Sunnyvale, California, United States, November 10, 2026
Cepheid, a Danaher company specializing in molecular diagnostics, has achieved CE marking under the European Union’s In Vitro Diagnostic Medical Devices Regulation (IVDR) for its Xpert® Respiratory Panel, a multiplex polymerase chain reaction (PCR) test designed to detect 13 common viral and bacterial respiratory pathogens from a single nasopharyngeal swab sample. The regulatory milestone strengthens Cepheid’s respiratory diagnostics portfolio and expands testing options for healthcare providers across countries that accept the CE mark. The test is intended to support the diagnosis of suspected infectious respiratory tract infections when interpreted alongside other clinical and laboratory information. By combining multiple pathogen targets in one molecular diagnostic test, the panel is designed to help clinicians distinguish between respiratory infections that can present with similar symptoms. The announcement comes as healthcare systems prepare for seasonal respiratory infections and seek diagnostic solutions that support timely clinical assessment, appropriate treatment decisions and responsible antibiotic use.
One Test Detects 13 Respiratory Pathogens
The Xpert Respiratory Panel is designed to identify 13 respiratory pathogens using a single patient sample. Its detection menu includes Adenovirus, Coronavirus, SARS-CoV-2, Human metapneumovirus, Human rhinovirus/enterovirus, Human parainfluenza, Influenza A, Influenza B, Respiratory syncytial virus (RSV), Bordetella pertussis, Bordetella parapertussis, Mycoplasma pneumoniae and Chlamydia pneumoniae. These pathogens include viruses and bacteria associated with respiratory illnesses, some of which can cause overlapping symptoms such as fever, cough and sore throat. Because clinical symptoms alone may not reliably distinguish the underlying infectious agent, molecular testing can provide additional information to support diagnostic assessment. The panel uses multiplex PCR technology, which enables the simultaneous detection of multiple pathogen targets rather than requiring separate tests for each organism. This approach can help healthcare professionals obtain a broader diagnostic picture from one nasopharyngeal swab. The test is intended as an aid to diagnosis, not as a standalone replacement for clinical evaluation. Results should be considered alongside a patient’s symptoms, medical history and other relevant clinical findings.
IVDR Certification Strengthens European Diagnostics Portfolio
Achieving CE marking under IVDR represents an important regulatory milestone for Cepheid and its respiratory testing portfolio. The European Union’s IVDR establishes requirements for the safety, performance and regulatory oversight of in-vitro diagnostic medical devices. The Xpert Respiratory Panel’s CE marking enables its introduction in countries that accept the CE mark, subject to applicable national requirements and availability. Cepheid stated that shipments to eligible markets are expected to begin in the coming weeks. The regulatory development is particularly relevant for laboratories and healthcare providers seeking diagnostic technologies that meet current European regulatory requirements. Respiratory infections continue to create significant healthcare challenges because different viruses and bacteria can produce similar clinical presentations. Identifying the likely pathogen can help clinicians make more informed decisions about patient management and the need for further testing or treatment. Cepheid’s new IVDR-compliant panel adds another option for healthcare systems looking to strengthen respiratory infection diagnosis and diagnostic stewardship.
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GeneXpert Compatibility Supports Flexible Testing Workflows
The Xpert Respiratory Panel is designed to run on Cepheid’s existing GeneXpert® systems, allowing healthcare facilities using compatible platforms to access the broader respiratory testing menu. The company highlighted that the panel requires less than one minute of hands-on time, supporting a simplified testing workflow and on-demand diagnostic results. Its compatibility with the GeneXpert platform also allows healthcare providers to select from different testing approaches, including targeted single-pathogen tests, mid-plex panels and broader syndromic respiratory panels. This flexibility can help laboratories match testing choices to individual patient needs and local diagnostic strategies. According to Cepheid, multiplex molecular testing can support faster access to pathogen information, while published research has demonstrated that rapid multiplex PCR testing may improve the timeliness of clinical decision-making in hospital settings. Christoph Martinaud, Senior Director of Medical Affairs EMEA at Cepheid, said the new panel further strengthens the company’s respiratory portfolio and gives clinicians more flexibility in selecting appropriate diagnostic options. The development reflects the growing role of molecular diagnostics, automated PCR testing and integrated laboratory platforms in modern infectious disease management. With IVDR CE marking achieved and shipments expected to begin in eligible markets, Cepheid is expanding access to a broader respiratory testing solution for healthcare providers across Europe.
Source: Cepheid press release
