Healthcare Industry News: U.S. Food and Drug Administration
News Release - July 26, 2018
Cepheid Receives FDA Clearance and CLIA Waiver for Xpert(R) Xpress Flu/RSV TestRespiratory Infection Results in as Little as 20 Minutes(1)
SUNNYVALE, Calif., July 26, 2018 -- (Healthcare Sales & Marketing Network) -- Cepheid announced today that 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/RSV test. The test can be performed in near-patient settings, providing rapid and accurate molecular detection of influenza A and B viruses, and RSV RNA from patient specimens in as little as 20 minutes.1
In addition to nasopharyngeal (NP) swab specimens, the Xpert Xpress Flu/RSV test is indicated for use with nasal swabs. Nasal swab collection is less invasive than NP swabs are and allows for a more comfortable specimen collection experience for the patient.
"Reflecting on the enormous impact of the last flu season, we are pleased to announce the launch of Cepheid's third CLIA-waived respiratory test: Xpert Xpress Flu/RSV. Our family of CLIA-waived Xpert Xpress tests allows laboratories to expand their capacity by extending standardized testing for flu, RSV, and Strep A to near-patient and point-of-care settings. Our first-in class multi-module system deals effectively with the surge of tests demanded by a severe flu season and frees up the laboratory to conduct other more complicated tests," said David H. Persing, M.D., Ph.D., Cepheid's Chief Medical and Technology Officer.
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/RSV, Flu, and Strep A tests provide medically actionable and timely information to clinicians to support improved patient management, and antibiotic and antiviral stewardship," continued Dr. Persing.
Xpert Xpress Flu/RSV utilizes automated real-time reverse transcription polymerase chain reaction (RT-PCR) to detect influenza A, influenza B, and RSV RNA. The test's 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 onboard reagents deliver high-performance specifications 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.
Based in Sunnyvale, Calif., Cepheid is a leading molecular diagnostics company that is 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.
1. With early assay termination (EAT) for positive Flu or for positive RSV only. Reporting negatives and combined Flu and RSV results in 30 minutes.
2. World Health Organization. Upper respiratory tract infections. Accessed June 2018. http://apps.who.int/medicinedocs/en/d/Js5406e/3.html
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