Enigma Diagnostics CE marks the Enigma® ML system and its first multiplexed assay detecting Influenza A, Influenza B and RSV
SALISBURY, England, January 14, 2014 /PRNewswire/ –
Enigma Diagnostics Ltd, a leader in molecular diagnostic point-of-care (PoC)
infectious disease testing, announces that it has today declared conformity with the
requirements of the IVD Directive 98/79/EC for CE Marking of its Enigma(R) 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.”
About Enigma Diagnostics
Enigma Diagnostics is a global leader in Point-of-Care infectious disease testing.
Leveraging its extensive range of proprietary technologies and Intellectual Property, the
Company has developed the Enigma Mini Laboratory (ML) system, combining the speed and
sensitivity of real-time PCR (polymerase chain reaction) with the simplicity needed for
decentralised and Point-of-Care testing.
The Company is initially targeting the large and high growth infectious disease
markets with a strong pipeline of multiplexed assays for respiratory diseases, sexually
transmitted diseases and hospital acquired infections. The Enigma ML system benefits from
a global manufacturing and supply chain providing scalable volume manufacture, delivering
a cost base which will capture and establish leadership of developed and emerging
Point-of-Care healthcare markets.
Enigma is headquartered at Porton Down, UK. For more information visit
Press Contact: Enigma Diagnostics Limited John McKinley +44(0)7767-367193 Consilium Strategic Communications Amber Bielecka, Lindsey Neville, Ivar Milligan +44(0)207-920-2354 firstname.lastname@example.org
SOURCE Enigma Diagnostics Ltd