Enigma initiates ML system trial in patients with influenza

Apr 11 2011

Enigma Diagnostics announced today that it has commenced clinical trials for its intended point of care Enigma® ML Influenza A/B detection assay. Enigma will submit its application to the U.S. Food and Drug Administration (FDA) for approval of the assay in 2012.  

The Enigma® ML instrument platform combines fully-automated sample extraction with real-time PCR amplification and detection system which has been specifically designed for the particular needs of infectious disease testing. The starting material for analysis is a capped tube containing universal transport medium and a swab which uniquely is inserted directly into the consumable cartridge. The test is anticipated to take less than 1 hour to perform and results are displayed in a number of simple to interpret formats by the integrated touch-user interface screen. Current methods for viral detection often require many manipulative steps for sample handling and subjective interpretation from highly-skilled laboratory technicians which can take several days to process from the time of collection. The Enigma® ML system was specifically designed as a rapid fully automated system enabling "raw sample to result" testing with uncomplicated read-outs and allowing for lower technical skill users.

Clinical trial site initiations and the enrollment of subjects for the US based trial began in late March after Enigma worked closely with the FDA on the clinical trial design for both 510(k) clearance and potential CLIA-waiver of the system.  Up to 8 clinical study sites across the United States will participate in patient enrollment and onsite testing of the Enigma® ML system.

The clinical trial design consists of two phases.  The first phase includes the collection of nasopharyngeal samples at the end of the 2010-2011 flu season.  The second phase will include additional collection of samples alongside testing on the Enigma® ML system during the 2011-2012 flu season.  A total of 1,100 subjects including both adult and pediatric patients will be enrolled in the trial.

John McKinley, Chairman and CEO, said, "It is estimated that over 12 million influenza tests are performed yearly in the USA and typically between 5 and 20 percent of the US population are infected with seasonal flu every year. Faster and more accurate tests are needed to satisfy this growing market and the features of the Enigma® ML instrument make it ideally suited to meet this demand. With increasing market recognition of the importance of achieving CLIA Waiver, we are pressing ahead with the clinical trials and anticipate completion of our EU and USA regulatory accreditation processes within 2012 to include FDA consideration of the appropriateness of the Enigma® ML system to achieve CLIA Waiver status."