Myconostica, a UK based medical diagnostic company specialized in rapid molecular diagnostic tests for life-threatening fungal infections, has released the multicentre prospective trial results of its CE marked kit - MycAssay Pneumocystis, for the detection of Pneumocystis jirovecii.
The trial results compare well with clinical diagnosis using non-molecular methods and demonstrate the high sensitivity and specificity of the PCR diagnostic assay.
The trial recruited 110 subjects from a variety of underlying diseases and conditions including solid organ transplants, leukaemia, solid tumors and HIV.
Respiratory bronchoalveolar samples were analyzed and 13/14 patients with clinically proven Pneumocystis pneumonia (PCP) were identified and 9/96 patients without PCP at the time of the test also gave positive results.
Subsequently one of these patients developed PCP while the others were considered to be colonized with Pneumocystis jirovecii.
Myconostica chief business officer John Thornback said the introduction of new technologies such as Pneumocystis PCR often results in reappraisal of disease and this may be the case here.
"Myconostica is committed to working with the clinical community to better understand the role that PCR can play in the diagnosis of life threatening fungal infections, such as Pneumocystis, as early as possible in at risk patient populations," Thornback said.