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for Lung Infections

Pearl Diagnostics is changing the way clinicians diagnose lung infections. Our in vitro diagnostics identify circulating microbial extracellular vesicles.

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CID publicationNewsRecent NewsPearl Diagnostics Announces Publication of Clinical Studies Supporting FDA Clearance of MycoMEIA® Aspergillus Assay
October 7, 2026

Pearl Diagnostics Announces Publication of Clinical Studies Supporting FDA Clearance of MycoMEIA® Aspergillus Assay

- Clinical studies demonstrate MycoMEIA’s performance as a non-invasive aid to diagnose invasive aspergillosis, with 92% sensitivity in a case-control study – - PearlDX to present clinical data on MycoMEIA…
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 –…

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