The FDA has granted de novo clearance of the first molecular diagnostic test for lower respiratory tract infections, according to the manufacturer of the device.
The Unyvero System and Unyvero LRT application cartridge, manufactured by Curetis, can deliver test results from aspirate samples in less than 5 hours, the company said. It can detect more than 30 gram-positive and gram-negative bacteria, along with 10 genetic markers for antibiotic resistance.
“The launch of our Unyvero System and LRT application cartridge in the United States will address a pressing unmet medical need as it delivers results much faster than current standard-of-care microbiology culture,” Curetis co-founder and Chief Operating Officer Johannes Bacher said in the release.
A clinical trial of the Unyvero test included more than 2,200 patient samples from nine U.S. hospitals. The company announced plans to roll out the test in the U.S. early in the second quarter.
Disclosure: Bacher is a co-founder and COO of Curetis.