GSK and Enigma Diagnostics announce commercial partnership to develop point-of-care influenza diagnostics
London UK -- GlaxoSmithKline (GSK) and Enigma Diagnostics Limited today announced that they have signed worldwide agreements to develop and supply the first point-of-care diagnostic influenza tests to identify specific influenza virus strains using its real-time Polymerase Chain Reaction (PCR) technology platform, the Enigma ML (Mini Laboratory).
The partnership will enable GSK and Enigma to develop the Enigma ML to deliver fully-automated results from swab samples in less than 60 minutes at the point of care and to the same accuracy standards as reference laboratories. This will mean that patients can be tested for specific influenza subtypes in the community and receive appropriate treatment rapidly. Currently the existing network of government diagnostic laboratories, staffed by specialist operators, can often take several days before the results of tests are known. Operators of the Enigma ML system will not require specialist training.
A trial involving working prototypes of the ML system with front line health care providers across Europe will commence in Q4 2009. Launch of Enigma ML is anticipated in early 2011, subject to successful clinical trials and regulatory approval.
Eddie Gray, President of GSK’s European Pharmaceuticals Business said “GSK is doing everything it can to help governments and healthcare professionals tackle influenza effectively. This technology is very promising and has the potential to ensure that patients are diagnosed accurately and rapidly and that they receive the most appropriate treatment in a timely manner. It could also play a key part in enabling governments to support critical workers to fulfil their roles during a pandemic as well as facilitate sensitive influenza surveillance – key to the identification of novel strains and optimal utilisation of antiviral medication.”
John McKinley, Chairman and CEO of Enigma, said: “The partnership between Enigma and GSK enables significant progression towards the ‘holy grail’ of companion diagnostics – the ability to rapidly and locally test to the same accuracy standards as reference laboratories and immediately determine the correct treatment. This is without doubt one of the most significant clinical diagnostics partnerships to have been formed with Enigma. An accurate ‘test and treat’ capability offers the healthcare community an effective weapon to fight flu as the virus evolves. This is not only a significant step forward for flu but for other areas such as infectious disease management, where the ML system can also be used effectively.”
Under the terms of the agreement, GSK will make a small equity investment in Enigma, an upfront payment, research and development funding and profit sharing on sales. Further payments will be subject to development progress and agreed milestones.
Notes to Editors
The Polymerase Chain Reaction technology (PCR) is a widely used & highly specific diagnostic technique in which a few copies of target DNA are amplified to generate millions of copies of the specific DNA sequence making it easier to identify the sample.
GlaxoSmithKline – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com
About Enigma Diagnostics Limited
Enigma Diagnostics Limited specialises in developing next generation 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 decentralised and point-of-care testing providing results from a raw sample in less than 60 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 maximize revenues from a continuous flow of market leading rapid diagnostic point-of care instrument and assay platforms, 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.
Enigma has an exclusive license from the Defence Science Technology Laboratory to a portfolio of patents, which represent over 15 years of UK Ministry of Defence funded Research. It also has licences from Applied Biosystems and Celera Diagnostics for commercialization of real-time PCR instruments, and from Roche Molecular Systems to practice HybProbe real-time PCR chemistry for human and veterinary in vitro diagnostics. 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.
Enigma majority shareholder is Porton Capital, a private equity house which has supported Enigma’s development since incorporation in 2004.
For more information visit www.enigmadiagnostics.com
This press release is intended for business journalists and analysts/investors. Please note that this release may not have been issued in every market in which GSK operates.
Cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK’ s operations are described under ’Risk Factors’ in the ’Business Review’ in the company’ s Annual Report on Form 20-F for 2008.
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