Biopharma only testing
Accelerate research with robust, expert-developed biomarker testing
Mayo Clinic Laboratories’ suite of BioPharma Diagnostics-specific neurology testing includes a full menu of specific and broad-based fluid biomarker assays for dementia and other neurodegenerative conditions.
Backed by ongoing scientific discoveries on the interplay between fluid biomarkers and certain neurological disorders, our tests were developed by clinical specialists and use leading-edge methods to provide accurate answers that propel research initiatives.
To learn more about our testing, view our biopharma-specific test catalog and full test catalog.
Biopharma only Test menu
Dementia biomarkers
Our pioneering testing to detect specific biomarkers associated with Alzheimer's disease and related dementias reflects the latest scientific breakthroughs. Thoughtfully developed by neurology experts, these tests are available exclusively to BioPharma Diagnostics clients to meet their clinical trial needs.
Key testing
- AMYRB | Beta-Amyloid 1-42 and 1-40 with Ratio, BioPharma Diagnostics, Spinal Fluid
- This assay is used for the quantitative measurement of beta-amyloid 1-42 (Aβ42) and beta-amyloid 1-40 (Aβ40) in cerebrospinal fluid (CSF) and calculation of the beta-amyloid ratio (1-42/1-40).
- The use of the Aβ42/40 ratio increases diagnostic accuracy for Alzheimer’s disease versus the use of Aβ42 alone. The Aβ ratio demonstrates high concordance with amyloid positron emission tomography (PET) when distinguishing amyloid deposition due to Alzheimer’s disease from alternative causes of mild cognitive impairment or dementia.
- In addition, the use of the CSF Aβ ratio could partially mitigate the effect of some preanalytical confounders that have been described to alter the results of Aβ42 in CSF.
- This test code is available for BioPharma Diagnostics clients only.
- This assay is used for the quantitative measurement of beta-amyloid 1-42 (Aβ42) and beta-amyloid 1-40 (Aβ40) in cerebrospinal fluid (CSF) and calculation of the beta-amyloid ratio (1-42/1-40).
- B181P | Phosphorylated Tau 181, Plasma
- This assay is used for the quantitative measurement of Tau phosphorylated at threonine 181 (p-Tau181) in human plasma.
- Current research indicates that plasma p-Tau, including p-Tau181, is concordant with amyloid positron emission tomography (PET) and is able to differentiate between Alzheimer’s disease and non-Alzheimer’s neurodegenerative diseases and to predict progression to Alzheimer’s disease.
- Blood-based biomarkers, such as plasma p-Tau, could potentially be used as inclusion criteria or to evaluate target engagement and treatment efficacy, and could further advance the development of disease-modifying treatments in the field of Alzheimer’s disease and related disorders.
- Lumipulse G pTau 181 Plasma is available for BioPharma Diagnostics clients only.
- This assay is used for the quantitative measurement of Tau phosphorylated at threonine 181 (p-Tau181) in human plasma.
- B181C | Phosphorylated Tau 181, Cerebrospinal Fluid
- The p-Tau181 cerebrospinal fluid (CSF) assay is intended to be used as an aid for diagnosis in patients with cognitive impairment who are being evaluated for Alzheimer's disease and other causes of cognitive decline.
- This CSF biomarker supports the probability of Alzheimer’s disease pathology only as an adjunct to other diagnostic evaluations.
- This test, the Lumipulse G pTau 181 CSF, is available for BioPharma Diagnostics clients only.
- For p-Tau181 testing available to Mayo Clinic Laboratories clients, click here.
- The p-Tau181 cerebrospinal fluid (CSF) assay is intended to be used as an aid for diagnosis in patients with cognitive impairment who are being evaluated for Alzheimer's disease and other causes of cognitive decline.
- B217P | Phosphorylated Tau 217, Plasma
- This assay is used for the quantitative measurement of Tau phosphorylated at threonine 217 (p-Tau217) in human plasma.
- Current research indicates that plasma p-Tau, including p-Tau217, is concordant with amyloid status defined by cerebrospinal fluid (CSF) or positron emission tomography (PET), and is able to differentiate between Alzheimer’s disease and non-Alzheimer’s neurodegenerative diseases and to predict progression to Alzheimer’s disease.
- Blood-based biomarkers, such as plasma p-Tau, could potentially be used as inclusion criteria or to evaluate target engagement and treatment efficacy, and could further advance the development of disease-modifying treatments in the field of Alzheimer’s disease and related disorders.
- Lumipulse G pTau 217 Plasma is available for BioPharma Diagnostics clients only.
- This assay is used for the quantitative measurement of Tau phosphorylated at threonine 217 (p-Tau217) in human plasma.
- BAMYP | Beta-Amyloid 1-42 and 1-40 with Ratio (1-42/1-40), Plasma
- The two Aβ peptides evaluated by this assay are 1-40 and 1-42.
- Aβ40 typically exists at a higher physiological concentration than Aβ42. In Alzheimer’s disease, Aβ42 accumulation leads to aggregation into plaques and neurotoxicity.
- Aβ40 is much less prone to aggregation, with levels remaining unchanged when comparing patients with Alzheimer’s disease to healthy individuals.
- Current research indicates that the plasma Aβ 42/40 ratio may be used to predict brain Aβ burden. It could reduce the number of lumbar punctures (for spinal fluid biomarker testing) or amyloid-positron emission tomography (PET) scans in light of clinical trial recruitment and be used as a tool to evaluate target engagement and efficacy of disease-modifying drugs.
- This test code is available for BioPharma Diagnostics clients only.
- The two Aβ peptides evaluated by this assay are 1-40 and 1-42.
- BTBAR | Phosphorylated Tau 217/Beta-Amyloid 1-42 Ratio, Plasma
- This assay measures the ratio of p-Tau217 to Aβ42 in human plasma.
- Blood-based markers such as Aβ42 and p-Tau217 can help support or rule out Alzheimer’s disease in individuals with mild cognitive impairment (MCI) or early dementia. Individuals with an intermediate test result would require confirmatory testing with amyloid-positron emission tomography (PET) imaging or cerebrospinal fluid (CSF) Alzheimer’s disease biomarkers (e.g., CSF p-tau181/Aβ42).
- This test code is available for BioPharma Diagnostics clients only.
- BTTAU | Total Tau, Cerebrospinal Fluid
- The t-Tau cerebrospinal fluid (CSF) assay is intended to be used as an aid for diagnosis in patients with cognitive impairment who are being evaluated for Alzheimer's disease and other causes of cognitive decline.
- This CSF biomarker supports the probability of Alzheimer’s disease pathology only as an adjunct to other diagnostic evaluations.
- Lumipulse G Total Tau CSF is available for BioPharma Diagnostics clients only.
- For t-Tau testing available to Mayo Clinic Laboratories clients, click here.
Learn more View our full suite of dementia testing
Learn more Check out our digital guide to learn more about our full suite of biomarker testing for dementia and related neurodegenerative disorders
Neurodegeneration biomarkers
Emerging research has shown that broad-based biomarkers, such as glial fibrillary acidic protein (GFAP) and neurofilament light (NfL) chain, have applications for a number of neurodegenerative conditions, among them Alzheimer’s disease, multiple sclerosis, ischemic stroke and traumatic brain injury. Our plasma and cerebrospinal fluid (CSF) biomarker tests use the innovative Fujirebio Lumipulse testing platform, which is available exclusively to BioPharma Diagnostics clients, to provide precise answers that advance research projects.
Key testing
- BGFAP | Glial Fibrillar Acidic Protein (GFAP), Plasma
- This assay is used for the quantitative measurement of glial fibrillary acidic protein (GFAP) levels in human plasma.
- GFAP is an astrocytic protein that serves as a key biomarker for astrocytic activity and central nervous system (CNS) integrity. Various neurological disorders — including traumatic brain injury, ischemic stroke, and neurodegenerative diseases — result in astrocytic morphological and functional changes that lead to increased concentrations of GFAP in plasma.
- This test code is available for BioPharma Diagnostics clients only.
- BNFLC | Neurofilament Light Chain, Cerebrospinal Fluid
- This assay is used for the quantitative measurement of neurofilament light (NfL) in human cerebrospinal fluid (CSF).
- Varying NfL levels are an indicator of neuroaxonal damage, irrespective of the cause, and can therefore be associated with a variety of neurological diseases such as multiple sclerosis, amyotrophic lateral sclerosis, frontotemporal dementia, or Alzheimer's disease, as well as acute situations such as traumatic brain injury and others.
- NfL is considered a promising biomarker for disease activity, progression, prognosis, and monitoring the effectiveness of therapies. As NfL can be measured in both CSF and blood, it holds great potential for clinical trials and routine clinical use.
- Lumipulse G NfL CSF is available for BioPharma Diagnostics clients only.
- BNFLP | Neurofilament Light Chain, Plasma
- This assay is used for the quantitative measurement of NfL in human plasma and serum.
- Varying NfL levels are an indicator of neuroaxonal damage, irrespective of the cause, and can therefore be associated with a variety of neurological diseases such as multiple sclerosis, amyotrophic lateral sclerosis, frontotemporal dementia, or Alzheimer's disease, as well as acute situations such as traumatic brain injury and others.
- NfL is considered a promising biomarker for disease activity, progression, prognosis, and monitoring the effectiveness of therapies. As NfL can be measured in both cerebrospinal fluid (CSF) and blood, it holds great potential for clinical trials and routine clinical use.
- Lumipulse G NfL Blood is available for BioPharma Diagnostics clients only.