FDA grants Breakthrough Device Designation for Roche's Elecsys cerebrospinal fluid (CSF) assays to support the improved diagnosis of Alzheimer's disease

Basel, 20 July 2018 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today, that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to Elecsys® beta-Amyloid (1-42) CSF and Elecsys® Phospho-Tau (181P) CSF. These in vitro diagnostic immunoassays are for the measurement of the beta-Amyloid (1-42) and Phospho-Tau concentrations in cerebrospinal fluid (CSF) in adult patients with cognitive impairment who are being evaluated for Alzheimer's disease (AD) or other causes of dementia.

Currently, the diagnosis of AD is largely based on clinical symptoms, including cognitive testing, with a significant number of patients diagnosed when their disease has already advanced. A diagnosis of AD based on cognitive measures alone is only correct in 70 - 80 percent of cases. Measuring biomarkers with CSF immunoassays, associated with AD pathology, increases certainty of a diagnosis of AD and can help to evaluate the progression of the disease. The Breakthrough Device Designations are for indication of use with Elecsys beta-Amyloid (1-42) CSF and Elecsys Phospho-Tau (181P) CSF in concordance with amyloid PET visual read result and risk of cognitive or functional decline. The Breakthrough Devices Program is a voluntary program for certain medical devices that provide for more effective treatment or diagnosis of a life-threatening or irreversibly debilitating disease or condition. This program is designed to expedite the development and review of these medical devices.

"We are excited about FDA's recognition of the potential clinical benefit the Elecsys CSF assays can bring to clinicians, laboratories and their patients in diagnosing AD at an early stage," said Roland Diggelmann, CEO of Roche Diagnostics. "Roche was one of the first companies to use biomarkers in clinical trials and we will continue to explore high-performing diagnostic and disease-monitoring solutions."

About Elecsys® CSF immunoassays
Establishing the presence of degenerative diseases of the central nervous system is important when it comes to distinguishing age-related memory disorders from early-stage dementia. Deposits of beta-amyloid peptides (1-42) and neurofibrillary tangles in the brain are the two earliest changes associated with the development of Alzheimer's disease and can be detected by different methods. Biomarkers in the cerebrospinal fluid (CSF) help clinicians detect Alzheimer's disease, the most common form of dementia, from an earlier stage. Currently available for countries accepting the CE Mark*, the Elecsys beta-Amyloid (1-42) CSF, Elecsys Phospho-Tau (181p) CSF and Elecsys(R) Total-Tau CSF immunoassays are in vitro tests for the quantitative determination of concentrations of the beta-amyloid (1-42), phospholylated tau (181P) protein and total Tau protein in human cerebrospinal fluid. ^[1-3] The markers can be used alone or in combination. ^[1-3] The ElectroChemiLuminescence Immunoassay "ECLIA" is intended for use on Elecsys and cobas e immunoassay analyzers. ^[1-3]
*Local product availability may vary independently from CE Mark approval.


About Alzheimer's disease
Alzheimer's disease is a progressive, fatal disease of the brain that gradually destroys memory, thinking skills and problem solving and impairs daily functioning such as the ability to manage one's own activities. Biological changes are believed to start decades before clinical symptoms of Alzheimer's disease become evident. In the early stages (prodromal to mild dementia), people may have difficulty remembering things, but daily function may or may not be impaired. In the later stage of the disease, people increasingly become reliant on others for even simple day-to-day tasks. Dementia affects 44 million people worldwide with 7.7 million new cases each year, of which Alzheimer's disease is the most common form. There is no cure for Alzheimer's disease. Current treatments focus on alleviating symptoms and are unable to stop Alzheimer's from progressing because they do not affect the disease's underlying causes.

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 under one roof have made Roche the leader in personalised healthcare - a strategy that aims to fit the right treatment to each patient in the best way possible.

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.
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. 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. Roche has been recognised as the Group Leader in sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry nine years in a row by the Dow Jones Sustainability Indices (DJSI).

The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2017 employed about 94,000 people worldwide. In 2017, Roche invested CHF 10.4 billion in R&D and posted sales of CHF 53.3 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.

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References
[1] Roche Diagnostics. Elecsys beta-Amyloid (1-42) CSF: Method sheet. 2018. Last accessed: June 2018.
[2] Roche Diagnostics. Elecsys Phospho-Tau CSF: Method sheet. 2018. Last accessed: June 2018.
[3] Roche Diagnostics. Elecsys Total-Tau CSF: Method sheet. 2018. Last accessed: June 2018.

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