Rapid Urine Assay Shows Clinical Performance for Invasive Aspergillosis
Published in Diseases!, Journals, Noninvasive, Tools.
Publication date: October 10, 2026.
A study published October 7 in Clinical Infectious Diseases reports clinical performance of MycoMEIA, a urine assay designed to help diagnose invasive aspergillosis. The fungal infection can be especially dangerous in people with severely weakened immune systems.
The assay detects Aspergillus glycans and generates results in approximately 3.5 hours. In a case-control analysis involving 50 infection cases and 240 controls, reported sensitivity was 92% and specificity 87.6%. Prospective testing found specificity of 89.7%; cross-reactivity with some other fungi was observed.
Johns Hopkins Medicine says the test received FDA clearance in late 2025 for adults with suspected invasive aspergillosis. The October publication provides supporting clinical data; it is not a new clearance announcement.
The test is intended to complement clinical assessment, imaging and other laboratory tests. Its performance does not establish improved survival or justify use as a stand-alone diagnosis. Further research is needed to define screening applications and performance in broader populations.
Pearl Diagnostics and the NIH funded the study; several authors disclosed company employment or shareholdings.
Primary sources: Clinical Infectious Diseases, October 7, 2026; Johns Hopkins Medicine announcement, October 7, 2026.