ALZpath inks licensing deal with Roche for Alzheimer’s blood test

Roche to integrate ALZpath’s pTau217 antibody blood test for Alzheimer’s into the Elecsys diagnostics platform.

As promising treatments for Alzheimer’s continue to be developed, accurate diagnostic tools will be essential in helping identify candidates for these therapies and monitoring their efficacy. Addressing this challenge, diagnostics company ALZpath has announced a strategic licensing agreement with pharma giant Roche to integrate its proprietary pTau217 antibody blood test into Roche’s diagnostics platform, Elecsys.

The current gold standard for diagnosing Alzheimer’s involves positron emission tomography (PET) scans and cerebrospinal fluid (CSF) analysis via lumbar punctures. While these methods are highly accurate, they are also invasive, expensive and impractical for widespread screening and diagnosis due to the anticipated scale of the disease’s impact.

Found in blood, ALZpath’s pTau217 antibody can be used to detect the presence and progression of Alzheimer’s with an accuracy comparable to that of PET scans and CSF tests, but without the associated invasiveness and cost. As the global burden of Alzheimer’s continues to rise, a blood-based test not only offers convenience but also makes large-scale screening increasingly more feasible.

ALZpath aims to democratize access to its pTau217 antibody by forming strategic partnerships with global diagnostics leaders like Roche. Via its Elecsys platform, Roche intends to develop a diagnostic blood test utilizing the pTau217 antibody, which will be commercialized as part of an ongoing collaboration between Roche and Eli Lilly.

“The field has been waiting for highly accurate and reliable plasma pTau217 assays on widely available, fully automated commercial testing platforms, and we are thrilled that ALZpath’s proprietary antibody has been selected by Roche to play that vital role on the Elecsys platform,” said Venkat Shastri, CEO of ALZpath. “The broad availability of an easy-to-use diagnostic test can profoundly impact Alzheimer’s disease research, therapeutic clinical trials, and clinical care.”

Alzheimer’s and pTau217

The pTau217 antibody targets phosphorylated tau at residue 217, a critical biomarker for Alzheimer’s disease. Earlier this year, ALZpath published research in JAMA Neurology demonstrated that assays using this antibody deliver diagnostic accuracy on par with PET and lumbar punctures. The ALZpath pTau217 assay has shown up to 96% accuracy in detecting amyloid plaques and 97% accuracy for tau pathology in the brain, outperforming other plasma biomarkers and matching the reliability of CSF biomarkers.

 “Incorporating a diagnostic reagent like the ALZpath pTau217 antibody into widely used diagnostic platforms such as the Roche Elecys could help transform Alzheimer’s disease research, accelerate the evaluation of promising interventions to treat and prevent the disease, and improve the assessment and care of people with memory problems,” said Dr Sterling Johnson, co-author of the study, and an advisor to ALZpath. “With time, the test could ultimately be used to screen and to help avert the clinical onset of Alzheimer’s disease when effective prevention therapies become available.”

Photograph: Poetra.RH/Envato