Pearl Diagnostics put the clinical data behind its MycoMEIA Aspergillus Assay into Clinical Infectious Diseases this month. The urine ELISA from the Baltimore company is 510(k) cleared as an aid to diagnosing invasive aspergillosis and is also CE marked. Pearl is a 2014 Johns Hopkins spinout that operated as MycoMed Technologies until 2022.
The case-control study compared 50 patients with proven or probable invasive aspergillosis against 240 controls. At least one positive result came back in 46 of the 50 cases, a sensitivity of 92 percent, with specificity of 87.6 percent. Among 24 patients whose infection was confirmed by lung sampling or biopsy but whose serum galactomannan was negative, 19 had at least one positive MycoMEIA result.
A separate study at a Johns Hopkins laboratory found specificity with fresh urine tested within six hours comparable to frozen samples, and results reproduced across three laboratories. An earlier paper in the Journal of Infectious Diseases, published in August, set out the biological basis and reported that combining two antibodies improved detection. The company presents poster P-678 at IDWeek on October 22.
The galactomannan-negative subgroup is the number that sells this test, since those are the patients a clinician cannot currently call from a blood draw. The fresh-versus-frozen comparison and the three-laboratory reproducibility work are the other half, because lab directors ask for both before they validate an assay.