Enigma Diagnostics has already demonstrated feasibility testing of a single tube assay that can identify and differentiate human and bovine TB in an earlier trial, funded by an initial grant from the Technology Strategy Board’s Biomedical Catalyst programme. The multi-drug resistant tuberculosis (MDR-TB) assay also detects all mutations responsible for Rifampicin and Isoniazid resistance.
The grant of £1.4m was awarded to a consortium led by Enigma Diagnostics which includes the Clinical TB Research Laboratory, London, headed by Prof. F Drobniewski and Health Sciences Research Ltd. Enigma will focus on further development of the MDR-TB assay and fully automated sample preparation for use on Enigma’s flagship Mini Laboratory (ML) system.
The Enigma® Mini Laboratory system uniquely combines a number of features critical to PoC testing. The fully automated raw sample to result instrument platform delivers results equivalent to central laboratory standards in up to 70 minutes and can be used by non-technical users in both laboratory and decentralised settings. With this assay, the ML system will be particularly appropriate for use in developing countries and in resource-poor areas where multi-drug resistant tuberculosis is an ever-increasing problem. The ML system’s ease of use requires minimal training and has shown nil operator variance in recent trials, a major issue for other laboratory based diagnostic instruments where testing is undertaken by different operators. Together, these features offer physicians a paradigm shift in their ability to make fully informed treatment decisions and patients fast and accurate diagnosis with immediate treatment.
John McKinley, Chairman of Enigma Diagnostics, said: “With this grant, The Technology Strategy Board has recognised the importance of supporting Enigma to develop complex diagnostic assays on its ML system which can ultimately save patients’ lives. Our sophisticated multiplexing technology provides unprecedented levels of urgently required diagnostic information to clinicians working in a range of healthcare locations. We recognise MDR-TB as a significant healthcare issue and this grant will enable Enigma to broaden its commercialisation programme to include this important test.”
Integrated into the Technology Strategy Board’s Stratified Medicine Innovation Platform, the Detection & Identification of infectious agents (DIIA) platform was established in 2008 with the aim of reducing the economic burdened, death and illness due to infectious diseases in humans and animals. Projects supported under the DIIA platform have used public funding to encourage the development and adoption of clinically useful, commercially viable diagnostic solutions.
Dr Penny Wilson, who manages the programme for the Technology Strategy Board, said: “The development of clinically useful decentralised diagnostic tests for tuberculosis requires the convergence of excellence in a broad spectrum of capabilities and we are delighted to be supporting projects in this area for the benefit of economic growth and public health. We wish Enigma Diagnostics every success in rising to the challenge and look forward to following the company’s progress.”