Indianapolis, Indiana, USA, November 2, 2026
Roche Diagnostics has announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its new cobas® eplex Respiratory Pathogen Panel 3 (RP3), marking an important advancement in molecular diagnostics and infectious disease testing. Designed for the automated cobas® eplex system, the newly cleared respiratory testing panel enables clinical laboratories to customize diagnostic testing according to local disease prevalence and individual patient needs. The technology can simultaneously detect up to 19 viral and bacterial respiratory pathogens from a single nasopharyngeal swab sample, helping healthcare professionals identify the potential causes of respiratory infections and support timely patient management. The announcement represents another milestone in Roche’s efforts to expand its diagnostic portfolio with advanced molecular testing solutions that address evolving healthcare requirements. The new panel also introduces improved detection coverage for influenza A and SARS-CoV-2 strains, along with the addition of Bordetella pertussis, expanding its ability to identify clinically important respiratory pathogens.
cobas eplex RP3 Expands Respiratory Pathogen Detection Capabilities
The cobas® eplex Respiratory Pathogen Panel 3 has been developed to provide comprehensive respiratory pathogen testing through a single automated diagnostic workflow. The panel simultaneously identifies up to 19 viral and bacterial targets, including commonly circulating respiratory pathogens such as influenza A, respiratory syncytial virus (RSV) and SARS-CoV-2. It also introduces Bordetella pertussis detection, expanding the panel’s bacterial pathogen coverage. This addition is particularly relevant for identifying infections that can cause serious respiratory complications, especially among vulnerable populations. Roche has also updated its influenza virus and SARS-CoV-2 assays to improve inclusivity for current and recently circulating strains. Respiratory infections frequently present with overlapping symptoms, making it challenging for healthcare professionals to distinguish between viral and bacterial causes based on clinical presentation alone. By providing multiple pathogen results from one sample, the new diagnostic panel is designed to support more informed clinical decisions. Rapid identification of respiratory pathogens can also help healthcare facilities improve infection management, support appropriate treatment decisions and strengthen antimicrobial stewardship practices.
Customizable Testing and Faster Laboratory Workflows
One of the major features of the new cobas® eplex RP3 panel is its flexible testing configuration. The system supports up to five distinct panel configurations, allowing laboratories to tailor respiratory testing according to local disease prevalence, healthcare requirements and specific patient populations. This flexibility is enabled by cobas® eplex system software version 3.0 or higher. It can help laboratories optimize testing resources while maintaining access to clinically relevant respiratory pathogen information. Another important feature is its automated sample-to-answer workflow, which reduces the need for extensive manual preparation. According to Roche, the testing process requires less than one minute of hands-on preparation time and delivers qualitative results in under two hours. The system is designed to support continuous availability, including 24-hour laboratory operations. These capabilities may help laboratories manage increased diagnostic demand during seasonal respiratory infection peaks. Faster results can provide clinicians with information to guide patient management, potentially reducing unnecessary additional testing and supporting appropriate use of antibiotics when bacterial infections are identified.
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FDA 510(k) Clearance Strengthens Roche’s Diagnostic Portfolio
The FDA 510(k) clearance represents an important regulatory milestone for Roche Diagnostics North America and further expands the company’s respiratory diagnostics portfolio. The new RP3 panel builds on the company’s existing respiratory testing capabilities and introduces additional flexibility for laboratories using the cobas® eplex platform. According to Dan Malarek, President and CEO of Roche Diagnostics North America, timely and accurate respiratory testing can provide important clinical information during critical healthcare situations. The company also highlighted the importance of rapid diagnostic results for high-risk populations, including young children, older adults and immunocompromised individuals, who may face increased risks of severe complications from respiratory infections. With its expanded pathogen coverage, customizable testing options and streamlined workflow, the cobas® eplex RP3 panel is positioned to support laboratories seeking efficient respiratory diagnostic solutions. The latest FDA clearance highlights Roche’s continued investment in molecular diagnostics and its commitment to developing technologies that support healthcare professionals in identifying infectious diseases and making informed patient-care decisions.
Source: Roche Diagnostics press release
