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Enigma Teams with GlaxoSmithKline on Flu MDx

NEW YORK (GenomeWeb News) – UK-based molecular diagnostics startup Enigma Diagnostics has inked an agreement with GlaxoSmithKline to develop and market point-of-care influenza tests that will run on Enigma's PCR-based platform, Enigma ML.

Under terms of the worldwide development and supply deal, GSK will make a small, undisclosed equity investment in Enigma. It also will provide Enigma with an upfront payment, research and development funding, milestone payments, and profit sharing on sales of products developed under the collaboration.

The goal of the alliance is to develop tests that can identify specific influenza strains. The firms expect to develop the Enigma ML to deliver fully automated results from swab samples in less than 60 minutes at the point of care with the same accuracy as reference labs. The partners said that the Enigma ML system will not require any specialist training.

"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," Enigma Chairman and CEO John McKinley said in a statement. "This is without doubt one of the most significant clinical diagnostics partnerships to have been formed with Enigma."

A trial of prototypes of the Enigma ML system will begin in Europe in the fourth quarter of this year. Enigma anticipates launching the system in early 2011, subject to successful clinical trials and regulatory clearance.

The deal with GSK follows last week's news that Enigma had licensed two patents from Roche Molecular Systems for use in decentralized and point-of-care human and veterinary in vitro molecular diagnostics.

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