Atlas Genetics Gains EU CE Approval for First Product
Approval of Chlamydia test for marketing and sale in Europe
Atlas Genetics Ltd, the Bath, UK based, 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.