One trusted laboratory to untangle overlapping symptoms
Simplified dementia testing on a complicated journey
As medical research continues to validate the utility of fluid biomarkers to detect brain changes associated with Alzheimer’s disease and related dementias, the number of blood and cerebrospinal fluid biomarker tests has ballooned. Identifying the best test for risk stratification, diagnosis, and prognosis when faced with overlapping symptoms can be a challenge.
Mayo Clinic Laboratories reduces the guesswork of choosing the right test by offering a full portfolio of cutting-edge fluid biomarker testing for Alzheimer’s disease and related dementias. Developed by clinical and testing experts with decades of experience diagnosing and treating dementia, our industry-leading assays provide accurate answers to guide diagnosis and care at every point in a patient’s journey with dementia.
From specimen to interpretation: expertise you can trust
Objective biomarker testing helps confirm what’s driving cognitive decline — so patients can receive the right care sooner. Mayo Clinic Laboratories, in collaboration with our strategic partners, offers a sophisticated menu of blood and CSF biomarker testing for a wide array of conditions, including Alzheimer’s disease and Alzheimer’s disease with mixed pathology, Parkinson’s disease dementia, autoimmune dementia, rapidly progressive dementia, including Creutzfeldt-Jakob disease, hereditary dementia, and more. Our integration with Mayo Clinic and focus on improving patient outcomes support the development of innovative, clinically meaningful testing.
“When you look at how the field has evolved and now that we have disease-modifying therapies available, biomarker testing — good biomarker testing for Alzheimer's disease — will become an essential component of the clinical evaluations of patients with cognitive impairment.”
Alicia Algeciras-Schimnich, Ph.D., professor of laboratory medicine and pathology at Mayo Clinic
Alzheimer’s disease blood testing
Our innovative plasma biomarker testing to detect Alzheimer's disease pathology includes both Mayo Clinic Laboratories-developed testing and Precivity testing from C2N Diagnostics. These noninvasive tests are recommended for patients 50 and older who present with symptoms of mild cognitive impairment or dementia.
- Mayo Clinic Laboratories’ phosphorylated Tau 217 test (Mayo ID: PT217) evaluates for phosphorylated Tau 217 (p-Tau217) and uses a two-cutpoint model of result interpretation, which maximizes the overall testing accuracy.
- Test interpretation cutpoints have been optimized to obtain an overall 92% sensitivity and 96% specificity for the detection of abnormal amyloid pathology based on amyloid-PET positivity. This test achieves 93% overall accuracy based on a 64% prevalence of amyloid positivity.
- We offer multiple Precivity tests from C2N Diagnostics, including PrecivityAD2 and Precivity AD2 with reflex to apolipoprotein E (ApoE).
- PrecivityAD2™ (Mayo ID: C2AD2) measures Aβ42, Aβ40, p-Tau217, and non-phosphorylated Tau 217 (np-Tau217) and then combines two ratios — Aβ42/40 and %p-Tau217 (p-Tau217/np-Tau217) — into a clinically and analytically validated algorithm to generate the Amyloid Probability Score 2 (APS2).
- PrecivityAD2 with reflex to ApoE (Mayo ID: AD2AR) is identical to C2AD2 but with a reflex to ApoE.
- These assays use a single APS2 cutpoint optimized to obtain an overall 88% sensitivity and 89% specificity. At observed disease prevalence of 53%, the test achieves 88% overall accuracy, 90% positive predictive value (PPV), and 87% negative predictive value (NPV).
Alzheimer’s disease cerebrospinal fluid (CSF) testing
We offer two CSF tests. Results of these assays are based on ratios of p-Tau181 and Aβ42 (Mayo ID: ADEVL) and Aβ42 and Aβ40 (Mayo ID: AMYR), which allow for greater than 90% diagnostic accuracy compared to standard assessments.
Alzheimer’s disease with mixed pathology and dementia with Lewy bodies testing
We offer the SAAmplify™–αSYN to assist with diagnosing synucleinopathies, such as dementia with Lewy bodies (DLB) and Alzheimer’s disease with Lewy body (AD-LB) pathology. This unique seed amplification assay identifies misfolded α-synuclein in CSF. Designed for individuals with clinically uncertain neurodegeneration, results can help diagnose patients with DLB and AD-LB even before the appearance of definitive symptoms.
Autoimmune dementia testing
Our autoimmune dementia testing (Mayo IDs: DMC2 and DMS2) uses a reflexive, algorithmic approach and multiple methodologies, including indirect immunofluorescence assay (IFA), cell-binding assay, immunoblot, radioimmunoassay, and Western blot to detect for nearly 20 neural antibodies associated with autoimmune dementia.
Hereditary Alzheimer’s disease and dementia testing
We offer a number of genetic assays to identify gene variations associated with hereditary Alzheimer’s disease and dementia. Among our genetic offerings are genotyping of APOE (Mayo ID: APOEG), which can help assess susceptibility for Alzheimer’s disease, and NOTCH3 (Mayo ID: NTC3Z), which is associated with cerebral autosomal dominant arteriopathy with subcortical infarcts and leukoencephalopathy (CADASIL). Our genetic testing is developed and supported by an integrated team of clinical, genetic, and laboratory experts and uses precision technologies to reveal variations related to diagnosis and treatment.
Rapidly progressive dementia testing
Our first-in-class rapidly progressive panel (Mayo ID: RPDE) combines traditional Alzheimer’s disease biomarker testing with a real-time quaking-induced conversion (RT-QuIC) assay that detects prion disease with high diagnostic accuracy, and a clinically validated t-Tau to p-Tau ratio that outperforms other non-disease-specific neurodegenerative markers.
Glial fibrillary acidic protein testing
Glial fibrillary acidic protein (GFAP) is an astrocyte-specific protein released into biofluids during astrocyte activation resulting from trauma, neurodegenerative conditions, neuroinflammation, and other factors. Used in combination with other first-line plasma tests for Alzheimer’s disease, results from our GFAP test (Mayo ID: GFAPP) may aid with differential diagnosis to establish the correct cause of neurodegeneration as well as to better understand disease progression.
Neurofilament light chain testing
We offer neurofilament light chain (NfL) testing (Mayo ID: NFLP), which is a nonspecific biomarker for several neurodegenerative disease processes, including Alzheimer’s disease.
One-stop laboratory solution
In cases where blood-based biomarker testing does not yield definitive answers, Mayo Clinic Laboratories offers a comprehensive menu of dementia testing.
| Alzheimer's disease | Prion disease | Autoimmune dementia | Genetic testing | Nonspecific | Synucleinopathies |
|---|---|---|---|---|---|
| Plasma biomarker testing | Rapidly progressive dementia | Autoimmune and paraneoplastic antibody testing | Apolipoprotein E (ApoE) genotyping | Neurofilament light chain | Cerebrospinal fluid biomarker testing for alpha-synuclein pathology |
| Cerebrospinal fluid biomarker testing | Creutzfeldt-Jakob disease | NOTCH3 full- gene analysis | Glial fibrillary acidic protein | ||
| Inherited frontotemporal dementia and amyotrophic lateral sclerosis | |||||
| Early-onset familial testing |
Highlights
This presentation offers a clear introduction to emerging blood based biomarkers for Alzheimer’s disease.
In this video, Dr. Vijay Ramanan shares perspectives on rational approaches to testing in the cognitive neurology, mild cognitive impairment, and dementia settings.
SAAmplify™-αSYN testing offers unprecedented accuracy in diagnosing Parkinson’s and Lewy body dementia.
Join us for a webinar exploring the revolutionary way SAAmplify™–αSYN testing, which is offered by Mayo Clinic Laboratories in collaboration with Amprion, is improving diagnostic accuracy for patients with neurodegenerative disorders.
Diagnostic advances allow earlier & more accurate detection of Alzheimer's using cerebrospinal fluid biomarkers.
In this episode of “Answers From the Lab,” host Bobbi Pritt, M.D., chair of the Division of Clinical Microbiology at Mayo Clinic, and William Morice II, M.D., Ph.D., CEO and president of Mayo Clinic Laboratories, discuss recent news about the use of artificial intelligence (AI) tools in healthcare.
For healthcare professionals seeking to enhance their understanding of the assessment and treatment options for patients with neurodegenerative diseases.
In this episode of “Answers From the Lab,” William Morice II, M.D., Ph.D., CEO and president of Mayo Clinic Laboratories, is joined by Russ Lebovitz, M.D., Ph.D., CEO and co-founder of Amprion. They discuss their strategic collaboration and the innovative SAAmplify™–αSYN (CSF) test.
Mayo Clinic Laboratories and Amprion, a global leader advancing diagnosis of neurodegenerative disorders through seed amplification testing, today announced a collaboration to expand access to Amprion's SAAmplify–αSYN (CSF) test across the United States. The test (test ID ASYNC) is available today for clients of Mayo Clinic Laboratories through the collaboration that combines the expertise of both organizations to enhance patient care and improve diagnostic accuracy for neurodegenerative diseases.
Performed on cerebrospinal fluid, Mayo Clinic’s RT-QuIC prion test can distinguish prion disease from other types of rapidly progressive dementias to enhance patient care.
Mayo Clinic Laboratories has developed a cutting-edge suite of Alzheimer's disease testing. The newest assays use blood samples, avoiding the need for lumbar punctures to obtain cerebrospinal fluid. The testing suite exemplifies Mayo Clinic Laboratories' innovative business approach. As a platform company, Mayo Clinic is creating a diagnostics ecosystem to meet a wide range of testing needs and help physicians order the right tests for their patients.
In this episode of “Answers From the Lab,” host Bobbi Pritt, M.D., chair of the Division of Clinical Microbiology at Mayo Clinic, is joined by Alicia Algeciras-Schimnich,[...]
Let us help you dial in your patient’s diagnosis.
Take the next step in accessing the industry’s most accurate, clinically relevant plasma and cerebrospinal fluid biomarker evaluations. Schedule an appointment with one of our team members.
Resources
References
- Alzheimer’s disease facts and figures. Alzheimer’s Association. 2022 Alzheimer’s Disease Facts and Figures. https://www.alz.org/alzheimers-dementia/facts-figures
- Alzheimer’s Association. 2023 Alzheimer’s Disease Facts and Figures. Alzheimers Dement. 2023;19(4):1598-1695. doi:10.1002/alz.13016