ALZpath intends to develop and validate (using proprietary reagents), a plasma pTau217 laboratory developed test (LDT) and launch for clinical use. Using this LDT, ALZpath will generate clinical evidence to support the ALZpath pTau217 LDT context of use and establish reference intervals across diverse populations with co-morbidities. Additionally, ALZpath will develop a reimbursement strategy to support a new test-specific code for the ALZpath pTau217 assay. Finally, ALZpath will develop a strategy to bridge from the LDT to an IVD.