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GSK to Market Enigma Diagnostics' POC Respiratory Disease Tests Under New Pact

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Enigma Diagnostics and GlaxoSmithKline said today that they have signed a supply and commercialization agreement for molecular diagnostic tests for use on Engima's fully automated, sample-to-answer real-time PCR system, breathing new life into a partnership begun in 2009.

Under the agreement, Oxford, UK-based Enigma will develop an initial range of respiratory infectious disease tests for use on its Enigma ML platform, which is still under development. GSK will retain exclusive marketing rights for the tests in Europe and some non-European countries such as India, Brazil, and Russia.

In addition, the companies said that GSK will have the opportunity to "generate revenues from further test developments in infectious diseases and in other therapeutic areas relevant to its healthcare business."

In return, GSK is making an up-front equity investment in Enigma, providing it with R&D-related payments and royalties based on net sales of resulting test products, and providing milestone payments in the future. Financial terms of the agreement were not disclosed.

The agreement expands the scope of a previously announced partnership between the companies announced in July 2009, which focused on the development of a point-of-care molecular test for influenza A and B.

Under that agreement, GSK was to make a small, undisclosed equity investment in Enigma and provide it with an upfront payment, research and development funding, milestone payments, and profit sharing on sales of products developed under the collaboration.

In February 2010, Engima announced a five-year global manufacturing and supply agreement with Tecan to produce the ML instrument in anticipation of a Q4 2010 launch of the instrument with GSK (PCR Insider, 2/11/10)

Earlier this year, however, the nature of the Enigma-GSK flu testing agreement changed as Enigma said that it had begun clinical trials in the US for the influenza A/B test, but that it was doing so independently of GSK (PCR Insider, 4/14/11).

With the new agreement it would appear that Enigma and GSK have come to terms on an updated agreement broadly covering respiratory infectious diseases testing. Enigma did not say whether the influenza test is covered under the new agreement with GSK. Company officials declined to comment.

The Enigma ML is a fully automated PCR-based detection system with integrated sample preparation that the company has been developing for several years. The Enigma ML uses the same electric conducting polymer, or ECP, technology as the company's Enigma FL platform for the defense and veterinary markets, but is specifically designed for infectious disease testing, particularly by relatively unskilled workers.

According to Enigma the ML system will be able to deliver a test result from a raw sample in less than one hour.

"This is a major collaboration and represents a significant milestone for Enigma," Enigma Chairman and CEO John McKinley said in a statement. "These agreements for assay development, commercialization, and supply will leverage GSK's extensive sales and marketing force with Enigma's unique point-of-care system which has potential uses across a number of human diseases."

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