Cepheid Receives FDA Clearance and CLIA Waiver for Xpert Xpress Strep A

Cepheid announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance and waiver under the Clinical Laboratory Improvement Amendments (CLIA) for the Xpert® Xpress Strep A test. The test can be performed in near-patient settings by untrained users, to provide rapid and accurate molecular detection of Streptococcus pyogenes (i.e., Group A Strep) in as little as18 minutes.1

"The rapid results provided by Xpert Xpress Strep A test can facilitate antimicrobial stewardship in the outpatient setting consistent with renewed healthcare provider focus on the reduction of unnecessary antibiotic use in ambulatory care settings. It also leverages the versatility of our platform to improve patient care," said David H. Persing, M.D., Ph.D., Cepheid's Chief Medical and Technology Officer.

Xpert Xpress Strep A utilizes automated real-time polymerase chain reaction -PCR- to detect Streptococcus pyogenes DNA. The on board reagents deliver high-performance specifications with no requirements for culture confirmation of negative results unless clinical symptoms persist or there is an outbreak of acute rheumatic fever.