Unlocking ocular biomarkers for early detection of Alzheimer's disease.

Abstract

Recent evidence suggests that ocular testing holds promise as a non-invasive and cost-effective method for the early detection of Alzheimer's disease (AD). After interviews with neurologists, optometrists, primary care physicians, and ophthalmologists, the potential for ocular biomarker testing to become a standard clinical practice in the future was assessed. Ocular tests offer a non-invasive alternative to blood-based testing, capturing a substantial niche of ≈ 4 to 8 million individuals in the United States during routine eye exams. Technical requirements for broad adoption include high accuracy comparable to blood-based tests and 510(k) clearance. Ocular biomarker technology must meet the practical requirements of optometrists and ophthalmologists, including ease of implementation, automation, and a clear path to profitability. A sufficient body of evidence to support guideline inclusion, reimbursement, and clinical actionability will facilitate the adoption. As the field evolves, advances such as earlier detection of preclinical AD may further expand the role of ocular testing. HIGHLIGHTS: Ocular biomarkers offer another non-invasive alternative to blood-based Alzheimer's disease testing. Wide adoption will require accuracy akin to blood-based tests and 510(k) clearance. Ocular screening could benefit ≈ 4 to 8 million US individuals conducting routine eye exams. Current ocular offerings remain nascent, and advances could expand this reach. New technology must show ease of implementation, automation, and a path to profit.