Home » Cepheid Gains FDA Clearance for Strep A Test
Cepheid Gains FDA Clearance for Strep A Test
Devices Submissions and Approvals
Cepheid, a molecular diagnostics company, received FDA 510(k) clearance for its Xpert Xpress Strep A test to provide molecular detection of Streptococcus pyogenes (Group A Strep).
The test uses an automated real-time polymerase chain reaction to detect Strep A DNA. It can be performed by untrained users to gather results in around 18 minutes.
The low-risk CLIA-waived test does not require culture confirmation for negative results unless symptoms persist or there is an outbreak of acute rheumatic fever.