The US Food and Drug Administration (FDA) has granted clearance to Cepheid for its Xpert Respiratory Panel, a multiplex polymerase chain reaction (PCR) diagnostic test.
The panel is designed to identify 13 common bacterial and viral respiratory pathogens from one nasopharyngeal swab.`
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It is intended to help in evaluating patients suspected of having respiratory tract infections who display clinical signs and symptoms.
Intended for use alongside other epidemiological, laboratory, and clinical assessments, the test addresses diagnostic challenges associated with acute respiratory conditions.
These illnesses often present as influenza-like conditions with non-specific, overlapping symptoms such as sore throat, cough, and fever.
By allowing the simultaneous detection of multiple pathogens, the panel is designed to support clinical treatment decisions and encourage responsible use of antibiotics.
Evidence from published studies indicates that rapid multiplex PCR testing can decrease time to results and aid patient management within hospital environments.
Cepheid chief medical officer Dr Connie Savor said: “The Xpert Respiratory Panel is designed to support high-acuity respiratory testing. It helps clinicians make informed decisions by focusing on specific pathogen targets that can support timely care.
“This clearance reflects our commitment to continuously accelerate ideas to impact, bringing meaningful diagnostic innovations to providers and patients.”
The newly cleared panel operates on existing GeneXpert systems, adding to Cepheid’s existing low- and mid-plex respiratory options.
This test provides on-demand results and requires under one minute of hands-on preparation time, fitting into established workflows while supporting patient stratification and healthcare resource management.
Shipments of the Xpert Respiratory Panel to customers across the US are scheduled to begin in the coming weeks.
Earlier this year, Cepheid received clearance from the FDA for its Xpert GI Panel, a multiplex polymerase chain reaction (PCR) gastrointestinal (GI) pathogen testing solution.
