Dementia

BioPharma Diagnostics offers pioneering testing to detect newly discovered biomarkers associated with Alzheimer's disease and other neurodegenerative conditions. Our testing reflects the latest scientific breakthroughs, was thoughtfully developed by neurology experts, and is available exclusively to BioPharma Diagnostics clients to meet clinical trial needs.

Key testing

• AMYRB (Abeta 42/40 Ratio CSF)
  • This assay is used for the quantitative measurement of beta-amyloid 1-42 andbeta-amyloid 1-40 in cerebrospinal fluid (CSF) and calculation of the beta-amyloid ratio (1-42/1-40). The use of the beta-amyloid ratio (1-42/1-40) increases diagnostic accuracy for Alzheimer’s disease versus the use of beta-amyloid 1-42 alone. The beta-amyloid ratio (1-42/1-40) 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 beta-amyloid ratio (1-42/1-40) could partially mitigate the effect of some preanalytical confounders that have been described to alter the results of beta-amyloid 1-42 in CSF.
  • This test code is available for BioPharma Diagnostics clients only.
• Neurofilament Light (NfL), Cerebrospinal Fluid (CSF)
  • This assay is used for the quantitative measurement of neurofilament light (NfL) in human 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 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.
• Neurofilament Light (NfL), 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 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 Blood is available for BioPharma Diagnostics clients only.
• Total Tau, Cerebrospinal Fluid (CSF)
  • The t-Tau 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.
• Phosphorylated Tau 181, Cerebrospinal Fluid (CSF)
  • The p-Tau181 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 pTau 181 CSF is available for BioPharma Diagnostics clients only.
  • For p-Tau181 testing available to Mayo Clinic Laboratories clients, click here.
• 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 PET, and is able to differentiate between Alzheimer’s disease and non-Alzheimer’s disease 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.
• 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 CSF or PET, and is able to differentiate between Alzheimer’s disease and non-Alzheimer’s disease 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.
• β-Amyloid 1-42, Plasma
  • This assay is designed for the quantitative measurement of β-amyloid 1-42 in human plasma. CSF biomarker analysis has become part of routine clinical testing, however, measuring biomarkers in plasma could improve future test strategies. Blood-based biomarkers can reduce the number of lumbar punctures (for CSF biomarker testing) or Aβ-PET scans in clinical trial recruitment and can be used as a tool to evaluate target engagement and efficacy of disease-modifying drugs.
  • Lumipulse G β-Amyloid 1-42 Plasma is available for BioPharma Diagnostics clients only.
• β-Amyloid 1-40, Plasma
  • This assay is designed for the quantitative measurement of β-amyloid 1-40 in human plasma. Current research indicates that plasma β-amyloid1-42/β-amyloid1-40 ratio has the potential to be used in clinical settings and within clinical trials to predict brain β-amyloid burden. Blood-based biomarkers can reduce the number of lumbar punctures (for CSF biomarker testing) or Aβ-PET scans in clinical trial recruitment and can be used as a tool to evaluate target engagement and efficacy of disease-modifying drugs.
  • Lumipulse G β-Amyloid 1-40 Plasma is available for BioPharma Diagnostics clients only.