Alzheimer’s disease testing

Advanced biomarker technology for Alzheimer's disease testing and diagnosis offers a brighter future for patients and their loved ones.

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Innovative diagnostics accelerating early detection of Alzheimer’s

Overview

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 the For Healthcare Professionals tab 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 the For Healthcare Professionals tab for more information about how Roche is playing a leading role in accelerating the path to an earlier diagnosis.

For healthcare professionals

Unlocking the power of an early diagnosis and the potential of intervention for more patients

When it comes to Alzheimer’s, an early diagnosis is key to helping patients and their families make informed choices and plan for the future, and enabling clinicians to deliver personalized, patient-centric care.

It is estimated that each day nearly 2,000 patients age 65+ will progress from mild to moderate dementia¹—meaning that a timely diagnosis and therapeutic intervention time are of the essence.

It has been shown that higher intensity lifestyle interventions in individuals at high risk of cognitive decline and dementia had a statistically significant greater benefit on global cognition.¹⁴ Recently approved new therapies demonstrated to be most effective in slowing down cognitive decline and delaying AD progression, when implemented in early disease stages (i.e., MCI and mild dementia).^12,13

Therefore, it is of utmost significance to educate patients on new technologies available for disease detection, possibilities for management and therapies and for healthcare providers to use these recent advances to guide diagnosis and patient management.

Helping address unmet needs in diagnosing Alzheimer’s disease

Elecsys pTau181 plasma¹¹
A blood-based test intended as a rule-out test for amyloid pathology in primary care that features a 97.9% negative predictive value. While a negative test result is consistent with a negative amyloid PET, a positive result indicates that patients should be further investigated to determine whether the amyloid pathology can be a cause of cognitive impairment.

Elecsys pTau181/AB42 CSF ratio⁹
A cerebrospinal fluid test with a 90% concordance with amyloid PET scan that’s intended to assess patients' amyloid pathology status, either as an initial test, or following a triage rule/out test. A positive result is consistent with a positive amyloid PET scan result.

Elecsys tTau/AB42 CSF ratio¹⁰
A cerebrospinal fluid test with a 90% concordance with amyloid PET scan that’s intended to assess patients' amyloid pathology status, either as an initial test, or following a triage rule/out test. A positive result is consistent with a positive amyloid PET scan result.

Roche is blazing new trails in the future of Alzheimer’s testing

Roche’s Elecsys pTau181 Plasma test can help expand integration of primary care practitioners into the Alzheimer’s diagnosis pathway, enabling neurologists and dementia specialists to focus their expertise and resources on patients who may benefit the most from their advanced evaluation and treatment capabilities.

As the only rule-out test indicated for primary care, a negative test result indicates that a patient is not likely to have underlying AD pathology, the Elecsys pTau181 test may help optimize the use of more complex and costly confirmatory tests (e.g., PET scans and CSF testing), reducing the overall diagnostic burden on patients and healthcare systems to potentially shorten the time to diagnosis.

Roche’s Elecsys pTau181 Plasma blood test is designed to aid in the initial assessment for Alzheimer’s disease and other causes of cognitive decline in adult patients aged 55 years and older, presenting with signs, symptoms, or complaints of cognitive decline. The result should be interpreted in conjunction with other clinical information.⁹

NOTE: A positive test result may not be consistent with a positive amyloid PET scan result. Patients with an initial positive result should be further investigated to determine whether the amyloid pathology can be a cause of cognitive impairment.

Roche’s Elecsys pTau217 assay is in development

Roche’s Elecsys pTau217 assay is designed to offer a more comprehensive solution by identifying individuals with high likelihood for a positive, respectively negative amyloid PET scan/CSF result. The assay has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). Learn more

Four reasons to implement Roche’s BBM and CSF tests for Alzheimer’s disease testing

Increasing demand

New AD amyloid targeting therapies require early diagnosis and confirmation of amyloid pathology before initiation,^15,16 reinforcing the value of these AD pathology specific assays for health systems and providers.

Reduces the patient burden for more invasive and costly testing options

By reducing reliance on more expensive testing (i.e., PET and CSF), AD blood tests may help to free up valuable testing resources and clinical expertise for use where they are needed most.

A faster path to diagnosis means help is within reach for more patients

Roche’s pTau181 blood test can be safely administered by a primary care doctor for the exclusion of AD pathology. Its use may therefore improve referral rates and facilitate early, timely diagnosis.

Accuracy

The Elecsys pTau181/Abeta42 and tTau/Abeta42 ratios and the Elecsys pTau181 plasma assay are traceable to reference materials to ensure accuracy of results.

Lab implementation

With 4,500 fully-automated immunoassay analyzers in the US, the AD assays are not only accessible but also scalable, giving patients broad access to high-quality testing in a timely manner.

RUO portfolio

With an emerging menu of Research Use Only (RUO) biomarker assays, Roche is committed to investigating and developing the global solutions that will help researchers find answers in the vast and complex area of neurology.

Roche’s current neurology RUO menu

View full table

01	02	03	04	05	06
AB42* Amyloid beta 42	APOE4* Apolipoprotein E	GFAP* Glial fibrillary acidic protein	NfL* Neurofilament light chain	pTau 217* Phosphorylated Tau 217	YKL40* Chitinase 3-like 1

*For Research Use Only. Not for use in diagnostic procedures.

Additional assays available for research

View full table

Neurology biomarkers
Abeta40**	BD-Tau**
GDF-15**	IGFBP7**
Neurogranin**	NPTX2**
pTau217 (CSF)**	S100b**
SNAP 25**	sTREM-2**
tTau (plasma)**

**The future of neurology includes several assays that are exclusively intended for potential research applications. Please be aware that this information is shared for informational purposes only.

These products are for Research Use Only and not for diagnostic procedures.

For information on how to partner with Roche in furthering your institution’s neurology research efforts, please fill out the form below. A Roche RUO representative will contact you.

Contact Roche

Would you like to know more about how Roche can help with your research efforts?

Please fill out the form to be contacted by a Roche representative in your region.

For people living with AD

Alzheimer’s disease begins to form around 20 years before memory loss or other symptoms develop. However, in the absence of pathology specific biomarkers, AD is not accurately diagnosed in symptomatic individuals, especially if they present with early symptomatic disease. According to the Alzheimer's Association, 85% of people would want to know early if they had the disease.¹⁷

An early and accurate diagnosis is crucial for patients, caregivers and physicians, as it can provide clarity and new treatment options.^18,19

Clinical trials and other studies showed that up to 30% of individuals who meet the criteria for clinical Alzheimer’s dementia based on symptoms did not have Alzheimer’s-related brain changes.¹⁷ By utilizing biomarkers to support Alzheimer’s diagnosis, especially in early disease stages, the accuracy of clinical diagnosis is expected to increase significantly.¹⁹ The need for a more precise diagnosis is now.

Definitions

What are biomarkers?

Biomarkers are biological changes that can be measured to indicate the presence or absence of a disease or the risk of developing a disease. The biomarkers most characteristic to Alzheimer’s are abnormal amyloid beta and tau proteins which accumulate in the brain and are present in the cerebrospinal fluid (CSF) and blood.

Therefore, changes in these proteins can be visualized by imaging the brain with scanning techniques, or can be measured in the CSF and blood^1,2 using laboratory tests.

For example, the Elecsys CSF ratio assays are FDA cleared laboratory tests designed to detect the level of amyloid-beta protein (1-42) (Abeta42), phosphorylated tau protein 181 (pTau181) and total Tau protein (tTau). The results of these tests are intended to be interpreted by the physicians along with other clinical diagnostic evaluations to support AD diagnosis.⁴

Learn more

What is cerebrospinal fluid?

CSF is a fluid that surrounds and protects the brain and spinal cord. CSF contains the abnormal amyloid and tau proteins associated with Alzheimer’s disease (AD). In case of cognitive issues and suspicion of AD, measuring the levels of these proteins from CSF helps with the AD diagnosis process. To collect CSF for testing these specific proteins, a lumbar puncture (spinal tap) is needed.^1,2

Early diagnosis of Alzheimer’s is key

The progression of AD occurs along a continuum, starting with preclinical neuropathological changes, and then progresses to mild cognitive decline that can advance to demetia stages where it interferes with daily life, independence and function. The new amyloid targeting therapies and diagnostic tests have made possible the early detection of amyloid pathology and, in clinical context, early AD diagnosis and referal to therapy. As these therapies are effective in the early disease stages (i.e., MCI and mild dementia), early detection and diagnosis are crucial to timely intervention:^17-20

Mild cognitive impairment due to Alzheimer’s

Mild symptoms but independence is maintained. Diagnosing people at the early, MCI stage, rather than the dementia stage, will allow healthcare professionals to intervene sooner — and at a stage that makes a great difference in people’s lives.

Preclinical AD

Evidence of Alzheimer's pathology, but no symptoms

MCI due to AD

Mild symptoms but independence is maintained

Mild AD dementia

Symptoms interfere with more complex activities and independence is no longer maintained

Moderate to severe AD dementia

Cognitive and functional symptoms interfere with many to most activities and lead to progressive loss of independence

Understanding signs of normal aging vs. Alzheimer’s disease

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Understanding signs of normal aging vs. Alzheimer’s disease

AD affects memory, behavior, problem-solving and daily activities. It’s a medical condition — not part of normal aging — and one of the biggest public health challenges of our time. View the table below to compare normal signs of aging and Alzheimer’s.

Normal aging	Alzheimer's
Occasionally making poor decisions	Frequently making poor decisions and having poor judgment
Occasional errors with managing finances	Trouble keeping track of bills and concentrating
Occasionally needing help with daily tasks	Difficulty completing daily tasks
Getting confused about what day of the week it is, but remembering it later	Confusion about place and time, including losing track of dates and sometimes forgetting where you are and how you got there
Having difficulty finding the right word once in awhile	Struggling with vocabulary, as well as trouble joining or following a conversation
Occasionally misplacing items, but having the ability to retrace steps and find them	Misplacing items, but losing the ability to retrace steps to find them
Lack of interest in social and familial obligations from time to time	Withdrawal from work, hobbies and social obligations
Irritability when a routine is disrupted	Changes in personality and mood, including getting easily upset
Changes with vision, which can be related to cataracts	Difficulty understanding visual images and spatial relationships
Forgetting appointment or names once in a while, but remembering them afterwards	Forgetting recently learned information and asking for the information repeatedly or relying on others for things previously handled on one's own

Alzheimer’s Association. 2024 Alzheimer’s Disease Facts and Figures. Alzheimer's Dement 2024;20(5).

Jeff’s Story: An Alzheimer’s Diagnosis

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Jeff Borghoff was one of them. He finally received a diagnosis after being misdiagnosed with several neurological diseases. He and his wife Kim had pursued an answer for 18 months, and then there it was: Alzheimer’s.