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Enigma Dx Begins Clinical Trials for Flu Test on Integrated MDx Platform

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By Ben Butkus

Enigma Diagnostics said this week that it has commenced clinical trials in the US for its first diagnostic assay, a real-time PCR-based point-of-care test for influenza A and B.

Enigma will go it alone, however, as the company confirmed that it is no longer commercializing its test, the Enigma ML Influenza A/B detection assay, in partnership with GlaxoSmithKline as was previously reported.

According to Engima, clinical trial site initiations and subject enrollment began last month in the US after the company worked with the US Food and Drug Administration on the clinical trial design for both 510(k) clearance and potential CLIA waiver of the system.

As many as eight undisclosed sites across the US will enroll a total of 1,100 adult and pediatric patients for the study, and will conduct onsite testing of the Enigma ML. The trial consists of two phases: First, technicians will collect nasopharyngeal samples at the end of the 2010-2011 flu season; and then again during the 2011-2012 flu season while conducting testing on the Enigma ML.

"With increasing market recognition of the importance of achieving CLIA waiver, we are pressing ahead with the clinical trials and anticipate completion of our [European Union] and US regulatory accreditation processes within 2012 to include FDA consideration of the appropriateness of the Enigma ML system to achieve CLIA waiver status," Enigma Chairman and CEO John McKinley said in a statement.

In an e-mail to PCR Insider, a company spokesperson added that "the process for obtaining CE marking will be run in parallel with the trial work undertaken for the FDA accreditation. We are looking to achieve CE marking for our Influenza A/B assay during 2012. It must be understood that all applications for regulatory approval are within a controlled process and no guarantee can be provided of any such approval occurring or as to timing."

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 platform builds on electric conducting polymer, or ECP, technology used in 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.

For instance, the test uses a capped tube containing a universal transport medium into which the sample – a nasopharyngeal swab, in the case of the flu test – is inserted. The tube is then placed directly into a consumable cartridge, which is in turn inserted into the Enigma ML instrument.

Enigma said that the test is anticipated to take less than one hour to perform and that results will be displayed in a number of "simple-to-interpret" formats through an integrated touch-screen interface. The company has previously said that it will aim for the lowest complexity CLIA waiver so that the platform can be used across all decentralized laboratories and testing centers.

In July 2009, Enigma inked a worldwide agreement with GlaxoSmithKline to develop the Enigma ML Influenza A/B test, and said that it anticipated prototype testing in Europe in the fourth quarter of 2009 and commercial launch of the platform in early 2011, subject to successful clinical trials and regulatory approval.

Then, 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).

Most recently, in January, Enigma said that it had expanded its agreement with Tecan to enable the partners to develop a fully integrated, PCR-based molecular diagnostics platform for an undisclosed third party in the molecular testing space. However, McKinley also said at the time that commercial launch of the Enigma ML had been delayed until sometime later this year due to "previously unforeseen changes in the manufacturing and supply chain" for the instrument (PCR Insider, 1/13/11).

Now, it appears that commercial launch will be delayed again, as Enigma is just beginning clinical trials for the instrument. In addition, an Enigma spokesperson confirmed that the platform is no longer being developed in partnership with GSK; rather, it is being developed "independently by Enigma."

A GSK spokesperson declined to comment on the status of the partnership.


Have topics you'd like to see covered in PCR Insider? Contact the editor at bbutkus [at] genomeweb [.] com.

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