Roche receives MDR certification for its science-based smartphone app Floodlight MS

- Floodlight MS complies with the new EU Medical Device Regulation (MDR), reinforcing confident use by patients and their healthcare providers

- MDR certification provided by an independent notified body confirms Floodlight MS meets high standards of quality and safety for market access in the EU

- Ensuring compliance with the new MDR further proves Roche's ability to develop clinically relevant digital solutions, strengthening its position as a trusted partner in digital healthcare

BASEL, Switzerland, Jan. 12, 2022 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that Floodlight™ MS, a smartphone app that enables data-driven clinical conversation and healthcare provider decision-making on a patient's multiple sclerosis (MS), has achieved MDR certification. MDR certification is required to commercialise medical devices in the European Union.

"For people living with MS and their healthcare providers, this certification reinforces the safety, efficacy and performance of Floodlight MS and further supports their confidence in using the app to help guide personalised care decisions," said Moritz Hartmann, Global Head of Roche Information Solutions of the company's Diagnostics Division. "The certification is representative of Roche's commitment to Digital Healthcare, backed by clinical data and supported by clinical evaluation, quality management systems and risk management procedures."

MDR certification requires significant organisational process and rigor, the creation and maintenance of a quality management system and risk management procedures, and the demonstration of clinical validation and usability of medical devices. The certification also assesses cybersecurity measures for a product and demonstrates compliance with data security requirements. The Floodlight MS solution is compliant with ISO27001, the international standard for information security for cloud-based products and with GDPR and HIPAA data privacy regulations. Getting Floodlight MS MDR certified highlights that Roche has these capabilities and that they meet or exceed the stringent review by independent notified bodies.

Being able to bring MDR certified software as a medical device to market enables Roche to deliver clinically-relevant digital solutions that have the potential to meaningfully support patient care and outcomes in a timely manner.

Measuring MS

An estimated 2.8 million people^[1] around the world are living with MS. Although rarely fatal, people living with this neurological condition often experience a variety of life-changing symptoms^[2].

The main goal of a healthcare provider involved in treating a person with MS is to manage disease activity and reduce the risk of disability worsening. A critical factor for achieving this goal is the ability to assess MS symptoms and function to understand more about a patient's disease.

The way we measure the impact of MS on daily life is heavily reliant on in-person clinic visits that may only occur once or twice each year. Often, these visits are based on subjective and incomplete information as examinations are only a snapshot of a patient's disease state. This paradigm fails to capture the subtle mental and physical changes, possibly reflecting MS disease worsening, that can occur between visits. > Hear a patient and a neurologist reflecting on current disease measurement standards.

Floodlight MS can help to bridge this gap: With daily information gathered from patients, the app can provide a more holistic picture of an individual's disease state to support treatment decisions.

About Floodlight MS

Floodlight MS is a science-based smartphone app that enables data-driven clinical conversations and healthcare provider decisions by providing assessments that can be used to collect objective data on patient function in-between clinical visits. The assessments measure gait and dynamic balance, hand function, and cognitive function. The app also provides questions that enable users to journal MS symptoms, mood, and physical status.  This data in combination with the in-person physician visits provide a more complete picture that allows better and more accurate healthcare decisions. > Watch this video to learn more about Floodlight.

Floodlight MS is available in select healthcare clinics or through app partners in selected markets. These include the United States, Germany, Finland, and Portugal, and availability will expand across additional markets in 2022. It is accessible as a standalone application and also offers options to enable interoperability with third party solutions.

Roche Diagnostics in digital health

With growing investments in digital capabilities, Roche is increasingly leveraging data and novel technologies to transform the way care is delivered and managed for each patient. Our data-driven digital solutions empower lab leaders, 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] Multiple Sclerosis International Federation. Atlas of MS [internet, cited January 2022]. Available from: https://www.atlasofms.org
[2] NHS. Health A to Z:  Multiple sclerosis, symptoms [internet, cited January 2022]. Available from: https://www.nhs.uk/conditions/multiple-sclerosis/symptoms

For further information

Karin Erbacher
Head of Communications Roche Information Solutions, Diagnostics
karin.erbacher@roche.com
+41 79 561 0367

Video - https://www.youtube.com/watch?v=k8XulS3IxBc
Video - https://mma.prnewswire.com/media/1724325/Floodlight_Overview_Video.mp4