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