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Roche Launches the Cobas Pulse System, an Industry First Professional Blood Glucose Management Solution with Mobile Digital Health Capabilities to Improve Patient Care

Basel, 12 January 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the launch of the cobas® pulse system in select countries accepting the CE Mark. The cobas® pulse system marks Roche Diagnostics’ newest generation of connected point of care solutions for professional blood glucose management. As an industry first, the cobas® pulse system combines the form factor of a high-performance blood glucose meter with simple usability and expanded digital capabilities similar to that of a smartphone.

Glucose is among the most important biomarkers to assess patient health and predict, diagnose and manage metabolic disorders¹. In particular, the management of blood glucose in patients is critical to preventing acute and chronic complications that may lead to increased morbidity, mortality and healthcare costs2, 4, 5, 6. Against the backdrop of a rising epidemic of diabetes3 and other non-communicable diseases, the need to regularly perform this critical intervention adds to an ever-growing list of responsibilities facing stretched healthcare systems and professionals.

“Frontline health workers are under increasing pressure to not only accurately diagnose patients, but also make appropriate decisions on all aspects of disease management and patient care,” says Thomas Schinecker, CEO, Roche Diagnostics. “Our commitment is to equip them with high-performance innovations that represent a real step change in their working lives. We are pleased to introduce a truly novel solution that puts actionable clinical insights, and a near limitless range of digital capabilities for patient care, in the palms of their hands.”

Designed for professional use in a range of care settings where timely and informed clinical decisions are needed, the cobas® pulse system introduces several advancements that aim to drastically simplify workflows for busy nurses and doctors and improve their ability to deliver care at the bedside.

For the first time in a point of care device, the cobas® pulse system is equipped with digital health applications based on the Android operating system that perform a range of clinically valuable functions – from clinical decision support to the measurement of vital signs and digital biomarkers. The Roche-selected apps are enabled by a digital platform called Smart, the newest module of the cobas® infinity edge suite of software solutions. The pairing of the cobas® pulse system with cobas® infinity edge smart marks the first integrated solution from Roche Diagnostics to leverage a pioneering business-to-business partnership model that connects developers of digital health solutions with healthcare professionals as customers. At the time of launch, Roche has already secured partnerships with several innovative companies and start-ups in the field (e.g. S4DX, imito, decide (GlucoTab), Glytec, CardioSignal, and SteadySense (SteadyTemp)).

Following first commercial availability under CE Mark in select markets, Roche plans to seek CE IVDR and FDA clearance for the cobas® pulse system in other global markets throughout 2022.

About the cobas® pulse system
The cobas® pulse system is Roche’s newest generation of connected professional blood glucose management solution, building on its legacy with Accu-Chek® Inform II. Designed with advanced safety and performance, simplicity, and enhanced digital power at its core, the cobas® pulse system serves as a gateway to the future of digital health - improving workflows and changing healthcare in favor of cost efficiency and better patient care. The cobas® pulse system is reliable, safe to use in all professional care settings (including intensive care) and with patients of all ages (including neonates). The cobas® pulse system features outstanding performance that meets the criteria of one of the latest guidelines for glucose meters%u2078. It is free from interferences and features an easy-to-clean and robust design equipped for 12,000 cycles of cleaning and disinfection. The cobas® pulse system’s portability and intuitive Android-based interface make using it as simple as a smartphone. Among several other innovations, the cobas® pulse system features an illuminated glucose strip port for ease of use in poorly lit environments, wireless charging, an embedded camera for multiple uses, and secure RFID badging. Cobas® infinity edge smart equips the cobas® pulse system with Roche-selected digital health applications that enable a truly versatile range of operations for patient and workflow management.

About cobas® infinity edge suite of solutions
The Roche software solution suite called cobas® infinity edge includes three modules: unite, scribe, and smart. Used together, the solution facilitates the ability of labs and hospitals to manage patient-testing devices (Roche and non-Roche) that measure clinical health parameters anytime, anywhere. cobas® infinity edge also enables the deployment of third party applications into point of care devices. With this digital ecosystem approach, lab and hospital administrators can also better govern, update and manage use of near-patient testing devices - even remotely. The platform uses industry standard security technologies and processes to connect to electronic medical record systems (EMRs) as well as enabling remote installations, service and maintenance of devices outside the lab/hospital premises (e.g., clinics or pharmacies). This solution will bring more diagnostic capabilities - safely and securely - beyond the lab walls - closer to physicians and nurses at the points where clinical decisions are being made.

About Roche in digital healthcare
With growing investments in digital capabilities, Roche is building on its expertise in science, medicine and technology to increasingly leverage data analytic tools and novel digital technologies to transform the way healthcare is delivered and managed for each patient. Our data-driven digital solutions empower labs, healthcare providers and patients to make informed, insights-based decisions across the entire care continuum – reducing costs to society and improving patient health outcomes in the process.

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, the company 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 thirteenth consecutive year, Roche has been recognised as one of the most sustainable companies in the pharmaceutical 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] Krentz AJ et al. (2016). Biomark Med. 10(11):1153-1166.
[2] Pasquel FJ et al. (2021). Lancet Diab Endocrinol 9: 174–88.
[3] DF DIABETES ATLAS (2019). Ninth edition. https://www.diabetesatlas.org/upload/resources/material/20200302_133351_IDFATLAS9e-final-web.pdf. Accessed September 2021.
[4] ADA Standards of Medical Care in Diabetes. (2021). Diabetes care 44: Suppl 1.
[5] Dhatariya K et al. (2020). NCBI Bookshelf.
[6] Hermanides J et al. (2010). Crit Care Med 38(3): 1430-34.
[7] S4DXImitoGlucoTabGlytecCardioSignal and STEADYTEMP
[8] CLSI POCT12-A3 Point-of-Care Blood Glucose Testing in Acute and Chronic Care Facilities. Clinical and Laboratory Standards Institute, 2013.

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