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

SUNNYVALE, Calif., Jan. 9, 2018 /PRNewswire/ -- Cepheid announced today 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.

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

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.

References

1. Results from negative specimens are reported in approximately 30 minutes.
2. Health Organization. Upper respiratory tract infections. Accessed December 2017. http://apps.who.int/medicinedocs/en/d/Js5406e/3.html

For Cepheid Media Inquiries:
Darwa Peterson
darwa.peterson@cepheid.com

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SOURCE Cepheid