GlaxoSmithKline (GSK) and Enigma Diagnostics Limited have announced an agreement to develop and supply the first point-of-care diagnostic test to identify specific influenza virus strains.
GSK and Enigma will develop the test with the Enigma ML mini laboratory using the real-time polymerase chain reaction (PCR) technology platform, which is capable of delivering fully automated results from swab samples in less than 60 minutes with the same accuracy standards as reference laboratories.
The system will speed up treatment for patients, who often have to wait several days before the results of government laboratory tests are available.
A trial of the ML system across Europe will commence in Q4 2009. Launch of Enigma ML is anticipated in early 2011, subject to successful clinical trials and regulatory approval.
GSK European Pharmaceuticals business president Eddie Gray said that the technology is 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.
“This 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,” Gray said.
As part of the agreement, GSK will make a small equity investment in Enigma. The deal also includes an upfront payment, research and development funding and profit sharing on sales. Further payments will be subject to development progress and agreed milestones.