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

Accurate and Reliable Group A Streptococcus Detection in as Little as 18 Minutes1

SUNNYVALE, CALIF. — May 2, 2018 — Cepheid announced today 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 as 18 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.

For more information on Cepheid's GeneXpert® Systems or the complete menu of Xpert and Xpert Xpress tests, visit www.cepheid.com.

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1. With early assay termination (EAT) for positive results

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About Cepheid

Based in Sunnyvale, Calif., Cepheid is a leading molecular diagnostics company dedicated to improving healthcare by developing, manufacturing, and marketing accurate yet easy-to-use molecular systems and tests. By automating highly complex and time-consuming manual procedures, the company’s solutions deliver a better way for institutions of any size to perform sophisticated genetic testing for organisms and genetic-based diseases. Through its strong molecular biology capabilities, the company is focusing on those applications where accurate, rapid, and actionable test results are needed most, such as managing infectious diseases and cancer. For more information, visit http://www.cepheid.com.