CE Marking for MycAssay™ Product Family

Myconostica Ltd, who develop and commercialise rapid and highly specific tests for life-threatening fungal infections, have now have CE marking for their lead products MycAssay™ Aspergillus and MycAssay™ Pneumocystis on the Roche Lightcycler® 2.0 and Stratagene Mx3000 series platforms.

The CE marking on these two platforms in addition to the existing CE marking on the Cepheid Smartcycler® and Applied Biosystems ABI 7500 means these products are now available on the four real-time PCR machines most common in clinical microbiology and mycology laboratories.

• MycAssay™ Pneumocystis is a molecular diagnostic test for the detection of Pneumocystis jirovecii DNA in lower respiratory tract samples. The kit is designed to be used by qualified laboratory professionals; the results provided by MycAssay™ Pneumocystis aid physicians to make a diagnosis in patients suspected of having an infection caused by Pneumocystis jirovecii.


• MycAssay™ Aspergillus is a molecular diagnostic test for the detection of Aspergillus spp DNA in lower respiratory tract samples. The kit is designed to be used by qualified laboratory professionals; the results provided by MycAssay™ Aspergillus aid physicians to make a diagnosis in patients suspected of having an infection caused by Aspergillus.

When used in conjunction with Myconostica's fungal DNA extraction system, MycXtra® , a result can be obtained within 3 hours of sample receipt. The MycAssay™ products provide rapid and accurate results to physicians, enabling appropriate drug treatments to be administered thereby improving patient outcomes.

Dr. John Thornback, Myconostica's Chief Business Officer, said 'We are committed to developing diagnostics for life threatening diseases and we are dedicated to making our products available to the widest possible customer base. We recognise that our customers in the clinical laboratories have multiple opportunities for real-time PCR platforms and so we have an intensive ongoing programme to adapt our assays to fit in with our customers. These latest CE marks are part of that successful programme'.