Enigma Diagnostics Ltd, a leader in molecular diagnostic point-of-care (PoC) infectious disease testing, has declared conformity with the requirements of the IVD Directive 98/79/EC for CE Marking of its Enigma ML system and its first FluAB-RSV diagnostic assay.

The EnigmaML 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 (polymerase chain reaction) 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.

John McKinley, chairman of Enigma Diagnostics, said: "Achieving CE Mark for our Enigma ML and the FluAB-RSV test is a significant milestone for Enigma. Our FluAB-RSV assay will be quickly followed by a pipeline of multiplexed assays targeted at PoC testing and relevant to both developed and emerging healthcare regions.  We are in the last stages of finalising our global commercialisation partnership strategy and our assay pipeline will be delivered in collaboration with a number of eminent reference laboratories and commercialisation partners in Europe and other regional markets."