GlaxoSmithKline (GSK) and Enigma Diagnostics Limited 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.
Enigma Diagnostics Limited specialises in developing next generation rapid molecular diagnostic instrument platforms for decentralised and point-of-care settings.