Atlas molecular STD point-of-care test gets EU approval
February 8, 2016 – BATH. Atlas Genetics Ltd announced 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.”
Source: Atlas Genetics