The assay identifies viral and bacterial targets from a nasopharyngeal swab to aid diagnosis and diagnostic stewardship.
The US Food and Drug Administration has cleared Cepheid’s Xpert Respiratory Panel, a multiplex PCR test designed to detect 13 common viral and bacterial respiratory pathogens from a single nasopharyngeal swab sample.
The molecular assay is intended to aid in the diagnosis of individuals suspected of having respiratory tract infections who display clinical signs and symptoms, when evaluated in conjunction with other clinical, epidemiological, and laboratory findings. Cepheid, a Danaher company, announced that the test will begin shipping to US customers in the coming weeks.
Addressing Diagnostic Challenges and Overlapping Symptoms
Common acute respiratory tract infections frequently present as influenza-like illnesses characterized by nonspecific symptoms such as cough, fever, and sore throat. Because these presentations can stem from diverse bacterial and viral agents, clinical assessment based solely on presentation remains difficult. The public health burden remains significant, with influenza viruses alone causing an estimated 9.3 million to 41 million illnesses each year in the US.
Certain patient demographics—including pediatric populations, older adults, and immunocompromised individuals—face higher risks of adverse outcomes and hospitalization from respiratory illness. Furthermore, distinct viral infections and co-occurring bacterial infections have been linked to increased disease severity, highlighting the role of laboratory identification in guiding clinical intervention.
By detecting both viral and bacterial pathogens, the panel aims to assist clinicians in selecting targeted treatments and practicing responsible antibiotic use.
“The Xpert Respiratory Panel is designed to support high-acuity respiratory testing,” says Dr Connie Savor, chief medical officer at Cepheid, in a release. “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 panel runs on existing GeneXpert systems, expanding Cepheid’s menu of low- and mid-plex respiratory options. For clinical laboratories, the test retains standard operational protocols, requiring less than one minute of hands-on preparation time while delivering on-demand results to support clinical management and patient stratification.
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