www.fdanews.com/articles/175239-atlas-genetics-nabs-ce-mark-for-chlamydia-test
Atlas Genetics Nabs CE Mark for Chlamydia Test
February 8, 2016
Atlas Genetics has received approval to CE Mark its Chlamydia trachomatis test to be launched on the company’s io platform.
The product is the first molecular point-of-care test for a sexually transmitted infection to enter the market, capable of delivering test results in just 30 minutes, the company said.
The evaluations conducted on the io CT test demonstrated that its 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, Atlas said. — Jonathon Shacat