Enigma Diagnostics Announces Successful Completion of Flagship Enigma® ML System Evaluation at Guy's and St. Thomas' NHS Foundation Trust, London, UK

SALISBURY, England, July 29, 2013 /PRNewswire/ --

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.

Enigma has installed a number of mini laboratory (ML) instruments at Guy's and St. Thomas' for use at the Trust's Centre for Clinical Infection and Diagnostics Research (CIDR). During May and June 2013, several hundred clinical samples, obtained by Enigma from patients in Africa with symptoms of respiratory disease, were processed on the Enigma^® ML system and compared with data from the Luminex xTAG respiratory viral panel, showing comparable sensitivity and specificity between the two systems.  The Enigma^® ML achieved negative predictive value (NPV) and positive predictive value (PPV) values of 100% for the FluB and respiratory syncytial virus (RSV) components of the assay and NPV and PPV of 97% and 100% for the FluA component of the assay.

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 Enigma^® ML including panel tests for respiratory viruses, multi-drug resistant tuberculosis 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 Enigma^® 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 Enigma^® ML system. This will provide an opportunity to influence the development of a testing system that has potential to benefit patients in the future.

Enigma Diagnostics is attending the AACC Annual Meeting and Clinical Expo 2013, Houston, Texas, 28 July - 1 August, for a meeting please contact: info@enigmadiagnostics.com 

About Enigma Diagnostics

Enigma's core mission is to provide easy to use, cost effective molecular diagnostics at the point of need. The Company specializes in developing next generation rapid molecular diagnostic instrument platforms for laboratories and decentralized point-of-need settings. Enigma's innovative and proprietary technologies combine the speed and sensitivity of real-time PCR (polymerase chain reaction) with the simplicity needed for decentralized and point-of-need testing providing results from a raw sample in less than 60 minutes. The Company is targeting a number of multi-billion pound IVD markets and certain high-value Applied Markets. Enigma's commercialization strategy is to maximize revenues from a continuous flow of market leading rapid diagnostic point-of care instrument platforms and assay panels, based on unique technologies and underpinned by its broad Intellectual Property portfolio. Enigma will partner with market leaders where global penetration of markets is required and where appropriate, will engage regional partners and build in-house sales and marketing capability to direct distribution of its products.

For more information visit http://www.enigmadiagnostics.com

About Guy's and St Thomas' NHS Foundation Trust

Guy's and St Thomas' NHS Foundation Trust is one of the UK's busiest, most successful foundation trusts, with around 1.6 million patient contacts every year. The Trust is part of the King's Health Partners, one of the first Academic Health Sciences Centres (AHSCs) in the UK and partners with:

• King's College London
• King's College Hospital NHS Foundation Trust
• South London and Maudsley NHS Foundation Trust

Guy's and St Thomas' provide a full range of hospital services for the local communities of Lambeth, Southwark and Lewisham as well as specialist services for patients from across London, the South East and further afield. It is one of the largest employers locally, with around 12,500 staff and works hard to reflect the cultural and ethnic diversity of the communities it serves.

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