Influenza Detection Assay Inaugurated for Clinical Trials

The instrument platform combines fully automated sample extraction with real-time polymerase chain reaction (PCR) amplification and detection system that 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 nasopharyngeal swab, which uniquely is inserted directly into the consumable cartridge. The test is anticipated to take less than one 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 Mini-Laboratory (ML) Influenza A/B detection assay is produced by Enigma Diagnostics Limited, (Porton Down, UK). 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 US Food and Drug Administration, (FDA; Silver Springs, MD, USA) on the clinical trial design for both 510(k) clearance and potential Clinical Laboratory Improvement Amendments-(CLIA) waiver of the system. Up to eight clinical study sites across the US will participate in patient enrollment and onsite testing of the Enigma ML system.

John McKinley, Chairman of Enigma Diagnostics, said, "It is estimated that over 12 million influenza tests are performed yearly in the USA and typically between 5% and 20% 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."

Related Links:
Enigma Diagnostics Limited
US Food and Drug Administration