This site is intended for US Healthcare Professionals only.

Alzheimer’s disease CSF biomarker testing at no charge*

This program provides cerebrospinal fluid (CSF) testing to evaluate the presence of amyloid beta (Aβ) pathology in patients being assessed for the mild cognitive impairment (MCI) and mild dementia clinical stages of Alzheimer's disease (AD).

The Amyloid βeta Confirmed™ program is being offered to help improve patient access to CSF biomarker testing to help support timely and accurate diagnosis of AD.

*The Amyloid Beta Confirmed™ program will cover the cost of Aβ CSF laboratory testing only and does not cover the cost of the lumbar puncture procedure or any other related costs. The lumbar puncture procedure may be covered by your patient’s insurance provider. Healthcare professionals are not permitted to seek reimbursement for the CSF laboratory assay from insurance companies or file claims with any third-party payor, including the Medicare or Medicaid programs or any Medicare Advantage or Medicaid managed care plan. Healthcare professionals who participate in this program have no obligation to recommend, purchase, order, prescribe, promote, administer, use, or support any Biogen product. The program is subject to termination or modification at any time.

How does the Amyloid βeta Confirmed™ program work?

Aβ analysis of a CSF sample can be ordered from participating laboratories. The availability of test ordering through each participating laboratory may vary by state. Please visit the respective participating laboratories' landing page or contact their customer service team for more information.

Each laboratory has its own unique assay, test code, and ordering process. To get started, follow these 3 general steps.

1. Follow the link for the participating lab of your choice to find specific ordering instructions.

2. Place an order using the unique test code provided by your participating lab of choice.

3. Collect CSF sample via lumbar puncture into a low-binding polypropylene tube supplied by your participating lab of choice. Handle and ship sample(s) according to the lab’s specifications.

Labcorp currently does not accept patient
samples from the state of New York.

Find an Aβ diagnostic center with the Alzheimer’s Care Locator

The Alzheimer’s Care Locator can help you find AD specialists and diagnostic sevices your patients may need. If you do not perform lumbar puncture (LP) or have an established referral process, use the Alzheimer’s Care Locator to search for a local diagnostic center that performs LP to obtain CSF samples for Aβ analysis.

Find an Aβ diagnostic center with the Alzheimer's Care Locator

How can Aβ testing help support a diagnosis of AD?

Aβ accumulation in the brain is a defining pathophysiological feature of AD.1 Biomarker evidence of Aβ accumulation may aid in the diagnosis of AD.2

While biomarker testing is not currently routine clinical practice, it may be a useful tool when deemed appropriate by the clinician.2-5

How is Aβ pathology assessed in CSF?

The presence of Aβ pathology in the brain can be assessed by collecting and analyzing CSF. A sample is collected via lumbar puncture between the L3 and L4 vertebrae or the L4 and L5 vertebrae into a low-binding polypropylene tube, which is critical to achieving an accurate test result.6 Test tubes can be obtained from participating laboratories.

Send the CSF sample to one of the participating laboratories for analysis.

Who is the program designed for?


This program is designed for patients being evaluated for the MCI and mild dementia clinical stages of Alzheimer’s disease.

Specimen samples for this program are accepted from the United States (inclusive of US and Puerto Rico). Test requests may only be submitted by qualified, US-based healthcare providers.

Healthcare providers are responsible for ordering testing in accordance with their professional medical judgment and applicable laws.

Privacy Statement

While Biogen provides financial support for this program, all testing is performed by independent, third-party laboratories participating in the program. Biogen receives de-identified patient data from this program, but at no time does Biogen receive patient-identifiable information. Biogen receives information regarding healthcare professionals who use this program, which may include details such as contact information, medical specialty, program utilization data, and the provider's patient–de-identified test results.

Biogen is providing this tool to help you find a practice that fits your patients’ needs. Biogen does not receive payment for providing this information and does not endorse, recommend, or have jurisdiction over or responsibility for the actions of any healthcare professional.

References
  1. Alzheimer’s Association. 2021 Alzheimer’s disease facts and figures. Alzheimers Dement. 2021;17(3). https://www.alz.org/media/Documents/alzheimers-facts-and-figures.pdf. Accessed March 9, 2021.
  2. Albert MS, DeKosky ST, Dickson D, et al. The diagnosis of mild cognitive impairment due to Alzheimer’s disease: Recommendations from the National Institute on Aging-Alzheimer’s Association workgroups on diagnostic guidelines for Alzheimer’s disease. Alzheimers Dement. 2011; 7(3):270–279.
  3. McKhann GM, Knopman DS, Chertkow H, et al. The diagnosis of dementia due to Alzheimer’s disease: recommendations from the National Institute on Aging–Alzheimer’s Association workgroups on diagnostic guidelines for Alzheimer’s disease. Alzheimers Dement. 2011;7(3):263-269.
  4. Shaw LM, Arias J, Blennow K, et al. Appropriate use criteria for lumbar puncture and cerebrospinal fluid testing in the diagnosis of Alzheimer’s disease. Alzheimers Dement. 2018;14(11):1505-1521.
  5. Johnson KA, Minoshima S, Bohnen NI, et al. Appropriate use criteria for amyloid PET: a report of the Amyloid Imaging Task Force, the Society of Nuclear Medicine and Molecular Imaging, and the Alzheimer’s Association. Alzheimers Dement. 2013;9(1):e1-e16.
  6. Vanderstichele H, Bibl M, Engelborghs S, et al. Standardization of preanalytical aspects of cerebrospinal fluid biomarker testing for Alzheimer’s disease diagnosis: A consensus paper from the Alzheimer’s Biomarkers Standardization Initiative. Alzheimers Dement. 2012;8:65-73.