Enigma Diagnostics said this week that it has received CE IVD marking for its Enigma ML system and first assay, a combined molecular test for influenza A/B and respiratory syncytial virus.
The CE mark is an important milestone for Salisbury, UK-based Enigma, which has been developing the Enigma ML (Mini Laboratory) — a real-time PCR-based point-of-care testing platform — since at least 2009. Enigma said that it will now begin marketing its system and FluAB-RSV assay in more than 30 countries recognizing the CE mark.
The Enigma ML is a fully automated, integrated, and testing system that features similar technology to that used in the company's Enigma FL (field laboratory) platform, which it designed in collaboration with the UK Ministry of Defense and launched in November 2008 for field-based testing in the veterinary and defense markets.
Enigma has an exclusive license from the UK's Defence Science and Technology Laboratory to a portfolio of patents representing more than 15 years of Ministry of Defense-funded work; as well as a portfolio of more than 50 patent families worldwide protecting innovations made through its own internal R&D activities, the company claims. Enigma has also noted in the past that it has obtained freedom to operate in the diagnostic and applied markets from key real-time PCR patent holders Life Technologies and Roche.
Key technologies comprising the Enigma ML platform include an electric-conducting polymer for ultra-fast thermal cycling and so-called ResonSense linear probes for rapid fluorogenic PCR. The system can deliver results that are equivalent to central laboratory standards from raw sample in about 70 minutes, and is capable of performing both simple and multiplexed assays. Enigma also claims that the platform requires minimal operator training and has shown no operator variance in trials.
The company's new FluAB-RSV test can detect all currently circulating influenza and RSV viruses from nasopharyngeal swab samples tested in a single tube. Enigma is currently evaluating the assay's performance in order to extend the CE mark to other sample types.
Enigma completed clinical validation of the FluAB-RSV assay in August in collaboration with Guy's and St. Thomas' National Health Service Foundation Trust. The company said at the time that it had installed an undisclosed number of ML instruments at Guy's and St. Thomas' for use at the Trust's Centre for Clinical Infection and Diagnostics Research.
During May and June 2013, several hundred clinical samples obtained by Enigma from patients in Africa with symptoms of respiratory disease were processed on the Enigma ML and compared with data from the Luminex xTAG respiratory viral panel, showing comparable sensitivity and specificity between the two systems.
The company said that Enigma ML achieved both negative predictive and positive predictive values of 100 percent for the Flu B and respiratory syncytial virus components of the assay, and negative and positive predictive values of 97 percent and 100 percent, respectively, for the Flu A component of the assay.
In addition to the FluAB-RSV test, Enigma said it is developing a pipeline of "deeply multiplexed assays" for the Enigma ML including panel tests for respiratory viruses, multidrug-resistant tuberculosis, sexually transmitted diseases, and hospital-acquired infections.
Although Enigma will first market the Enigma ML and related assays in regions recognizing the CE mark, it said that it plans to eventually develop tests to submit for clearance by the US Food and Drug Administration and other regulatory bodies.
The road to market for Enigma's platform has been bumpy. In 2009 the company inked an agreement with GlaxoSmithKline to develop a point-of-care molecular test for influenza using the system. Under that agreement, GSK was to make a small, undisclosed equity investment in Enigma and provide it with an upfront payment, research and development funding, milestone payments, and profit sharing on sales of products developed under the collaboration.
Then, in February 2010 Enigma had announced a five-year global manufacturing and supply agreement with Tecan to produce the ML instrument in anticipation of a Q4 2010 launch of the instrument with GSK — a target date that was never met.
In April 2011 Enigma said that it had commenced clinical trials in the US for an influenza A/B assay running on the Enigma ML, but noted that it was undertaking these trials on its own.
However, those clinical trials apparently have not yet panned out, and in 2011, Enigma and GSK updated their agreement to focus on commercial efforts outside the US. Under that new agreement, Enigma was to develop an initial range of respiratory infectious disease tests for the Enigma ML, and GSK would retain exclusive marketing rights for the tests in Europe and some non-European countries such as India, Brazil, and Russia. GSK also made an undisclosed equity investment in Enigma and agreed to provide the company with R&D-related payments, royalties based on net sales of resulting test products, and future milestone payments.
The current status of the GSK agreement is unclear. Neither Enigma nor GSK returned a request for comment prior to the publication of this article.
However, in a statement this week, John McKinley, chairman of Enigma, remarked that the company is "in the last stages of finalizing our global commercialization partnership strategy and our assay pipeline will be delivered in collaboration with a number of eminent reference laboratories and commercialization partners in Europe and other regional markets."