Alzheimer's Association
FDA's recommendation that individuals be tested for APOE status prior to starting the drug could lead to new regulatory approvals and payor coverage.
Clinicians, Researchers Propose Adding Blood Biomarkers to Alzheimer's Diagnostic Criteria
At the 2023 Alzheimer's Association International Conference in Amsterdam, an international steering committee recommended revised diagnosis guidelines.
Firms including Roche and Quest have moved into the space, providing both a vote of confidence and new competition for smaller players that pioneered it.
Both recent FDA draft guidance and a new research framework encourage the use of biomarker diagnostics to assess Alzheimer's before symptoms emerge.