CE Approval for Atlas Genetics POC Chlamydia Test
Atlas Genetics Ltd has received it's first approval, CE Marking of 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.
Designed to meet CLIA Waiver, the platform comprises of a small, low cost, easy-to-use instrument (the io™ Reader) and a test-specific disposable cartridge (the io™ Cartridge) specifically designed for use in decentralised laboratories, point-of-care and other near-patient settings, providing a laboratory accurate test result in around 30 minutes.
Atlas’ proprietary electrochemical detection method in conjunction with the design of the io™ Cartridge enables multiplexing of up to 24 tests in one cartridge.
Watch the video of how it works on YouTube
Date Published: 1st March 2016
Source article link: Atlas Genetics