FDA-Cleared Multiplex PCR Test Detects 13 Respiratory Pathogens in a Single Sample

Respiratory tract infections can be difficult to distinguish at presentation because many cause overlapping, nonspecific symptoms and are initially grouped as influenza-like illnesses. Causes span a range of viral and bacterial pathogens, while the overall burden remains substantial; in the U.S., influenza viruses alone are estimated to cause 9.3–41 million illnesses annually.

Children, older adults, and immunocompromised individuals face a higher risk of complications, increasing the need for rapid identification of the underlying cause. To aid this differentiation, a newly FDA-cleared multiplex PCR panel now detects 13 respiratory pathogens from a single nasopharyngeal swab to support clinical decision-making

Cepheid’s Xpert Respiratory Panel has received U.S. Food and Drug Administration (FDA) clearance to aid in diagnosing individuals with signs and symptoms of respiratory tract infection when used alongside clinical, epidemiological, and laboratory findings. The assay is intended for situations in which distinguishing among likely respiratory causes can help guide patient assessment.

Using multiplex PCR, the test detects 13 common viral and bacterial respiratory pathogens in a single run from one nasopharyngeal specimen. By identifying multiple potential causes of influenza-like illness at the same time, the panel can help clinicians determine the underlying etiology, inform treatment decisions, and support more appropriate antibiotic use.

The panel runs on existing GeneXpert systems, expanding a respiratory testing portfolio that includes both low- and mid-plex options on the same platform. The workflow remains unchanged, requiring less than one minute of hands-on time and providing on-demand results. The test is expected to begin shipping to U.S. customers in the coming weeks.

Multiplex molecular testing allows simultaneous detection of multiple respiratory pathogens, and rapid multiplex PCR can shorten time to results and support clinical management. This platform approach also lets healthcare organizations match targeted testing or broader syndromic assessment to patient needs. Together, these capabilities can improve patient stratification, workflow efficiency, and resource use.

“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,” said Dr. Connie Savor, Chief Medical Officer at Cepheid.