Cepheid Announces FDA Clearance Of Xpert® Xpress Flu And Xpert Xpress Flu/RSV
Providing Rapid Molecular Diagnostic Results
in as little as 20 minutes
SUNNYVALE, Calif., Feb. 15, 2017 /PRNewswire/ -- Cepheid today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to market Xpert® Xpress Flu and Xpert Xpress Flu/RSV. Both tests deliver reference-quality molecular results in as little as twenty minutes. The tests are Cepheid's first Xpress branded products — all of which are expected to deliver results in 30 minutes or less.1
"For too long, clinicians have been asked to treat suspected cases of influenza empirically, since gold-standard RT-PCR based tests took too long to process in the critical first 24 hours of symptom onset," said David H. Persing, M.D., Ph.D., Cepheid's Chief Medical and Technology Officer. "With the arrival of fast molecular tests like Xpert Xpress Flu and Xpert Xpress Flu/RSV, patients and their healthcare providers can now expect an accurate diagnosis and have access to targeted therapies substantially more quickly. Unnecessary treatment with antimicrobial agents can also be avoided. This supports clinical efforts to improve the patient experience, and further streamlines workflow in the laboratory — which can be particularly challenging in the midst of a busy respiratory virus season."
Upper respiratory infections are among the most common reasons for outpatient visits in the United States and worldwide.2,3 Early symptoms for a wide variety of viral and bacterial respiratory infections are often clinically indistinguishable, yet treatment is different depending on the cause of infection, highlighting the importance of accurate diagnostic tests like Xpert Xpress Flu and Xpert Xpress Flu/RSV. With this development, hospitals and clinics can reliably diagnose influenza and respiratory syncytial virus (RSV) infection in 30 minutes or less.
Xpert Xpress Flu/RSV and Xpert Xpress Flu are twice as fast as their predecessor, Xpert Flu/RSV XC, but have comparable performance characteristics. The new tests feature and share a novel design, which employs multiple targets for each virus. The built-in redundancy results in both high sensitivity and specificity, and reduces the impact of seasonal genomic drift in these viruses that has historically been a problem with molecular tests.
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 www.cepheid.com.
About GeneXpert Systems
With more than 11,000 systems in 182 countries, the GeneXpert System is the world's most popular molecular diagnostics' system. The GeneXpert System's modular configuration means that the system is the most scalable available, offering the ability to perform from one to eighty Xpert tests at the same time. As a result, the GeneXpert System meets the throughput requirements of customers of all sizes - from lower volume point-of-care settings to higher volume reference laboratories – enabling accurate, fast and cost effective test results.
About Xpert and Xpert Xpress Tests
GeneXpert Systems run proprietary Xpert test cartridges. The Xpert test menu spans healthcare-associated infections, sexual health, critical infectious disease, and oncology, and today offers 24 tests outside the US, and 23 tests in the US. The Xpert Xpress tests offer the same quality and accuracy of other Xpert tests, with the added benefit of test results in 30 minutes or less.
More information on the GeneXpert System and the Xpert tests is available on our website at www.cepheid.com.
- Results from negative specimens are reported in approximately 30 minutes. When running in a Flu only or an RSV only reporting mode, positive results can be reported in soon as 20 minutes.
- "Upper Respiratory Tract Infection" Medscape. Menegetti et al; June 2016 (http://emedicine.medscape.com/article/302460-overview)