Roche Gains FDA Clearance for Flexible Respiratory Pathogen Panel

Respiratory infections often cause overlapping viral and bacterial symptoms, making diagnosis more difficult during peak respiratory seasons. This uncertainty can be especially important for high-risk groups, including older adults, young children, and immunocompromised patients. A newly launched test offers laboratories a flexible panel for rapid respiratory pathogen detection from a single sample.

Roche has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the cobas eplex respiratory pathogen panel 3 (RP3). The test is designed for the automated cobas eplex system and allows up to five customizable panel configurations. This flexibility is intended to help laboratories tailor respiratory testing strategies to local disease prevalence and patient population needs.

The cobas eplex RP3 panel simultaneously detects up to 19 viral and bacterial targets from a single nasopharyngeal swab sample. It includes common pathogens such as influenza A virus, respiratory syncytial virus, and SARS-CoV-2, and adds Bordetella pertussis to broaden bacterial pathogen detection. The panel also includes updated influenza virus and SARS-CoV-2 assays intended to improve coverage of current and recently circulating strains.

The system uses an automated sample-to-answer workflow that requires less than one minute of hands-on preparation time. Results are delivered in less than two hours, and the test supports 24/7 availability. The clearance expands Roche’s respiratory portfolio, which includes singleplex and multiplex assays for respiratory viral and bacterial infections.

The new test expands the existing capabilities of the cobas eplex respiratory pathogen panel 2, which has not been cleared or approved by the FDA. The RP2 test is authorized for use by qualified laboratories under an Emergency Use Authorization. Roche noted that rapid and accurate respiratory results can help clinicians reduce additional tests and radiographs, unnecessary antibiotic use, and time to discharge.

"Timely and accurate respiratory testing in critical situations can guide life-saving interventions," said Dan Malarek, President and CEO, Roche Diagnostics North America. "The cobas eplex RP3 panel gives laboratories the range of testing choices they need with quick turnaround times that can make a difference in patient care."