Roche (USOTC:RHHBY) has received 510(k) clearance from the US Food and Drug Administration (FDA) for its cobas eplex respiratory pathogen panel 3 (RP3), a diagnostic test designed to detect up to 19 respiratory viruses and bacteria from a single patient sample.
The new panel allows laboratories to select from five testing configurations based on local disease prevalence and patient requirements, while delivering results in less than two hours.
The clearance expands Roche’s respiratory diagnostics portfolio and builds on the capabilities of its existing cobas eplex respiratory pathogen panel 2, which operates under Emergency Use Authorisation.
New Diagnostic Panel Expands Respiratory Pathogen Detection
The cobas eplex RP3 panel is designed for use with Roche’s automated cobas eplex diagnostic system and simultaneously identifies multiple respiratory pathogens from a single nasopharyngeal swab.
The test detects common respiratory infections, including influenza A, respiratory syncytial virus (RSV) and SARS-CoV-2.
It also introduces detection of Bordetella pertussis, the bacterium responsible for whooping cough, expanding the panel’s bacterial testing capabilities.
Roche has updated the influenza and SARS-CoV-2 assays to improve detection coverage across current and recently circulating viral strains.
The company said the expanded pathogen coverage is intended to help healthcare professionals distinguish between infections that present with similar symptoms, particularly among vulnerable patients.
Flexible Testing Configurations Designed to Improve Laboratory Efficiency
A key feature of the RP3 panel is its ability to support up to five distinct testing configurations using cobas eplex system software version 3.0 or later.
These configurations allow laboratories to adjust their testing strategies according to regional infection patterns and the needs of specific patient populations.
The automated system requires less than one minute of hands-on preparation and delivers qualitative results within two hours.
Roche said the streamlined workflow supports continuous laboratory operations and could help healthcare providers make treatment decisions more quickly.
Dan Malarek, President and Chief Executive Officer of Roche Diagnostics North America, highlighted the importance of rapid diagnostic testing.
“Timely and accurate respiratory testing in critical situations can guide life-saving interventions,” Malarek said.
He added that the new panel provides laboratories with greater flexibility in selecting appropriate testing approaches while maintaining rapid turnaround times.
Respiratory Testing Supports Clinical Decision-Making
Respiratory infections frequently present with overlapping symptoms, making it difficult to determine whether a patient has a viral or bacterial infection without diagnostic testing.
This challenge becomes particularly important during periods of high respiratory disease activity, when hospitals and laboratories experience increased demand.
Roche said faster identification of infectious agents can support clinical decisions, including the appropriate use of antibiotics and the selection of additional diagnostic procedures.
The company identified older adults, young children and immunocompromised patients as groups that may face greater risks of severe complications from respiratory infections.
The RP3 panel is intended to provide clinicians with additional diagnostic information to support patient management in these settings.
Clearance Strengthens Roche’s Diagnostics Portfolio
The FDA clearance adds another respiratory testing option to Roche’s existing range of molecular diagnostic products.
The company’s respiratory portfolio includes individual pathogen assays and multiplex tests designed to identify several viral or bacterial targets simultaneously.
Roche operates across pharmaceutical and diagnostic markets, with activities spanning oncology, neurology, cardiovascular and metabolic diseases, infectious diseases and immunology.
The new panel forms part of its diagnostics business, which develops laboratory testing systems and assays for healthcare providers.
Outlook
The FDA’s 510(k) clearance enables Roche to introduce the cobas eplex RP3 panel into the US market, expanding the testing options available to laboratories using its existing platform.
The ability to detect up to 19 pathogens, combined with configurable testing panels and automated processing, could support adoption among healthcare providers seeking greater flexibility in respiratory diagnostics.
Roche did not disclose expected sales, pricing or a specific commercial rollout timetable for the new panel.
Future commercial performance will depend on laboratory adoption, respiratory testing demand and the integration of the panel into existing diagnostic workflows.