Abbott and ALZpath have entered into a licensing agreement that could further accelerate the adoption of blood-based Alzheimer's disease testing in clinical laboratories. Under the agreement, Abbott will incorporate ALZpath's proprietary phosphorylated Tau 217 (pTau217) antibody into the development of an in vitro diagnostic (IVD) test for Alzheimer's disease on the company's Alinity ci-series immunoassay systems.
For clinical laboratory professionals, the collaboration represents another step toward bringing Alzheimer's biomarker testing into routine laboratory workflows. The announcement also reflects the increasingly aggressive push by IVD manufacturers to establish a foothold in what is emerging as one of diagnostics' fastest-growing testing markets.
Competition intensifies in Alzheimer's diagnostics
"This agreement further strengthens ALZpath's leadership in blood-based Alzheimer's testing," CEO Mike Banville said in a statement. "As blood-based biomarkers become central to how Alzheimer's disease is detected and managed, partnering with a global healthcare leader like Abbott can enable high-performance testing to reach clinicians and patients around the world at scale."
Multiple manufacturers have announced new assays, partnerships, and regulatory milestones recently, driven by growing demand for less invasive testing and the availability of disease-modifying therapies that depend on earlier identification of eligible patients. Reported on in June 2025 in Dark Daily, the U.S. Food and Drug Administration cleared Fujirebio's Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio as the first blood-based IVD test to aid in identifying amyloid pathology associated with Alzheimer's disease. Since then, companies across the diagnostics industry have continued expanding their Alzheimer's testing portfolios through new product development and commercialization efforts.
Earlier this month, Dark Daily’s sibling publication Today’s Clinical Lab reported that blood-based biomarkers are rapidly changing how Alzheimer's disease is diagnosed by offering a less invasive, more accessible alternative to PET scans and cerebrospinal fluid testing. The biomarkers, particularly pTau217, can help identify the underlying pathology of Alzheimer's earlier in the disease process, enabling faster diagnosis, improved patient selection for disease-modifying therapies, and broader adoption of testing in routine clinical laboratories. As more assays receive regulatory approval and validation, blood-based testing is expected to become an increasingly important part of Alzheimer's care.
