NEW YORK (GenomeWeb News) – Enigma Diagnostics today said that it plans to seek regulatory approval in the US for its molecular influenza assay in 2012.
In support of its submission, the company has started clinical trials for its point-of-care Enigma ML Influenza A/B detection assay.
Clinical trial site initiations and enrollment began late last month after the UK firm met with FDA about clinical trial design for both 510(k) clearance and CLIA certification of the test. Up to eight clinical study sites across the US will participate in patient enrollment and onsite testing of the Engima ML system, with a total of 1,100 subjects, made up of both adult and pediatric patients, to be enrolled in the trial.
The instrument platform combines fully automated sample extraction with real-time PCR amplification and detection, and is specifically designed for the specific demands of infectious disease testing. The test, Enigma said, is engineered for ease of use and to achieve results in less than one hour, compared to the many manipulative steps for sample handling required for current methods of viral detection, as well as a time lag for results that can stretch into days.
According to John McKinley, chairman and CEO of Enigma, more than 12 million influenza tests are done in the US each year and between five and 20 percent of the 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," McKinley said.
Among competitors that currently offer molecular assays for Influenza A and B are Gen-Probe, Nanosphere, and Quest Diagnostics.