Roche announced June 27 that the U.S. FDA has issued 510(k) clearance for the company's CSF Aβ42/total-tau assay to be used for the diagnosis of Alzheimer’s disease in people aged 55 and older. The electrochemiluminescence-based immunoassay runs on Roche’s fully automated Elecsys analyzers, joining their Aβ42/p-tau181 assay that was cleared last year (Dec 2022 news).

The Aβ42, p-tau181, and t-tau immunoassays are used to measure p-tau181/Aβ42 and t-tau/Aβ42 ratios. Values higher than a specified cutoff indicate the presence of amyloid and tau pathology in the brain. The assays are quicker and cheaper than PET scans.

Roche has about 100,000 fully automated analyzers in clinics and hospitals worldwide that can process these assays, opening the diagnostic tools to a wider population.

Other fluid diagnostics are, or may soon be, cleared for Alzheimer’s. In May 2022, the FDA approved Fujirebio’s fully automated CSF Aβ42/40 test to run on that company's benchtop Lumipulse analyzers, which are also widely distributed (May 2022 news). Both Quest Diagnostics, Seacaucus, New Jersey, and C2N Diagnostics, St. Louis, run assays for plasma Aβ42. C2N’s mass spectrometry-based Precivity test, based on plasma Aβ42/40 ratios and ApoE isoform, is approved under federal Clinical Laboratory Improvement Amendments standards, meaning it is certified for use in clinical testing (Nov 2020 news). 

The startup company ALZpath Inc. has tested an assay for plasma p-tau217 in more than 40 cohorts worldwide, and hopes to introduce it to clinical use later this year. This test is available at Quanterix, and is validated for use in clinical trials by drug developers and clinical research organizations.

Roche also has its eye on plasma assays, which skirt the lumbar puncture needed for CSF analysis, a procedure used routinely in Europe but less so elsewhere, particularly in North America. Last July the FDA granted Breakthrough Device Designation for their amyloid plasma panel, which is still in development. Meanwhile, Roche says the CSF t-tau/Aβ42 assay will be available the last quarter of 2023.—Tom Fagan.


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News Citations

  1. Blood Amyloid Test May Help Diagnose Alzheimer’s, but Questions Remain
  2. FDA Approves Fujirebio’s CSF Test for AD—Quest Diagnostic Offers Plasma Test
  3. Plasma Aβ Test Wins Approval—Are p-Tau Tests Far Behind?

External Citations

  1. announced
  2. ALZpath Inc

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