The US Food and Drug Administration (FDA) has cleared Roche’s respiratory pathogen testing panel to assist labs and clinicians in identifying the cause of infections as peak respiratory season begins.
The test, dubbed the cobas eplex respiratory pathogen panel 3 (RP3), is designed to rapidly identify the cause of a respiratory infection from a nasopharyngeal swab via the automated cobas explex system – thus allowing clinicians to identify and administer the best care in a shorter space of time.
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By simultaneously detecting up to 19 viral and bacterial targets across strains including respiratory syncytial virus (RSV), influenza and SARS-CoV-2 in less than two hours, cobas explex RP3 is intended to assist healthcare professionals (HCPs) to provide high-risk patients with more effective and potentially life-saving care.
According to Roche, cobas eplex could also help reduce the burden of such diseases on healthcare systems, as accurate diagnostic testing can help to diminish both the number of tests and radiographs ordered and the unnecessary use of antibiotics.
“Timely and accurate respiratory testing in critical situations can guide life-saving interventions,” commented Roche Diagnostics North America’s CEO and president, Dan Malarek.
“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,” Malarek added.
Cobas eplex’s FDA clearance builds on the prior approval of the cobas eplex respiratory pathogen panel 2, which is currently authorised by the FDA for emergency use as a test to detect and identify specific nucleic acids that are present in viral and bacterial strains.
The panel’s FDA clearance marks another positive step forward for the respiratory disease portion of Roche’s diagnostics business, which also houses automated in vitro bacterial DNA-detecting tests such as UC-TIB-Respi-Bac-4 and UC-TIB-NTM and fellow diagnostic test, cobas Influenza A/B & RSV.
IVD market growth continues
Roche secures clearance for cobas eplex RP3 as the wider in vitro diagnostics (IVD) segment experiences strong growth – primarily driven by the continuing emergence of precision medicine and healthcare’s wider priority to diagnose and treat disease earlier.
According to GlobalData’s Medical Device Intelligence Center, Roche is the most prominent player in the IVD space based on 2025 company revenue, with the segment pulling in more than $5bn for the biotech during the year. However, rival Abbott Laboratories is not far behind, having pulled in more than $4.3bn in revenue during 2025.
Currently, analysts at GlobalData forecast that the IVD segment will balloon at a compound annual growth rate (CAGR) of 3.1% to reach $60.6bn in value by 2035.
