ARIA risk assessment and anti-amyloid therapy eligibility
Is plasma apoE proteotyping the answer?
The pre-treatment workup for Alzheimer's anti-amyloid therapies centers on confirming amyloid-beta pathology, increasingly via plasma biomarkers like p-tau217. Genetics matter too: APOE ε4 status informs ARIA risk counseling, shared decision-making, and in some countries, eligibility determination.
That second step has traditionally meant a separate genotyping test, a different sample, a different platform, and often a different referral pathway.
Our study, published in the Canadian Journal of Neurological Sciences, evaluates whether plasma apoE4 proteotyping, measuring isoform-specific apoE proteins on an automated immunoassay analyzer, can reliably determine APOE ε4 status. The high-throughput assay demonstrated high concordance with PCR-based genotyping across non-carriers and heterozygotes, the groups eligible for anti-amyloid therapy in Canada, the UK, and across the European Union.
P-tau217 and apoE4 proteotyping can be run from the same blood sample on the same analyzer. For labs managing growing demand for Alzheimer's biomarker testing, consolidating these two steps onto one platform may reduce operational complexity and staffing requirements. For patients, it may mean a simpler pathway and faster time to eligibility determination.
#AlzheimersDisease #Neurology #APOE4 #Proteotyping #ptau217 #Biomarkers #AntiAmyloidTherapy #Lecanemab #Donanemab #ARIA #LaboratoryMedicine #Dementia
