 11, 2025

Carb-X funds Pearl Diagnostics to assess detection of bacterial pneumonia via urine sample.

BOSTON -  February 11, 2025 – Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) will award biotechnology company Pearl Diagnostics US$1M to develop a low-cost, low turnaround time urine assay for the…
Pearl Diagnostics - Aspergillus sp. organismsNewsFatal Fungi Threaten Global Health, WHO Says
October 26, 2022

Fatal Fungi Threaten Global Health, WHO Says

Pearl Diagnostics develops tests to diagnose the critical fungal infections the WHO highlighted on Tuesday. As we work with partners including GAFFI-The Global Action Fund for Fungal Infections and scientific…
NewsPearl Diagnostics founder Dr. Kieren Marr’s journey to retirement — then to CEO
July 20, 2022

Pearl Diagnostics founder Dr. Kieren Marr’s journey to retirement — then to CEO

Dr. Kieren Marr retired from a faculty position at Johns Hopkins University at the beginning of this year because she knew the impact Pearl Diagnostics would have on diagnosing fungal…
Pearl DiagnosticsNewsRecent NewsBaltimore startup raises $3.5M as it prepares to seek FDA approval for new pneumonia test
July 18, 2022

Baltimore startup raises $3.5M as it prepares to seek FDA approval for new pneumonia test

A Baltimore medical company that aims to make it easier to diagnose a deadly type of pneumonia raised $3.5 million in an oversubscribed seed round. Pearl Diagnostics, led by Johns…
NewsPearl Diagnostics Publishes Paper in “Clinical Infectious Diseases”
April 18, 2018

Pearl Diagnostics Publishes Paper in “Clinical Infectious Diseases”

In April 2018, Pearl Diagnostics published a paper in Clinical Infectious Diseases titled: “Urine Antigen Detection as an Aid to Diagnose Invasive Aspergillosis”. Pearl Diagnostics in collaboration with Johns Hopkins University…

Join Our Mailing List for the latest product news







Contact Us
close slider