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Pearl Diagnostics Announces Publication of Clinical Studies Supporting FDA Clearance of ...
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Fusion42 · 10 October 2026 · Fusion42 review
Pearl Diagnostics published clinical studies in Clinical Infectious Diseases supporting FDA 510(k) clearance of their MycoMEIA Aspergillus Assay, a non-invasive urine test for diagnosing invasive aspergillosis with 92% sensitivity. The assay offers a rapid, reliable alternative to invasive diagnostic methods and is CE-marked with validation in US and European centres.
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 should explore integrating PearlDX's urine-based test for invasive aspergillosis into your diagnostic portfolio to capture demand for less invasive fungal infection tools. This shifts the diagnosis market by reducing reliance on invasive procedures in lung infection care.
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3 sources · first reported 7 Oct 2026 · latest 8 Oct 2026
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