The FDA has cleared Cepheid's Xpert Respiratory Panel, a multiplex PCR assay that identifies 13 bacterial and viral respiratory pathogens from a single nasopharyngeal swab. The test runs on existing GeneXpert systems, delivers on-demand results, and requires under one minute of hands-on preparation. Intended to be used alongside clinical and epidemiological assessments, the panel aims to speed diagnosis, improve patient management and support antibiotic stewardship. Shipments across the US will begin in the coming weeks.
FDA Clears Cepheid's Xpert Respiratory Panel: Rapid Multiplex PCR for 13 Pathogens
Xpert Respiratory Panel addresses diagnostic challenges associated with acute respiratory conditions. Credit: sasirin pamai/Shutterstock.com.
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Cepheid's Xpert Respiratory Panel, a multiplex polymerase chain reaction (PCR) assay designed to detect 13 common bacterial and viral respiratory pathogens from a single nasopharyngeal swab.
What the Test Does
The panel enables simultaneous detection of multiple respiratory pathogens to help clinicians evaluate patients who present with signs and symptoms of acute respiratory infection — symptoms that frequently overlap with influenza, such as sore throat, cough and fever. The test is intended to be used alongside epidemiological information, laboratory data and clinical assessment to support diagnostic decisions.
Workflow and Performance
The Xpert Respiratory Panel runs on existing GeneXpert systems and complements Cepheid's portfolio of low- and mid-plex respiratory tests. It delivers on-demand results, requires under one minute of hands-on preparation time, and is designed to integrate into established laboratory and clinical workflows to support patient stratification and resource management in hospital settings.
Clinical Impact
Published studies suggest rapid multiplex PCR testing can shorten time to results and improve patient management in hospitals, facilitating faster isolation decisions, targeted therapy and more judicious antibiotic use.
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."
Shipments of the Xpert Respiratory Panel to customers across the US are scheduled to begin in the coming weeks. Earlier this year, Cepheid also received FDA clearance for its Xpert GI Panel, a multiplex PCR solution for gastrointestinal pathogen testing.
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