Alzheimer’s disease testing

Innovative diagnostics accelerating early detection of Alzheimer’s

In the United States, over 7 million people live with Alzheimer’s disease (AD), and that number is expected to almost double by 2050. In fact, one in three older adults dies with Alzheimer’s or another dementia; AD is the fifth leading cause of death among Americans age 65+. In 2025, Alzheimer’s and other dementias will cost the United States nearly $384 billion. By 2050, this number is projected to be $1 trillion.^1,2,3

An accurate clinical diagnosis of Alzheimer’s is difficult, especially in early disease stages, due to the unspecific symptoms and co-pathologies. This is even more challenging in primary care settings, due to time and resources constraints.⁴

A retrospective study of adults with incident dementia or mild cognitive impairment (MCI) revealed that only 26% of individuals in the incident dementia cohort and 11.4% of individuals in the MCI cohort received a timely diagnosis.⁵

More efficient cognitive assessment tools and AD-specific blood tests can help primary care physicians triage patients with signs, symptoms and concerns of cognitive decline and suspicion of Alzheimer's disease. This allows for early intervention, proactive support for patients and their care partners, and timely referral to specialists for an early diagnosis and disease management.⁴

An early diagnosis empowers physicians and their AD patients to create a personalized care plan and clinical path forward. This includes taking advantage of new therapies and implementing lifestyle changes that may help delay the onset of dementia and/or disease progression.

With decades of intense, targeted research into Alzheimer’s disease, Roche is helping health care providers deliver early, and more accurate diagnoses and patient care.

Roche’s portfolio of Alzheimer’s blood-based biomarker (BBM) and cerebrospinal fluid (CSF) biomarker tests

Clinical validation of Roche’s FDA-cleared biomarker assays demonstrated their correlation with amyloid PET and their likelihood to detect amyloid pathology associated with amyloid plaques. With these tests, it is possible to identify Alzheimer’s disease pathology in individuals with signs, symptoms or complaints of cognitive decline in early disease stages , when new therapies are demonstrated to be most effective.^{9,10,11,12,13}

See For Healthcare Professionals for more information.

Roche’s AD testing portfolio includes one blood test and two CSF ratios:

Elecsys pTau181 plasma¹¹
A blood-based test with a 97.9% negative predictive value as a rule-out for amyloid pathology.

Elecsys pTau181/AB42 CSF ratio⁹
A cerebrospinal fluid test that features 90% concordance with amyloid PET and is therefore able to detect amyloid pathology.

Elecsys tTau/AB42 CSF ratio¹⁰
A cerebrospinal fluid test that also features 90% concordance with amyloid PET and is therefore able to detect amyloid pathology.

Increasing demand, yet limited physician resources

The emergence of new therapeutic interventions have driven increased demand for early diagnosis. However, the limited resources of the primary care providers and specialists affect a timely diagnosis. With the emergence of blood-based testing options, especially in primary care, the reality of beginning the care pathway earlier, is possible. See For Healthcare Professionals for more information about how Roche is playing a leading role in accelerating the path to an earlier diagnosis.