- FDA Approves Fujirebio’s CSF Test for AD—Quest . . . - ALZFORUM
Fujirebio’s CSF Aβ test was approved through the FDA’s De Novo pre-market review pathway, which is used for devices or assays with little risk to the patient The test, an immunoassay run on the fully automated Lumipulse platform, is intended for use in people 55 or older with cognitive impairment
- A First: FDA Approves Alzheimer’s Blood Test | ALZFORUM
The FDA ruled that Fujirebio’s new plasma assay is “substantially equivalent” to the company’s previously cleared CSF test In multicenter testing on 499 cognitively impaired people, the blood test had a positive predictive value of 92 percent, and a negative predictive value of 97 percent, for detecting plaques found by amyloid PET
- Two New p-Tau217 Blood Tests Join a Crowded Field
01 Dec 2023 The blood-based p-tau marker field is getting pretty busy In addition to existing tests by Fujirebio, Lilly, Janssen, and Meso Scale Discovery, C2N debuted a new CLIA-approved mass spectrometry-based test last August, while ALZPath Inc still plans to offer its immunoassay for clinical use in 2023
- Some Alzheimer’s Blood Tests Are Racing Toward IVD Certification
For Fujirebio, this means using the p-tau217 Aβ1-42 ratio [Courtesy of Manu Vandijck, Fujirebio ] As with every test, the positive and negative predictive value of a p-tau217 test, PPV and NPV for short, will depend in part on the prevalence of the tested condition in the population being screened (discussed in Aug 2024 conference news )
- In Head-to-Head Testing, P-Tau217 Tau217 Comes Out on Top . . . - ALZFORUM
Here, too, the %p-tau217, as measured by C2N, generally outperformed the immunoassays It identified amyloid-positive people with an accuracy of 0 87 The ALZpath and Fujirebio p-tau217 assays came in a close second, with accuracies of 0 84 and 0 83, respectively, followed by Janssen’s 0 82
- Looking Good: Immunoassays for Blood Markers | ALZFORUM
Palmqvist’s team evaluated the fully automated Fujirebio Lumipulse assay using plasma samples from 1,767 people in one primary and four secondary care centers in Europe They first established cutoffs for AD pathology based on data from 337 samples from a secondary care center at Malmö, which is part of the Swedish BioFinder study
- FDA Clears Roche’s CSF Aβ42 tTau Assay - ALZFORUM
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
- Blood Amyloid Test May Help Diagnose Alzheimer’s, but . . . - ALZFORUM
While blood tests are still wending their way through this kind of applied research, CSF Aβ assays are formally ready for prime time Fujirebio’s Lumipulse Aβ42 40 test got FDA approval in May (May 2022 news) Earlier this month, FDA similarly greenlighted Roche’s Elecsys p-tau181 Aβ42 assay (press release)
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