Trial results for MycAssay Pneumocystis kit published

11 April 2011

UK medical diagnostics company Myconostica, has announced the publication of a multicentre prospective trial of its CE marked kit, MycAssay Pneumocystis. The kit is used to detect the life-threatening fungal infection 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 tumours and HIV. Respiratory bronchoalveolar samples were analysed 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 colonised with Pneumocystis jirovecii.

PCP remains a formidable infection in both AIDS and non-AIDS patients with mortality rates in excess of 20%. Establishing the diagnosis of PCP is currently performed by microscopy of lung tissue, bronchial lavage or other deep respiratory samples. PCP primarily affects the alveoli; consquently deep pulmonary samples are necessary for adequate microscopy. Many fewer organisms are usually present in non-AIDS patients with PCP, which adversely affects diagnostic performance of the microscopic tests.

Dr John Thornback, Chief Business Officer of Myconostica said: "This is, to our knowledge, the first multi centre prospective trial of a commercial PCR test for Pneumocystis. Pneumocystis PCR is clearly a very sensitive means of detecting this fungal pathogen in at risk patients. The introduction of new technologies such as Pneumocystis PCR often results in reappraisal of disease, and this may be the case here.

"The early identification of infected patients may open opportunities for early interventions. 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."