CE Mark for Enigma's Multiplexed Assay Detecting Influenza A, Influenza B and RSV
The Enigma® ML system and its first FluAB-RSV diagnostic assay conforms with the requirements of the IVD Directive 98/79/EC. The Enigma ML system uniquely combines a number of features critical to PoC testing. The fully automated raw sample to result instrument platform delivers results equivalent to central laboratory standards in up to 70 minutes, harnessing the speed and sensitivity of real-time PCR with both simple and highly multiplexed assay formats.
Its ease of use allows minimal training and has shown nil operator variance in trials, a major issue for other laboratory based diagnostic instruments where testing is undertaken by different operators. Together, these features will offer physicians a paradigm shift in their ability to make fully informed treatment decisions and fast and accurate diagnosis and treatment of patients.
The FluAB-RSV test can detect all currently circulating influenza and RSV viruses from nasopharyngeal swab samples, all tested in a single tube. Enigma is currently undertaking performance evaluation to extend the CE mark to other sample types for this test. In addition, Enigma is developing a pipeline of deeply multiplexed assays for the Enigma ML including panel tests for respiratory viruses, MDR-TB, and a wide range of other sexual diseases and hospital acquired infections.
Enigma’s respiratory assays will target the increasing global influenza testing market where over 12 million influenza tests are undertaken annually. With fast and accurate testing ability, the Enigma ML will first market its assays in over 30 countries accepting CE marking and will then develop tests for the US FDA and other regulatory regimes, establishing leadership in global PoC testing.
Tags: Respiratory Syncytial Virus
Date Published: February 3, 2014
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