Most of these patients’ amyloid-β protein level are unknown to their attending physicians since PET-scan costs $3000 to $4000 (without imbursement from CMS) and invasive spinal tap for CSF has low patients’ acceptance. Knowledge of amyloid-β protein level is clinically actionable. JAMA (April 2019) published a CMS-sponsored clinical trial where 11,409 patients with dementia completed PET-scan for amyloid-β. Results showed attending physicians changed management of 61% (6,959) of patients with known amyloid-β information.
In addition to sales to diagnostic companies or hospitals, another opportunity is companion diagnostics for pharmas in characterizing amyloid-β levels of subjects prior to enrollment for Alzheimer's Disease-related clinical trials. Recent interaction with IQVIA, the largest CRO worldwide, confirmed that this is an extremely urgent need for pharmas.