About Atlas Genetics’
io® system

Our pioneering, flexible diagnostic instrument and disposable cartridge system is designed for decentralised laboratory, point-of–care and other near-patient settings. It provides a fast, easy-to-use and accurate affordable solution to screening for the presence of STIs and HAIs, where rapid diagnosis is essential for effective treatment and control.

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Atlas Genetics Gains CE Approval for First Product

Approval of Chlamydia test for marketing and sale in Europe

 
Bath, UK, February 8, 2016. 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 io® 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 io® 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 io® 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 io® 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 io® 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 io® 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 io® 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 io® 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 io® platform will play a key role in the future of STI diagnosis.”

 

Contact details:

 

Atlas Genetics Ltd: Tel: +44 (0) 1225 717930
John Clarkson  
   
FTI Consulting: Tel: +44 (0) 20 3727 1000
Mo Noonan / Matthew Moss  

 

NOTES TO EDITORS

 

Atlas Genetics Ltd (www.atlasgenetics.com)

Atlas Genetics develops ultra-rapid point-of-care (POC) diagnostic tests for infectious diseases. The Atlas Genetics io® 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.

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Atlas Genetics
Derby Court 
Epsom Square 
White Horse Business Park 
Trowbridge, Wiltshire 
BA14 0XG 
United Kingdom 

 

+44 (0)1225 717930 
info@atlasgenetics.com

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