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Pearl Diagnostics Announces Publication of Clinical Studies Supporting FDA Clearance of ...
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Fusion42 · 11 October 2026 · Fusion42 review
Pearl Diagnostics published clinical studies confirming the FDA clearance of its urine-based MycoMEIA Aspergillus Assay, demonstrating 92% sensitivity for diagnosing invasive aspergillosis non-invasively. The assay offers a high-specificity alternative to traditional invasive testing methods and will be presented at IDWeek 2026.
This Wire brief sits within Fusion42's coverage of Medtech, and 3 sources have reported it between 7 Oct 2026 and 8 Oct 2026.
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You can now develop or integrate with urine-based Aspergillus diagnostics that gained FDA clearance, opening faster and less invasive testing paths. This clearance shifts the bar for fungal infection testing and creates room to replace blood-based assays.
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3 sources · first reported 7 Oct 2026 · latest 8 Oct 2026
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