Roche Receives FDA Clearance for Strep A Test on cobas Liat System

Roche today announced that the U.S. Food and Drug Administration (FDA) has provided 510(k) clearance for the cobas Strep A test for the detection of group A streptococcus bacterial (Strep A) DNA in throat swab specimens. The cobas Strep A test runs on the cobas Liat System, a molecular point of care diagnostic system, which will be launched later this year. With a time to result of just 15 minutes, the cobas Strep A test achieves outstanding sensitivity aiding healthcare professionals to make immediate, informed treatment decisions in a variety of testing locations.
Source: Roche Investor Update - Category: Pharmaceuticals Source Type: news