Roche launches three respiratory test panels on cobas 6800/8800 Systems in CE markets to help identify multiple pathogens with overlapping symptoms in patients

• Acute respiratory infections are one of the leading causes of death and disability globally, presenting substantial health challenges especially for infants, the elderly and the immunocompromised.^1-3
• Three new molecular diagnostic test panels for influenza and other common respiratory illnesses can be run together or alone using one patient sample.
• Flexible syndromic testing tailored to patient needs reduces unnecessary testing and provides clinicians with actionable insights sooner when compared to conventional methods.
• This flexible solution will enable Roche to provide a broad range of respiratory targets with up to three tests out of one sample and can be combined with our COVID-19 offering on cobas® 6800/8800 Systems.
  

Basel, 22 September 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the launch of three molecular PCR diagnostic test panels to simultaneously detect and differentiate common respiratory pathogens: 

• influenza A, influenza B and respiratory syncytial virus (RSV)
• adenovirus (ADV), human metapneumovirus (hMPV) and enterovirus/rhinovirus (EV/RV)
• parainfluenza 1, 2, 3 and 4
  

The three tests can be run together or individually from a single nasopharyngeal swab specimen. As respiratory viruses circulating within a community can vary depending on seasonality and geography, a flexible testing option based on a syndromic-style panel enables personalised healthcare and helps reduce unnecessary testing.

Patients with respiratory infections often have signs and symptoms that are indicative of the disease, but are not specific enough to discern the root cause of the illness. Syndromic testing allows clinicians to test patients simultaneously for multiple pathogens based on overlapping symptoms. By detecting the most common pathogens that cause disease on a flexible set of test panels together, clinicians are provided with actionable insights so the right therapeutic can be prescribed sooner compared to conventional test methods. This in turn enables timely infection control, proper hospital bed management and improved patient care.

“Our latest set of syndromic respiratory solutions allows clinicians to choose the appropriate tests based on the healthcare setting, season and patient needs,” said Thomas Schinecker, CEO Roche Diagnostics. ”By testing only what is medically relevant and necessary, we enable targeted therapy, avoid misuse of antibiotics and reduce unnecessary intervention.”

These new respiratory test panels run on the cobas omni Utility Channel for use with the widely available, high-volume cobas® 6800/8800 Systems, which have proven to bring reliable results quickly to meet the urgent demand for patient testing during the COVID-19 pandemic. Addition of these tests will equip health systems to combat new respiratory diseases when they arise. Roche is looking to expand availability of these tests beyond CE markets in the future.

About respiratory infections
Acute respiratory infections are one of the leading causes of death and disability globally, presenting substantial health challenges especially for infants, the elderly and the immnocompromised.^1-3 Respiratory tract infections include both upper tract infections, like the common cold, and lower tract infections, such as pneumonia, bronchitis and tuberculosis. Respiratory infections are caused by a wide variety of pathogens, like influenza viruses, respiratory syncytial virus, parainfluenza viruses, metapneumovirus, rhinovirus, enterovirus, coronavirus and adenovirus, and other bacteria pathogens.

About the three new Roche tests for Influenza A/B, RSV; ADV, hMPV, EV/RV; and Parainfluenza 1-4
These tests utilise a real-time PCR nucleic acid amplification method to detect specific DNA sequences obtained after extraction or following reverse transcription of RNA. TaqMan® DNA probes that hybridise with the target strand are labeled with a fluorescent dye allowing real-time measurements during the PCR process. Real-time PCR technology allows a rapid and specific measurement of the presence of genes from microorganisms associated with infectious diseases, cancer, and genetic abnormalities.

About the cobas omni Utility Channel on the cobas 6800/8800 Systems
The cobas omni Utility Channel on the cobas 6800/8800 Systems enables a broader testing menu by consolidating open channel assays with Roche in vitro diagnostic (IVD) assays on a single platform. Open channel assays may include IVD assays, as well as routine lab developed tests (LDTs). The ability to consolidate and automate a wider array of testing on a single platform helps to increase operational efficiency, maximise laboratory space and minimise capital investment.

The fully automated cobas 6800/8800 Systems offer the fastest time to results with the highest throughput and the longest walk-away time available among automated molecular platforms. With proven performance, absolute automation and unmatched flexibility delivering unparalleled throughput 24/7—cobas 6800/8800 Systems are designed to ensure a lab’s long-term sustainability and success.
Learn more at cobas68008800.com

About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics, as well as growing capabilities in the area of data-driven medical insights help Roche deliver truly personalised healthcare. Roche is working with partners across the healthcare sector to provide the best care for each person.

Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. In recent years, Roche has invested in genomic profiling and real-world data partnerships and has become an industry-leading partner for medical insights.

Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the twelfth consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).

The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2020 employed more than 100,000 people worldwide. In 2020, Roche invested CHF 12.2 billion in R&D and posted sales of CHF 58.3 billion. 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.

References
[1] World Health Organization. The Global Impact of Respiratory Disease. 2017. www.who.int/gard/publications/The_Global_Impact_of_Respiratory_Disease.pdf Accessed June 4, 2020.
[2] Das S, Dunbar S, Tang YW. Laboratory Diagnosis of Respiratory Tract Infections in Children - the State of the Art. Front Microbiol. 2018;9:2478.
[3] Echavarría M, Marconea DN, Querci M, et al. Clinical impact of rapid molecular detection of respiratory pathogens in patients with acute respiratory infection. J Clin Virol. 2018;108:90-95.

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