Ploughshare spin-out company, Enigma Diagnostics Ltd, announces that it has successfully completed analytical and diagnostic verification of its FluAB-RSV diagnostic assay on the Enigma® ML system at Guy’s and St Thomas’ NHS Foundation Trust, and will conclude clinical validation and CE marking of the test in 2013.
The Enigma ML system has the capability to deliver PCR-based results from a raw sample in about 60 minutes and Enigma, in addition to the FluAB-RSV test, is developing a series of deeply multiplexed assays for the ML including panel tests for respiratory viruses, MDR-TB and other respiratory infections.
John McKinley, Chairman of Enigma Diagnostics, said:
“We are delighted to be collaborating with such a prestigious and influential clinical centre. Having achieved such an exceptional diagnostic performance on our ML system with the FluAB-RSV assay, we are now ready for validation and CE marking.”
Dr Jonathan Edgeworth, Consultant Microbiologist and Head of the Centre for Clinical Infection and Diagnostics Research, said:
“We are pleased that Enigma has chosen Guy’s and St. Thomas’ as its partner to test the performance of the ML system. This will provide an opportunity to influence the development of a testing system that has the potential to benefit patients in the future.”