FDA Clears Cepheid’s Rapid Flu Diagnostic Tests

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. 
 
References
¹Results 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. 
²“Upper Respiratory Tract Infection” Medscape. Menegetti et al; June 2016
³http://www.cdc.gov/rsv/research/us-surveillance.html