Unlock new therapies for more patients.
New Alzheimer’s therapies are here and offer real hope to patients and families — but only if a patient’s disease is diagnosed in the early disease stages (mild cognitive impairment to mild dementia).¹
Nearly 2,000 patients each day progress from mild to moderate dementia,² which means they’re no longer in the window of opportunity for newer Alzheimer’s therapies.
A timely diagnosis is more important now than ever.
Rely on Elecsys® AD CSF to confirm amyloid positivity
Greater access
Elecsys® AD CSF ratio assays are available on multiple Roche cobas® platforms and can be part of the typical clinical laboratory test menu, the lumbar puncture procedure for CSF collection can be performed in a variety of settings, increasing access to confirmatory testing for patients.
Conclusive and concordant with amyloid PET accuracy
The Elecsys® Phospho-Tau (181P) CSF (pTau181) and β-Amyloid (1-42) CSF II (Abeta 42) and Elecsys® Total Tau CSF (tTau) and β-Amyloid (1-42) CSF II (Abeta 42) ratios return a conclusive result (no intermediate zone) and have a ~90% concordance with amyloid PET. The assays are traceable to reference materials to ensure accuracy.³,⁴
FDA-cleared
Elecsys AD CSF tests are FDA-cleared, and you can count on accurate, consistent results.
Four reasons to partner with your in-house lab on the Elecsys AD CSF assays
Your health system’s core laboratory may already be running Elecsys AD CSF tests or have the capability to do so. If so, you can:
Use the ratio results as an adjunct to other clinical evaluations to detect amyloid pathology: In patients 55 years or older, the CSF assays can conclusively detect amyloid pathology (no intermediate zone), opening access to new Alzheimer’s therapies.³,⁵,⁶
Get fast results: Fast testing turnaround times can make for efficient patient management.
Reduce costs for patients being evaluated for AD: The cost for the AD CSF assays (and the associated lumbar puncture procedure) is estimated to be lower than for an amyloid PET scan. In addition, as volume of requests for CSF testing is expected to increase, running the Elecsys AD CSF test in house will likely result in a lower cost.
Provide broad access to patients: The Elecsys CSF ratio assays are available on multiple cobas platforms and CSF testing can be part of the typical clinical laboratory test menu. Lumbar puncture procedures can be conducted in a variety of settings, which often translates into increased access for patients.
The key to a new kind of conversation about Alzheimer’s disease
The Elecsys β-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSF and Elecsys tTau CSF assays are FDA-cleared in vitro electrochemiluminescence immunoassays for the measurement of the β-Amyloid (1-42) (Abeta42), Phospho-Tau (181P) (pTau181), respectively total-Tau protein concentrations in cerebrospinal fluid (CSF) from adult patients aged 55 years and older being evaluated for Alzheimer’s disease (AD) and other causes of cognitive impairment to generate a pTau181/Abeta42 ratio, respectively a total-Tau/Abeta42 ratio value.³
A positive pTau181/Abeta42 or tTau/Abeta42 ratio result in CSF does not establish a diagnosis of Alzheimer’s disease (AD) and should always be interpreted in conjunction with clinical information.The performance of the test for African-American, Asian, and other races had high uncertainty due to the limited number of patients studied.
Get Elecsys AD CSF testing results quickly and cost effectively
Roche will help you connect with your lab leadership to explore using Elecsys AD CSF tests. Fill out the form and a member of the Roche clinical team will be in touch to discuss next steps.
- Alzheimer’s Disease International. Accessed June 30, 2023.
- Alzheimer’s Association. Accessed June 30, 2023.
- Elecsys® Method Sheet: ms_08821941190, ms_08846693160, ms_08846685190
- Hansson O, et al. Alzheimers Dement. 2018;14(11):1470-1481.
- Cummings, J., Apostolova, L., Rabinovici, G.D. et al. Lecanemab: Appropriate Use Recommendations. J Prev Alzheimers Dis (2023)
- Cognat E, et al. BMJ Open. 2019;9(5):e026380.
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