Healthcare Industry News: IPLEX
News Release - February 8, 2016
Atlas Genetics Gains CE Approval for First ProductApproval of Chlamydia test for marketing and sale in Europe
BATH, England, February 8, 2016 -- (Healthcare Sales & Marketing Network) -- Atlas Genetics Ltd ("Atlas Genetics" or the "Company"), the ultra-rapid Point-Of-Care (POC) molecular diagnostics company, today announces that it has received approval to CE Mark its Chlamydia trachomatis (CT) test to be launched on the Company's ioŽ platform. By meeting the requirements of the IVD Directive (98/79/EC), the CT test is now cleared for sale within the European Union.
The launch of the ioŽ CT test signals a new era in ultra-rapid molecular diagnostics. This is the first molecular POC test for a Sexually Transmitted Infection (STI) to enter the market, capable of delivering test results in just 30 minutes. With the speed and accuracy of the ioŽ CT product, the testing and treatment of patients within a single, brief visit to the clinic now becomes a reality.
The evaluations conducted on the ioŽ CT test demonstrated that performance is equivalent to the gold standard laboratory test and will not be compromised by the transition of testing away from the central laboratory to the POC setting, or by the level of experience of the operator performing the test. The benefit of the ioŽ platform is to provide a rapid result, delivered immediately to the patient which has the potential to improve patient outcomes, decrease onward transmission and reduce healthcare costs.
The Chlamydia test is the first in a pipeline of tests to be launched on the ioŽ platform. Further menu development will include tests for Gonorrhoea, Trichomonas vaginalis and other STIs, for both the European and US markets. Whilst Atlas's commercialisation strategy is initially focused on the area of sexual health, the ioŽ platform technology can be applied in a wide range of infectious disease and oncology diagnostic test areas.
John Clarkson, CEO of Atlas Genetics, said: "This is a major milestone for Atlas Genetics and marks the beginning of the next phase of growth for Atlas as we move to commercialise our first product and expand the ioŽ infectious disease menu of tests. STIs are on the rise and the faster a diagnosis can be made, the faster treatment can be given, not only benefiting the patient but also saving time and money. We believe that our ioŽ platform will play a key role in the future of STI diagnosis."
Atlas Genetics Ltd (http://www.atlasgenetics.com)
Atlas Genetics develops ultra-rapid point-of-care (POC) diagnostic tests for infectious diseases. The Atlas Genetics ioŽ system uses patented technology based on the use of a novel electrochemical sensor that combines speed, accuracy and multIPLEX detection capability. The Company has its head office and R&D facilities near Bath in the UK, with a commercial office in Boston, USA.
Investors in Atlas Genetics include Novartis Venture Funds, Johnson & Johnson Innovation - JJDC, Inc., Consort Medical plc, BB Biotech Ventures, LSP, RMI Partners, Technology Venture Partners and private investors.
Source: Atlas Genetics
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