Enigma Diagnostics Announces Successful Evaluation Of The Enigma FL By The UK's Veterinary Laboratories Agency

Main Category: Veterinary
Also Included In: Infectious Diseases / Bacteria / Viruses;  Medical Devices / Diagnostics;  Regulatory Affairs / Drug Approvals
Article Date: 01 Jul 2009 - 1:00 PDT

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Enigma Diagnostics Limited, the decentralised and point-of-care molecular diagnostics company, announced successful independent testing for bovine viral diarrhoea (BVD) by the Veterinary Laboratories Agency to evaluate the performance of the Enigma FL (Field Laboratory).

BVD is considered to be one of the main threats to cattle (1), affecting the majority of herds in the UK. It is closely related to classical swine fever virus, a serious disease of pigs, and to border disease virus, which infects sheep.

The Enigma FL instrument was used to analyse more than 100 blood samples that had already been screened by antigen ELISA and a laboratory-based RT-PCR for the presence of the BVD virus. Approximately half of the samples were proved BVDV positive by the laboratory-based PCR. With the level of concordance between the two tests being above 97%, this confirmed the Enigma FL system can produce laboratory-standard results with a high degree of confidence.

The Enigma FL has been designed for easy operation. Tests are provided in a single-use cartridge that can be stored at room temperature. The Enigma FL provides a PCR result in less than one hour, a timescale needed to allow field-based & pen-side diagnosis. On-site testing removes delays from transport of samples to the laboratory, which can often take days. The system requires minimal training and its utility for "pen-side" testing for BVD has already been demonstrated.(2)

John McKinley, Chairman and CEO of Enigma, stated: "The Enigma Diagnostics tests could be deployed for the related viral diseases, such as classical swine fever, with minor modifications. The system itself is broadly applicable to many other veterinary pathogens, such as TB in cattle, bacterial infections and other viral infections, such as foot and mouth disease and avian influenza. Allowing vets to use advanced molecular diagnosis in the field will enhance their efficiency in managing endemic and exotic disease outbreaks identifying diseased animals and as importantly, non-infected ones and improve their surveillance capability."

About Enigma Diagnostics Limited

Enigma Diagnostics Limited is a private UK based company specialising in developing the next generation of rapid molecular diagnostic instrument platforms for decentralised and point-of-care settings.

Enigma's innovative and proprietary technology combines the speed and sensitivity of real-time PCR (polymerase chain reaction) with the simplicity needed for field-based, decentralised and point-of-care tests providing results from a raw sample in less than 45 minutes.

The Company is targeting a number of multi-billion pound markets, core among which are the Clinical and high value Applied Markets. Enigma's commercialisation strategy is to maximise revenues from a continuous flow of market leading rapid diagnostic point-of care and in-field instrument and assay platforms, derived from its broad Intellectual Property portfolio of issued and filed patents. Enigma will partner with market leaders where global penetration of markets is required and where appropriate will build an in-house sales and marketing capability to direct distribution of its products.

Enigma has an exclusive licence from the Defence Science and Technology Laboratory to a portfolio of patents, which represent over 15 years of UK Ministry of Defence funded research and has licences from Applied Biosystems and Celera Licences for the commercialisation of real-time PCR instruments. Enigma's R&D activities have generated a portfolio of over 50 plus worldwide patent families dedicated to real-time PCR and wider molecular technologies. Many of these patents are granted across a range of core commercial territories including US, EU and Japan with more extensive filing and grants across a number of other key territories.

Source: Enigma Diagnostics Limited