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Enigma Wraps Up EU-Funded Consortium to Develop Seasonal Flu MDx

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Enigma Diagnostics said this week that it has successfully completed a three-year project under a European Commission Seventh Framework grant to develop a rapid, fully automated molecular diagnostic system and test for seasonal influenza.

Enigma, based in Oxford, UK, and with offices in San Diego, coordinated a consortium called Ranger that began in July 2008 under a €3 million ($4.3 million at the time) grant from the Seventh Framework Programme.

The concluding meeting of the Ranger consortium was held June 30 at Enigma's Oxford site, where the company demonstrated the use of its Enigma ML system to conduct an automated, cartridge-based, sample-to-result real-time PCR assay for circulating strains of influenza A and B in less than 60 minutes using patient samples collected with a nasopharyngeal swab.

Other members of the Ranger consortium included the UK Health Protection Agency, which was responsible for assay development; Sagentia, which supported development of the prototype Engima ML system; and Queen Sirikit National Institute of Child Health, which collected samples for clinical trials.

The Enigma ML platform uses electric conducting polymer technology originally designed for Enigma's FL platform for the defense and veterinary markets, but repurposed for infectious disease testing by relatively unskilled workers.

In April, Enigma CEO John McKinley said that the company has commenced clinical trials in the US for the influenza A and B test on the Enigma ML. The trials are being conducted at as many as eight undisclosed sites across the US, and will enroll a total of 1,100 adult and pediatric patients (PCR Insider, 4/14/11).

In a statement this week, McKinley said that "Enigma and all of the Ranger consortium recognize the valuable contribution of the EU Commission in supporting the successful development of the Enigma ML system. This has progressed from initial design concept to pre-clinical assessment of the seasonal influenza test … earlier this year. The Enigma ML system will now move to the commercialization stage during 2012."

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