![]() ![]() P-tau 217 had the strongest predictive value for amyloid-beta positivity, reaffirming other research that has identified it as a promising blood-based biomarker and which some experts say may eventually be used as a standalone confirmatory test for brain amyloid positivity. In particular, blood tests for amyloid-beta 42/40 ratio, phosphorylated-tau 181, and phosphorylated-tau 217 predicted the likelihood that a patient would have beta-amyloid plaque in their brain as detected by conventional diagnostics. The study authors found a strong correlation between results from several blood tests and the presence of beta-amyloid plaque as determined by the standard testing methods. The biomarkers from blood tests were also gauged at CLIA-certified labs operated by C2N Diagnostics, Quanterix, and Eli Lilly. In this study, researchers compared results of multiple blood-based biomarker tests to either results from brain PET scans with Eli Lilly's Amyvid (florbetapir F-18) radiotracer or cerebrospinal fluid (CSF) assays that were sent to a CLIA-certified lab at Quest Diagnostics for analysis. The analysis was funded by AbbVie, the Alzheimer's Drug Discovery Foundation, Aural Analytics, Biogen, Cognivue, C2N, Gates Ventures, Linus Health, Merck, Quanterix, Retispec, and Roche. The study comprises data from more than 1,000 people in the US with mild Alzheimer's, mild cognitive impairment, and healthy cognition. The latest publication contains the first key analysis from the Bio-Hermes study, which the GAP Foundation and a consortium of about 20 biopharmaceutical, diagnostic, and nonprofit partners launched to research new biomarkers for diagnosing Alzheimer's. Separately, Eli Lilly has said it is seeking FDA approval for its anti-amyloid Alzheimer's drug donanemab. ![]() Last year, the US Food and Drug Administration approved Leqembi, which is indicated for patients with early-stage Alzheimer's, who are confirmed to have elevated levels of beta-amyloid plaque. Identifying blood-based biomarkers for beta-amyloid has been a key area of interest in the life sciences industry, as the increasingly crowded market for anti-amyloid-targeted drugs is expected to drive demand for beta-amyloid testing. "Blood-based tests will be less expensive and much easier for patients to access," said Richard Mohs, CSO at the nonprofit Global Alzheimer's Platform (GAP) Foundation and first author on the paper, which was published in the journal Alzheimer's & Dementia. Moreover, experts hope that one day, these blood tests could be standalone diagnostics for identifying which patients have Alzheimer's and can receive anti-amyloid drugs like Biogen and Eisai's Leqembi (lecanemab), which require patients to have a confirmed presence of amyloid pathology. CSF analysis requires a lumbar puncture, which patients may consider invasive and be hesitant to receive.īlood tests for specific protein biomarkers may have the near-term potential of prescreening individuals suspected of having Alzheimer's before they undergo a confirmatory PET scan or CSF analysis, particularly in the context of clinical trials. ![]() For example, PET scans are expensive, and not all patients have access to healthcare facilities with the requisite equipment and specialists on staff. However, these modalities have their drawbacks. PET scans and cerebrospinal fluid (CSF) analyses are highly accurate and established methods of identifying elevated levels of beta-amyloid, a hallmark of Alzheimer's. NEW YORK – Results from blood-based biomarker tests correlated with the presence of beta-amyloid detected using established Alzheimer's disease diagnostics, according to a study published Wednesday. ![]()
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