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In the news release, Roche launches the cobas eplex respiratory pathogen panel 3, a fast and comprehensive test to help clinicians treat patients with respiratory infections, in CE markets, issued 24-Mar-2026 by Roche over PR Newswire, we are advised by the company that changes have been made. The complete, corrected release follows, with additional details at the end:
Roche launches the cobas eplex respiratory pathogen panel 3, a fast and comprehensive test to help clinicians treat patients with respiratory infections, in CE markets
- The new test detects up to 25 viruses and bacteria, including SARS-CoV-2, influenza, Bordetella pertussis, and RSV, in a single patient sample.
- Rapid results enable doctors to make fast, confident and critical treatment decisions that are vital for high-risk patients.
- Designed for the cobas eplex system, the test is easy to use and available around the clock, helping hospitals manage surges in respiratory cases.
PLEASANTON, Calif., March 24, 2026 /PRNewswire/ -- Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today the launch of the cobas® eplex respiratory pathogen panel 3 (RP3), a new diagnostic test designed to detect a broad spectrum of viruses and bacteria that cause respiratory illness. The test is now available in countries accepting the CE mark.
Differential diagnosis of respiratory infections can be complex because many of the viruses and bacteria associated with respiratory infections may cause very similar symptoms. For vulnerable populations, including the elderly, young children, and those with weakened immune systems, a respiratory infection can quickly become life-threatening.
"In respiratory care, time is everything. Knowing exactly what is making a patient sick allows clinicians to make fast, effective decisions that can save lives," said Josh Lauer, Global Head of Molecular Labs at Roche Diagnostics. "We are providing hospitals with a powerful tool to manage the complexity of respiratory infections, ensuring that patients — especially those at high risk — get the targeted care they need without delay."
The cobas eplex RP3 panel provides critical support to healthcare providers during peak respiratory seasons, which are the most demanding times of the year. The new test detects more than 20 different viral and bacterial pathogens simultaneously. This helps clinicians quickly pinpoint the exact cause of a patient's illness, allowing them to start the right treatment sooner, implement adequate infection and transmission control measures, and, in some cases, avoid unnecessary antibiotic use and improve patient prognosis.
With less than one minute of hands-on time required to start the test, it is incredibly easy for laboratory staff to use. With ease of use and fast time to results, the cobas eplex RP3 panel can help reduce the time patients spend in the emergency room and allows hospitals to better manage isolation beds, keeping infectious patients separate from others.
About the cobas eplex RP3 Panel
The cobas eplex respiratory pathogen panel 3 is a qualitative in vitro diagnostic test aimed at the simultaneous detection and differentiation of up to 25 viral and bacterial targets. It runs on the cobas eplex system, a platform designed to simplify laboratory workflow with features like automated result reporting and external control tracking & monitoring. Like the RP2 panel, the RP3 panel detects common pathogens, such as influenza virus A and B, RSV, SARS-CoV-2,, plus new pathogens including Bordetella parapertussis and Chlamydia pneumoniae that can cause severe illness in high risk patients. The cobas eplex RP3 panel also has updated inclusivity for influenza virus and SARS-CoV-2 to ensure coverage of current and recently circulating strains. This test is also the first in the cobas eplex family to feature flexible syndromic testing, giving the option to labs to customise up to 5 distinct panels based on local prevalence needs or unique patient presentations.
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.
All trademarks used or mentioned in this release are protected by law.
For further information please contact
Yvette Petillon, Group Media Relations
Phone: +41 79 961 92 50
e-Mail: yvette.petillon@roche.com
Brien Mahoney, Molecular Labs Communications
Phone: +1 925 699 8512
e-Mail: brien.mahoney@roche.com
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Correction: The stated number of detectable viruses and bacteria has been corrected from 250 to 25 in the sub-headline.
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- Roche's Ionify® steroid assays join its Vitamin D Total test as the latest mass spectrometry tests to receive CLIA 'moderate complexity' classification.
- The expanded steroid menu brings the sensitivity and specificity of mass spectrometry – the diagnostic gold standard – into routine clinical laboratories.
- The CLIA classification broadens access to advanced testing through a fully automated and standardized workflow on the cobas® i 601 analyzer.
INDIANAPOLIS, March 18, 2026 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has categorized its Ionify® steroid assays for mass spectrometry as "moderate complexity" under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). This designation marks an important step toward expanding access to advanced diagnostic testing, which has historically been limited to highly specialized laboratories due to complex workflows and the need for expert operators.
The Ionify® steroid assays include Estradiol, DHEA, DHEA-S, Progesterone, 17-Hydroxyprogesterone and Androstenedione, which run on Roche's cobas® i 601 analyzer as part of the cobas® Mass Spec solution. By combining the sensitivity and specificity of mass spectrometry with a standardized, easy-to-use workflow, the cobas® Mass Spec solution streamlines complex testing and helps reduce variability across laboratories.
"This technology fundamentally transforms mass spectrometry, moving it from an intricate specialty process to a seamless engine for routine diagnostics," said Brad Moore, President and CEO, Roche Diagnostics North America. "By delivering a broad and expanding mass spectrometry menu with automation and standardization, we are empowering laboratories to operate more efficiently and enabling clinicians to make critical decisions sooner – helping ensure the right treatment reaches the right patient without delay."
The Ionify® steroid assays, together with the previously launched Ionify® 25-Hydroxy Vitamin D total assay, form the growing U.S. portfolio for the cobas® Mass Spec solution with a CLIA "moderate complexity" designation. This classification significantly broadens accessibility, enabling laboratories to routinely offer clinical mass spectrometry assays without the need for specialized operators. Roche remains committed to expanding this menu and maintains an active pipeline of future clinical mass spectrometry assays currently in development and under regulatory review to further extend system and assay availability.
About the cobas® Mass Spec solution
Mass spectrometry is widely regarded as the diagnostic gold standard for a range of clinical applications, including the measurement of steroid hormones in endocrinology and 25-hydroxyvitamin D testing. The cobas® Mass Spec solution combines the high specificity, sensitivity and accuracy of mass spectrometry with a fully automated, integrated, and standardized workflow – making this traditionally complex analytical method accessible to routine laboratories.
In July 2025, the cobas® Mass Spec solution received the "Best New Clinical Diagnostics Instrumentation of 2024" award in the Scientists' Choice Awards® 2025. Established in 2007 by SelectScience, the awards recognize innovations nominated and voted on by the global scientific community.
For more information about cobas® Mass Spec, please visit go.roche.com/ClinicalMassSpec.
About Roche
Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world's largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalized healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.
For over 125 years, sustainability has been an integral part of Roche's business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045.
Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.
For more information, please visit www.roche.com.
All trademarks used or mentioned in this release are protected by law.
For Further Information
Roche Diagnostics U.S. Media Relations
us.mediarelations@roche.com
Amy Lynn
1-317-750-7811
amy.lynn@roche.com
Jen Dial
1-463-867-0232
jen.dial@roche.com
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