Agreement Supports pTau217-Based Alzheimer’s Blood Test Development

As disease-modifying therapies for Alzheimer’s disease expand, accessible diagnostics are increasingly needed to identify patients earlier. Current confirmatory methods, including PET imaging and cerebrospinal fluid analysis, are costly, invasive, and difficult to scale. A new global licensing agreement now supports development of a blood-based in vitro diagnostic test for Alzheimer’s disease incorporating a phosphorylated tau 217 antibody.

ALZpath’s proprietary phosphorylated tau 217 (pTau217) antibody is being licensed to Abbott for incorporation into the development of an in vitro diagnostic test for Alzheimer’s disease. The test would be designed for use on Abbott’s Alinity ci-series systems, which represent one of the largest installed bases of immunoassay instruments worldwide. The collaboration is intended to help enable earlier Alzheimer’s diagnosis at global scale.

The proposed immunoassay integrates ALZpath’s pTau217 antibody to detect Alzheimer’s disease biology in blood, aligning with the growing role of blood-based biomarkers in clinical pathways. By leveraging widely deployed analyzers, the approach is positioned to support routine clinical workflows once developed, offering laboratories an avenue to expand access beyond specialized imaging and lumbar puncture. The companies highlighted that blood-based biomarkers may also play a role in monitoring disease progression and treatment response in routine practice.

ALZpath reports that its pTau217 antibody is among the most clinically validated for detecting Alzheimer’s pathology. It is backed by more than 200 peer-reviewed publications across 18 countries and has demonstrated high accuracy and sensitivity in identifying Alzheimer’s disease biology. The agreement underscores a strategy to scale blood-based testing as an alternative to positron emission tomography and cerebrospinal fluid analysis in appropriate clinical settings.

“This agreement further strengthens ALZpath's leadership in blood-based Alzheimer's testing and reinforces our position as the foundational component supporting the overwhelming majority of the pTau217 IVD market,” said Mike Banville, CEO of ALZpath. “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. Together with our diagnostic partners, we remain focused on bringing our highly accurate and sensitive antibody into routine care, including primary care, to reach patients in need.”

“Abbott has spent more than a decade advancing brain health science to give clinicians earlier, clearer answers,” said John Frels, vice president of research and development in Abbott's Core Diagnostics business. “Our work – including pioneering the first FDA cleared rapid blood test that helps assess mild traumatic brain injuries by providing objective biomarker data – shows what's possible when we deepen our understanding of the brain. Collaborations like this are accelerating the next era of Alzheimer's disease research, clinical trials for therapies and ultimately patient care.”