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Cepheid received FDA 510(k) clearance for the Xpert Respiratory Panel, a multiplex PCR test that detects 13 common viral and bacterial respiratory pathogens from a single nasopharyngeal swab. The test is indicated to aid in the diagnosis of respiratory tract infection when used with other clinical and laboratory findings. It will begin shipping to U.S. customers in the coming weeks and runs on existing GeneXpert systems.
Cepheid Receives FDA Clearance for Xpert® Respiratory Panel to Aid in the Diagnosis of Respiratory Tract Infection Cepheid Receives FDA Clearance for Xpert® Respiratory Panel to Aid in the Diagnosis of Respiratory Tract Infection News provided by Cepheid Sep 29, 2026, 09:00 ET Share this article Share to X Share this article Share to X FDA-cleared PCR test detects 13 common respiratory pathogens from a single sample SUNNYVALE, Calif. , Sept. 29, 2026 /PRNewswire/ -- Cepheid, a Danaher company, announced today that it has received FDA clearance for the Xpert Respiratory Panel, a multiplex PCR test designed to detect 13 common viral and bacterial respiratory pathogens from a single nasopharyngeal swab sample. The test is intended to aid in the diagnosis of individuals suspected of having respiratory tract infection with clinical signs and symptoms of respiratory tract infection, in conjunction with other clinical, epidemiological, and laboratory findings. Continue Reading Xpert Respiratory Panel image. Respiratory Infections Pose Diagnostic Challenges Common acute respiratory tract infections are often categorized as influenza-like illnesses (ILI) because they present with overlapping, nonspecific symptoms such as fever, cough, and sore throat. 1 These illnesses may be caused by a range of viral and bacterial pathogens, complicating clinical assessment.² The public health burden is substantial; influenza viruses alone are estimated to cause between 9.3 and 41 millio