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Cepheid Receives FDA Clearance and CLIA Waiver for Xpert® Xpress Flu Test

Cepheid announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance and Clinical Laboratory Improvement Amendments (CLIA) waiver for the Xpert® Xpress Flu test. The test can be performed in near-patient settings, providing rapid and accurate molecular detection of Flu A and B RNA from patient specimens, in as little as 20 minutes.1

The Xpert Xpress Flu test is also indicated for use with nasal swabs, in addition to nasopharyngeal (NP) swabs. Nasal swab collection is less invasive than NP swabs and allows for a more comfortable specimen collection experience for the patient.

"Our Xpert Xpress family of tests is designed to provide rapid results paired with uncompromising performance. They offer an easy-to-use format that delivers actionable results at the point of patient impact," said David H. Persing, M.D., Ph.D., Cepheid's Chief Medical and Technology Officer. "Xpert Xpress Flu is the first highly sensitive PCR test on a CLIA waived multi-module system designed for greater surge capacity and menu versatility."

According to the World Health Organization, infections of the upper respiratory tract represent the most common reason for antimicrobial use. The vast majority of such infections are of viral origin and do not require treatment with antimicrobials.2 "Xpert Xpress Flu provides medically actionable and timely information to clinicians to support improved patient management, and antibiotic and antiviral stewardship," continued Dr. Persing.

The new GeneXpert® Xpress Systems and Xpert Xpress Flu test extend access to standardized molecular testing for any healthcare setting — from community hospitals to physician offices and specialty clinics for no-compromise speed, accuracy, and quality. Xpert Xpress Flu utilizes automated real-time reverse transcription polymerase chain reaction (RT-PCR) to detect Influenza A and B RNA. The tests capability to detect multiple segments of RNA improves strain coverage and prevents loss of sensitivity as natural variations (antigenic drift and shift) of the Influenza virus occur. The built-in reagents deliver high accuracy in an automated format with no additional confirmation testing required.

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