Sunnyvale, California, U.S., September 29, 2026

Cepheid, a Danaher company specializing in molecular diagnostics, has received U.S. FDA clearance for the Xpert® Respiratory Panel, a multiplex PCR test designed to aid in the diagnosis of respiratory tract infections. The newly cleared in vitro diagnostic (IVD) medical device can simultaneously detect 13 common viral and bacterial respiratory pathogens from a single nasopharyngeal swab sample, providing healthcare professionals with broader molecular testing capabilities through Cepheid’s established GeneXpert® platform. The clearance expands Cepheid’s respiratory diagnostic portfolio and is intended to support clinical assessment of patients presenting with signs and symptoms of respiratory tract infection.

Xpert Respiratory Panel Detects 13 Pathogens

Respiratory tract infections can be challenging to diagnose because viral and bacterial infections frequently produce overlapping symptoms, including fever, cough and sore throat. The Xpert Respiratory Panel addresses this diagnostic challenge by using multiplex molecular testing, allowing multiple pathogen targets to be assessed from a single patient specimen. According to Cepheid, the FDA-cleared panel detects 13 common respiratory pathogens, giving clinicians additional laboratory information that can be considered alongside clinical, epidemiological and other laboratory findings when evaluating patients with suspected respiratory infection. The ability to identify multiple potential causes from one sample is particularly relevant when respiratory symptoms do not clearly indicate whether an infection is viral or bacterial. Cepheid said the test is designed to support diagnostic stewardship, helping healthcare organizations select appropriate testing strategies and potentially supporting more informed treatment decisions and responsible antibiotic use. The company’s respiratory testing portfolio ranges from targeted pathogen testing to broader syndromic molecular assessment on the GeneXpert platform.

Multiplex PCR Supports Faster Respiratory Testing

The Xpert Respiratory Panel is designed to run on existing GeneXpert systems, allowing healthcare organizations already using the platform to incorporate the new respiratory panel into their molecular diagnostic workflows. Cepheid states that the test requires less than one minute of hands-on time, while providing on-demand molecular diagnostic results. This workflow is intended to simplify testing while supporting healthcare providers managing patients with suspected respiratory infections. Multiplex PCR technology can simultaneously examine multiple pathogen targets, potentially reducing the need for sequential testing when several infectious agents could explain a patient’s symptoms. Cepheid highlighted the role of comprehensive respiratory testing in supporting patient stratification, workflow efficiency and healthcare resource utilization. The company also cited published evidence indicating that rapid multiplex PCR testing can reduce time to results and may support clinical management in hospital settings.

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Cepheid Expands GeneXpert Respiratory Portfolio

The FDA clearance further strengthens Cepheid’s molecular diagnostics portfolio, which covers respiratory infections as well as blood virology, women’s and sexual health, tuberculosis, healthcare-associated infections, oncology and human genetics. The Xpert Respiratory Panel complements the company’s existing respiratory testing options and gives laboratories and healthcare providers another testing approach on the GeneXpert platform.

Cepheid Chief Medical Officer Dr. Connie Savor said the panel was designed to support high-acuity respiratory testing by focusing on specific pathogen targets that can provide information for timely clinical decisions. The company announced that the Xpert Respiratory Panel is expected to begin shipping to U.S. customers in the coming weeks. The product is designated as a US-IVD medical device, making the FDA clearance a significant regulatory development in the molecular diagnostics and clinical testing sector.

Source: Cepheid press release