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ACCESS BIOMARKER COLLECTION


An ACCESS Biomarker Collection collaboration with Beckman Coulter provides you with a neurodegenerative disease research roadmap that centers on four key areas spanning our portfolio of diagnostic solutions:

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Reliable, streamlined laboratory workflows

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Increased testing sensitivity

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Our pipeline of innovative biomarkers

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The power of Danaher Business System (DBS)

8. WHO. Dementia. World Health Organization. 2025, https://www.who.int/news-room/fact-sheets/detail/dementia
9. Gauthier S, Rosa-Neto P, Morais J, Webster C. World Alzheimer Report 2021: Journey through the Diagnosis of Dementia. London, England: Alzheimer’s Disease International; 2021.

The Challenge: Current Standard of Care Diagnostics are not Scalable


The current methods of testing to accurately detect elevated levels of amyloid plaque are inherently limited in their ability to scale.

Positron Emission Topography (PET) scanning

  • Expensive
  • Patient access limited by PET scanner installation

Cerebral Spinal Fluid (CSF) testing with mass spectrometry

  • Expensive
  • Time consuming
  • Requires lumbar puncture expertise
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The Solution: A More Accessible Standard of Care


Blood-based biomarker testing offers the patient accessibility and cost efficiency benefits necessary to accelerate the move from diagnostic to therapeutic availability.

Blood-based biomarker immunoassay testing

  • Inexpensive
  • Low-risk
  • Potentially scalable on existing diagnostic platforms

How Pharma Investment is Opening the Floodgates


Over the past 30 years, the pharma industry has invested more than $42.6 billion in Alzheimer’s disease therapeutic clinical trials.

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187 Alzheimer’s therapeutic clinical trials ongoing in 202410

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The leading indicators of diagnostic demand indicate an immense potential need

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90 Phase 2 trials
48 Phase 3 trials10
10. Alzheimer’s Disease Drug Development Pipeline: 2024

“Alzheimer’s Association Releases Its First Clinical Practice Guideline (CPG) for Blood-Based Biomarker Tests”


At AAIC (Alzheimer’s Association International Conference) 2025, the Alzheimer’s Association unveiled Clinical Practice Guidelines (CPG) focused on the role of blood-based biomarker tests in assessing levels of Alzheimer’s disease pathology in people with cognitive impairment.

The following CPG recommendations apply to patients with cognitive impairment being seen in specialized care for memory disorders:


BBM tests with ≥90% sensitivity and ≥75%

At BBM tests with ≥90% sensitivity and ≥75% specificity can be used as a triaging test, in which a negative result rules out Alzheimer’s pathology with high probability. A positive result should also be confirmed with another method, such as a cerebral spinal fluid (CSF) or amyloid positron emission tomography (PET) test.

Blood-Based Biomarker (BBM) tests with ≥90%

Blood-Based Biomarker (BBM) tests with ≥90% for both sensitivity and specificity can serve as a substitute for PET amyloid imaging or CSF Alzheimer’s biomarker testing.
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To learn more about the expanding role of blood-based biomarkers in Alzheimer’s disease research and how ACCESS to the NeuroABC Biomarker research use only collection positions your lab for the future, request a consultation with a Beckman Coulter Neurodegenerative disease biomarker specialist.

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Alzheimer’s Association. Alzheimer’s Association Releases Its First Clinical Practice Guideline for Blood-Based Biomarker Tests. Alzheimer’s Association.

Why p-Tau217?


Plasma p-Tau217 levels have shown correlation with amyloid pathology, which has implications for identifying neurodegenerative diseases such as Alzheimer’s disease. Measuring p-Tau217 may help to further research into AD pathology, flag samples from those with early-stage AD pathology, and help distinguish AD from other forms of dementia.

An ACCESS Biomarker Collection collaboration with Beckman Coulter is a giant step towards blood-based Alzheimer’s disease testing that:

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Is sensitive, accurate and reliable in detecting targeted NDD biomarkers in blood

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Is easily accessible to patients and clinicians through a widespread installed base

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Requires no special labor skills compared to other routine diagnostic tests

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Is high-throughput

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Leverages workflow automation

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Is affordable relative to alternate testing methods

The Key to Diagnostic Innovation


By partnering with clinical and research experts, Beckman Coulter has created an NDD RUO immunoassay development strategy that is producing a best-in-class biomarker pipeline.

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Blood-based Neurodegenerative Disease Assays (RUO)

p-Tau217 IFU DOWNLOAD PDF
GFAP IFU DOWNLOAD PDF
NfL IFU DOWNLOAD PDF
APOE ε4 IFU DOWNLOAD PDF
β-Amyloid 1-42 IFU COMING SOON
BD-Tau IFU COMING SOON

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Research Use Only Assays in Development

MTBR-Tau (CSF-based)
TDP-43

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Assay has been granted Breakthrough Device Designation (BDD) from the U.S. FDA

p-Tau217/ß-AmyIoid 1-42 Plasma Ratio*

Choose a Partner Who’s Rapidly Changing the Research and Diagnostics Landscape


Superior Precision.
Unprecedented Reproducibility.


The population is aging and testing volume is poised to explode. In a field that’s advancing so rapidly, you need to be ready for what’s next. Now, there’s a way to position your lab for the future while supporting today’s core operations!

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Insourcing NDD biomarkers decreases time to deliver test results
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Beckman Coulter has an impactful, future-looking neurodegenerative pipeline on a high throughput, highly precise and reproducible platform
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You have the flexibility to run assays on two different solutions­—a low volume option and a medium/high throughput option

Scalable Neurology Assay Solutions to Match Your Lab


Our RUO neurology assays run on the following Beckman Coulter Immunoassay Analyzers:

Access 2

Access 2*
Immunoassay Analyzer

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DxI 9000

DxI 9000
Immunoassay Analyzer

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*p-Tau 217 and ß-Amyloid 1-42 only run on DxI 9000 Analyzer

Let’s Talk ACCESS to NeuroABC


See what ACCESS to the NeuroABC biomarker collection can mean for your organization. Request a no-obligation consult with a Beckman Coulter neurodegenerative solutions specialist.