Roche's Cerebrospinal Fluid (CSF) assays address unmet needs in the detection of amyloid pathology by offering greater accessibility and support for Alzheimer's disease (AD) diagnosis.

• Currently, AD diagnosis is largely based on various cognitive tests, routine laboratory tests and structural imaging (MRI or CT scan), providing accurate diagnosis in only 70-80% of cases.¹
• Available across Canada, Roche's assays can measure three biomarkers: the Beta-amyloid and tau proteins. These play a role in normal brain function; abnormal levels of these proteins are directly related to Alzheimer's disease.
• In AD, measuring changes in biomarkers can help medical teams understand how quickly a patient's condition may be advancing, and potentially, predict how it may develop in the future.
• Earlier and more accurate diagnoses allow patients to be aware of their AD progress and to adopt appropriate lifestyle changes while preparing for the future.

LAVAL, QC, June 8, 2023 /CNW/ - Roche Diagnostics, a division of Hoffmann-La Roche Limited, is proud to announce Health Canada approval for its Cerebrospinal Fluid (CSF) assays* to measure three biomarkers that are hallmarks of Alzheimer's pathology, beta-amyloid and tau proteins, in adults aged 55 and older being evaluated for the disease.

"The diagnosis of Alzheimer's disease takes time and while this has improved in recent years, many patients are still not diagnosed until their condition has progressed to a late stage," said Michele D'Elia, Executive Director Medical and Scientific Affairs at Roche Diagnostics. "Timely AD diagnosis is a huge unmet medical need. Since cognitive decline may be misinterpreted as a normal characteristic of aging, early diagnosis through biomarkers would help facilitate the identification of patients facing cognitive decline as a result of AD."

AD Diagnosis landscape

Currently there are different types of brain scans - including CT and MRI scans - but clinical criteria for these types of testing are limited and lead to an accurate diagnosis in only 70-80% of cases. To increase diagnostic accuracy, an amyloid positron emission tomography (PET) scan - allowing a specialist to look at the brain to see if beta-amyloid plaques or tau tangles have formed - can be used as an adjunct to these evaluations.² However, the high cost, limited availability and time-consuming nature of such tests, as well as concerns with radioactivity exposure, limit their use.

Roche's assays achieve 90% concordance with the Amyloid PET scan imaging³ and have the potential to provide a more affordable and accessible option for routine testing to confirm the presence of amyloid in the brain. They also offer detection of multiple biomarkers from one lumbar puncture draw, with no radiation, and offer greatly improved potential to detect Alzheimer's pathology in the disease's early stages.⁴ For more information about AD diagnosis, click here.

Patients and caregivers empowered

According to the Dementia in Canada - Cross-Country Report 2022 published by CanAge - an advocacy group whose mission is to advance the rights and wellbeing of aging Canadians - dementia is a global challenge of truly epic proportions and early diagnosis and intervention is key for those living with dementia as early diagnosis provides several key benefits in treatment and care options.⁵

The Alzheimer Society of Canada also highlights the importance of dementia diagnosed early as it helps both the person and family members to learn about the disease, set realistic expectations and plan for their future together. Some of these benefits are: Knowing what to expect, becoming more actively involved in personal decisions, including healthcare; using treatments more effectively; making empowered choices, taking advantage of resources, and helping reduce stigma.⁶

"Through early diagnosis, we are able to give patients a greater opportunity to prepare for the future. Being better aware of your status and knowing your cognitive disease state can help those with AD make appropriate lifestyle changes, including improved sleep, a healthier diet and exercise," said Laura Tamblyn Watts, President & CEO, CanAge, Canada's national seniors' advocacy organization. "Early diagnosis is empowerment. It helps with decision-making, opens the door to more informed support and may help advance research."

The Role of Biomarkers

Biomarkers are measurable indicators of what's happening in the body, and can be found in blood, other body fluids, organs and tissue. They are key to helping doctors and researchers track healthy processes, diagnose diseases and other health conditions, monitor responses to medication and identify potential health risks. In AD, measuring changes in biomarkers can help medical teams understand how quickly a patient's condition may be advancing, and potentially, predict how it may develop in the future. AD Biomarkers help researchers detect early brain changes, better understand the impact of various risk factors, identify participants who meet particular requirements for clinical trials and studies, and track participants' responses to therapies or other interventions, such as physical exercise.⁷

"While biomarker changes may be detectable 10-20 years prior to memory loss and subtle behavior changes of mild cognitive impairment, the biggest challenge is to accurately diagnose Alzheimer's disease as quickly as these changes are noticeable," said Dr. Sandra Black, cognitive neurologist and Senior Scientist and Scientific Director of The Dr. Sandra Black Centre for Brain Resilience & Recovery at Sunnybrook Research Institute "Mild cognitive impairment can be assessed via cognitive testing and daily function questionnaires, but until recently, more precise diagnostic testing was only made available via research protocols. These tests lacked the precision and automation needed for full scale implementation in clinical routine laboratories. This is no longer the case, and we look forward to helping clinicians and laboratories across the country gain access to Roche's technology."

Increasing numbers of AD in Canada

In 2020, it was estimated that there were 597,300 individuals living with dementia in Canada. By 2030, this number is expected to reach close to 1 million, with nearly 187,000 new cases being diagnosed each year. The anticipated increase in the incidence of dementia means that by 2030 there would be a 51% increase in the number of new cases per year and an overall increase of 65% in the number of Canadians living with dementia. Alzheimer's dementia will continue to be the dominant type of dementia in Canada in the coming decades, with over 1.1 million people affected by 2050. Altogether, by 2050, the number of people living with dementia will almost triple from 2020 levels, with over 1.7 million Canadians living with dementia.⁸

"Canada's aging population, combined with the overloaded schedules of many physicians, can become the 'perfect storm' for patients who present symptoms of dementia and who need to rely on healthcare professionals to provide the right care, at the right time," said Dr. Sandra Black "Healthcare professionals need to be equipped with state-of-the-art technology that will help them provide patients with improved access to accurate diagnostic solutions, ideally during the earliest stages of the disease and without excessive delay, so that treatment options can be explored earlier."

About Alzheimer's Disease and Dementia

Alzheimer's disease (AD) is a progressive, neurodegenerative disease associated with cognitive function and behavioral impairments.^₉ It represents the most common type of dementia.10 Dementia is the overall term for conditions and diseases characterized by loss of cognitive functioning such as memory, language skills, visual perception, problem solving, self-management, and the ability to focus and pay attention.¹¹

*About Roche's Elecsys® Alzheimer's disease (AD) CSF assays

Approved by Health Canada last April 14th, 2023, Roche's AD CSF assays (the Elecsys® beta-Amyloid (1-42) CSF II (Abeta42), Elecsys® Phospho-Tau(181P) CSF (pTau181) and Elecsys Total-Tau CSF can be performed on the cobas© fully automated immunoassay analyzers. These analysers are available all across Canada, meaning that patients will now get broader access to high quality AD biomarker testing.

How does it work?

Alzheimer's disease is characterized by the abnormal accumulation in the brain of amyloid beta and tau proteins, which are biomarkers of Alzheimer's hallmark pathology. Roche's Elecsys® Alzheimer's disease (AD) CSF assays accurately and reliably measure the beta- Amyloid (1- 42), Phospho- Tau (181P) and Total-Tau protein concentrations in CSF in adult subjects, ages 55 and older, being evaluated for Alzheimer's disease and other causes of cognitive impairment to generate a pTau181/Abeta42 ratio value and T-Tau/Abeta42 ratio value. As changes in these biomarkers levels occur at early stages of the disease, the assay can detect Alzheimer's pathology in earlier stages of disease (e.g. mild cognitive impairment).

For more information on Roche Elecsys biomarkers in Alzheimer's disease, please visit Roche Global website.

About Roche in Alzheimer's disease

With more than two decades of scientific research in Alzheimer's, Roche is working towards a day when we can detect the disease early and stop its progression to preserve what makes people who they are.

Today, the company's Alzheimer's portfolio spans investigational medicines for different targets, types and stages of the disease. Roche continues to expand its large portfolio of diagnostic solutions with the introduction of Cerebrospinal fluid (CSF) based Alzheimer's disease testing and developing a strong pipeline of biomarkers for neurological conditions.

Yet the global challenges of Alzheimer's go well beyond the capabilities of science, and making a meaningful impact requires collaboration both within the Alzheimer's community and outside of healthcare. We will continue to work together with numerous partners with the hope we can transform millions of lives.

* Elecsys® β-Amyloid (1-42) CSF II assay, Elecsys® Phospho-Tau (181P) CSF assay and Elecsys Total-Tau assay are registered trademarks.