Myconostica Ltd presented positive data from a multi-centre prospective evaluation of MycAssay™ Pneumocystis, the Company’s CE marked diagnostic product for detection of Pneumocystis DNA in respiratory samples.
A Multinational Prospective Evaluation of a Commercial Pneumocystis Real-Time PCR test (Paper M-417a). The clinical data were presented at the 50th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Boston on September 12th. The study was carried out in four hospitals located in Austria, Switzerland and the USA.
Data from the evaluation were presented for the study group by lead investigator, Jacques Bille, MD, CHUV Lausanne, Switzerland. A key outcome from the study showed that the sensitivity and specificity of the test were 93% and 91% respectively, when compared with final clinical diagnosis.
131 unique subjects were evaluated of which 110 gave analysable data. The underlying clinical conditions that contributed to the at-risk patient status were transplants (50), non malignant conditions (32), leukemia (13), solid tumours (11) and HIV+ (9). Fourteen subjects were clinically diagnosed with PCP and 13 of these were positive using the MycAssay™ Pneumocystis. For the 14th subject, the clinical sample was low volume and poor quality, as noted by the site. 9 patients without pneumocystis pneumonia (PCP) had positive MycAssay™ Pneumocystis results. Of these, on clinical follow up, one subsequently developed PCP. These results suggest that the increased sensitivity of the molecular assay may be indicative of asymptomatic latent disease in the at-risk patient group.
MycAssay™ Pneumocystis, is a novel molecular diagnostic test, specific to Pneumocystis jirovecii. The test is CE marked and Health Canada approved for diagnostic purposes on the most commonly available real-time PCR thermocyclers on the market.
Pneumocystis jirovecii is a fungal pathogen that causes pneumocystis pneumonia, a common and serious opportunistic infection in immunocompromised patients. If undiagnosed and/or untreated it can lead to respiratory failure and death. Unlike most pathogens P. jirovecii cannot be cultured and current diagnosis relies upon radiologic evidence and microscopic methods including immunofluorescence. MycAssay™ Pneumocystis is the first commercially available molecular assay to be evaluated in a multi-centre multinational prospective study looking at the at risk population for this serious and potentially fatal disease.
Dr. John Thornback, Myconostica’s Chief Business Officer, said: “MycAssay™ Pneumocystis is a robust, standardardised and easy to use assay, that delivers a result within four hours. The study shows a high sensitivity and specificity for detection of the pathogen with a very high negative predictive value suggesting a possible role for the assay in ruling out the presence of this pathogen.”