ALZpath鈥檚 pTau217 antibody is drawing significant attention at this year鈥檚 Alzheimer’s Association International Conference (AAIC), taking place in Toronto, Canada, from 27-31 July. The biomarker features in seven presentations and 30 posters, reflecting growing momentum for its use in Alzheimer鈥檚 disease research and clinical development.
According to ALZpath, since its release in 2023, pTau217 has been part of over 150 scientific presentations and posters and 90 publications across 18 countries.
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New real-world data presented by Roche at this year鈥檚 AAIC confirmed that its blood-based biomarker, Elecsys pTau217, provides comparable results to PET scan and cerebrospinal fluid (CSF) diagnostics for rule-in and rule-out diagnosis of amyloid pathology.
Elecsys pTau217 received a breakthrough device designation from the US Food and Drug Administration (FDA) in April 2024.
Roche Diagnostics CEO, Matt Sause, commented: 鈥淓lecsys pTau217 has the potential to transform the diagnosis of Alzheimer’s disease and provide clear answers to caregivers, patients, and their families.鈥�
Cognition Therapeutics presented results from its Phase II SHINE study (NCT03507790) of zervimesine in Alzheimer鈥檚 disease. Patients with lower p-tau217 levels were found to have a more robust response to zervimesine compared to those with higher p-tau217 levels, regardless of their mini mental state exam (MMSE) scores.
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By GlobalDataDr Anthony Caggiano, Cognition鈥檚 chief medical officer and head of R&D, commented: 鈥淭his was an important finding as we now know we can identify patients who are more likely to benefit from zervimesine treatment through a simple blood test for p-tau217.鈥�
Acumen Pharmaceuticals presented data revealing that implementing a blood-based pTau217 assay into enrolment screening for its Phase II ALTITUDE-AD trial (NCT06335173) evaluating sabirnetug in patients with early Alzheimer鈥檚 disease reduced costs by approximately 40% at sites in the US and Canada.
Acumen said the screening approach using the pTau217 assay helped achieve strong enrolment rates and reduce unnecessary amyloid PET scans and lumbar puncture procedures for potential participants. 48% of participants met the pTau217 threshold required for confirmatory testing, while 81% of participants who passed the initial screening met amyloid positivity eligibility requirements.
Measuring tau pathology in individuals with or without cognitive impairment
Elsewhere at this year鈥檚 AAIC, Veravas demonstrated the potential of its VeraBIND Tau Assay in measuring active tau pathology in individuals both with and without cognitive impairment.
According to Veravas, unlike currently available tests that quantify biomarker levels, VeraBIND measures the pathological binding activity between hyperphosphorylated tau to provide a more direct measure of disease activity, observable years before the symptoms of Alzheimer鈥檚 disease may appear.
Key findings from two independent analyses of Veravas, conducted by Dr Bernard Hanseeuw, associate head of the Memory Clinic, Neurology Department at Saint Luc University Hospital, Belgium, and Lisa Quenon, a postdoctoral researcher at Universit茅 catholique de Louvain, Belgium were presented at AAIC 2025.
Key insights from Hanseeuw鈥檚 analysis revealed that diagnostic accuracy was similar in cognitively impaired/unimpaired individuals, due to VeraBIND鈥檚 high sensitivity in the early PET-based Braak-like stages 1-3 of tau aggregation. In contrast, Hanseeuw said current plasma tau methods, such as pTau217, tend to be driven by sensitivity at latter Braak stages 4-6, when symptoms are already present.
Quenon鈥檚 analysis confirmed that VeraBIND correctly identified MK6240-positive individuals, with or without cognitive impairment and regardless of amyloid status.
The current potential of blood-based Alzheimer鈥檚 disease diagnostics
According to GlobalData medical analyst Selena Yu, the primary consideration in advancing blood-based in vitro diagnostic (IVD) tests for Alzheimer’s disease is the reduction of waiting time.
“Typically, CT and PET scans are employed to diagnose patients with Alzheimer’s. This is due to the fact that Alzheimer’s, along with other conditions that lead to cognitive decline, often remains undetected in the early stages or is broadly categorised under the general term “dementia,” Yu said.
“Consequently, this lack of specificity prevents patients from receiving precise care, resulting in years without a definitive diagnosis and appropriate treatment. Therefore, IVD tests in this domain that can identify Alzheimer’s years before a formal diagnosis have the potential to delay the severe onset of the disease.”
Reacting to the continued rise of blood-based diagnostics in Alzheimer鈥檚 disease, Dr Andrew Thompson, director of therapy research and analysis in medical devices for GlobalData commented: 鈥淚VD test needs to fit into existing clinical diagnostic pathways, and these are quite well established for AD; a combination of PET scans and cognitive impairment tests (“Mini Mental”).
鈥淐urrently, depending on when the patient is identified, the clinical approach in Alzheimer鈥檚 disease is mitigation; administering various medications that might slow progression. Often though, patients are not diagnosed until late into the illness, following some personal crisis.鈥�
Thompson hastened cautious optimism around the development of blood-based Alzheimer鈥檚 disease diagnostics, noting that 鈥渋ll-advised鈥� prostate-specific antigen (PSA) testing has led to a 鈥渕assive overdiagnosis鈥� in prostate cancer.
鈥淟ooking at development for early detection/screening assay, there are only 22 in active development, and of these, 15 are intended only for the US, four for Korea/China, and three for Europe/UK,鈥� Thompson said.
鈥淭hat could be interpreted to suggest that, within current diagnostic pathways for Alzheimer鈥檚 disease, there isn’t that much of a market for early detection of Alzheimer鈥檚 disease through a blood test.鈥�
鈥淗owever, that might change if there is a breakthrough in the prevention or treatment of Alzheimer鈥檚 disease,鈥� Thompson concluded.
