Roche receives FDA 510(k) clearance for cobas® eplex respiratory pathogen panel 3, enabling labs to customize respiratory testing for local patient needs

INDIANAPOLIS, November 2, 2026 – Roche announced today the U.S. Food and Drug Administration (FDA) 510(k) clearance of the cobas® eplex respiratory pathogen panel 3 (RP3). Designed for the automated cobas® eplex system, this flexible syndromic test offers up to five customizable panel configurations, enabling labs and clinicians to rapidly and accurately identify the cause of respiratory infections to help ensure timely and effective patient care.

During peak respiratory seasons, health systems face immense pressure to accurately differentiate viral and bacterial infections that often have overlapping symptoms. When clinicians have accurate and rapid respiratory results, they can reduce the number of tests and radiographs ordered, decrease unnecessary antibiotic use and decrease the length of time to discharge.

Diagnostic uncertainty creates challenges, particularly for high-risk populations – including the elderly, young children and the immunocompromised – who are at increased risk for severe complications.2 The cobas® eplex RP3 panel addresses these challenges by providing rapid, actionable insights that facilitate efficient patient management and antibiotic stewardship.

Key takeaways

About the cobas® eplex respiratory pathogen panel 3 (RP3)

The cobas® eplex respiratory pathogen panel 3 (RP3) simultaneously detects up to 19 viral and bacterial targets, with broad strain inclusivity, from a single nasopharyngeal swab sample. Like the RP2 panel (EUA),* the RP3 panel detects common pathogens, such as influenza A virus, RSV and SARS-CoV-2, with the addition of Bordetella pertussis, to broaden targeting of bacterial pathogens that can cause severe illness in high-risk patients. The cobas® eplex RP3 panel also has updated assays for influenza virus and SARS-CoV-2 to improve coverage of current and recently circulating strains. It enables laboratories to tailor testing strategies with up to five distinct panel configurations, aligning with local disease prevalence and specific patient population needs.

With an automated "sample-to-answer" workflow process, the test requires less than one minute of hands-on preparation time and supports 24/7 availability. It also delivers highly accurate, qualitative results in less than two hours.

This FDA clearance further expands Roche's respiratory portfolio, which includes a broad range of singleplex and multiplex assays for respiratory viral and bacterial infections, supporting patient testing needs across the continuum of care.

About Roche

Roche (SIX: RO, ROP; OTCQX: RHHBY) is a healthcare company uniquely placed to prevent, stop and cure diseases by uniting leading science and technology across diagnostics, medicines and digital solutions.

Roche was founded in Basel, Switzerland, in 1896 and today is a leading provider of transformative medicines and diagnostics for millions of people in over 150 countries around the world. It is dedicated to tackling healthcare challenges that place the greatest strain on patients, families, communities and healthcare systems. Across its Diagnostics and Pharmaceutical divisions, Roche focuses on areas including oncology, neurology, cardiovascular and metabolic diseases, ophthalmology, infectious diseases, and immunology with the aim of providing real and positive change for patients, the people they love and the professionals who care for them.

Genentech in the United States is a fully owned subsidiary in the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, a major innovator in the Japanese therapeutic antibody market.

For more information, please visit www.roche.com.