FDA Grants Clearance of Xpert Xpress Flu, Xpert Xpress Flu/RSV


Diagnostic tests provide accurate results in as little as 20 minutes.

Cepheid received FDA clearance to market its 2 molecular diagnostic tests that will allow hospitals and clinics to accurately diagnose influenza and respiratory syncytial virus (RSV) infection in 30 minutes or less, according to a Cepheidpress release.

Upper respiratory infections are among the most common causes for outpatient visits. Early symptoms of influenza and RSV often present with similar clinical symptoms, making it difficult to differentiate between the 2 infections.

Xpert Xpress Flu and Xpert Xpress Flu/RSV are now twice as fast as their predecessor with comparable performance characteristics to help improve patient care, the company said. The tests feature and share a novel design that employs multiple targets to each virus.

“For too long, clinicians have been asked to treat suspected cases ofinfluenzaempirically, 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, MD, PhD, chief medical and technology officer at Cepheid.

“With the arrival of fast molecular tests like Xpert Xpress Flu and Xpert Xpress Flu/RSV, patients and their health care 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.”

The tests are companies’ first Express branded products, according to the release.

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