Curetis said it plans to file a 510(k) submission to the FDA for its Unyvero System in 2014. The test employs polymerase chain reaction technology to isolate, amplify and identify DNA for bacteria and antibiotic resistance. To prepare for the filing, the company has initiated a clinical trial for the system and its lower respiratory tract application. The company is working on a second Unyvero application for implant and tissue infections, and on cartridges for conditions including bloodstream infections.
Published in Brief: