Beckman Coulter Diagnostics has forged a licensing agreement with ALZpath, a diagnostic tools and solutions developer, for the use of ALZpath pTau217 antibody in a blood-based test for Alzheimer’s disease (AD) diagnosis.
The agreement enables Beckman Coulter Diagnostics to utilise the antibody in a blood-based in vitro diagnostic (IVD) test on its DxI 9000 Immunoassay Analyzer.
The financial terms of the agreement were not disclosed.
The ALZpath pTau217 antibody supports in detecting the presence and progression of AD. It has shown accuracy, sensitivity, and reliability in blood-based assays, ALZpath said.
ALZpath CEO and president Chad Holland said: “Alzheimer’s disease affects tens of millions of people worldwide, but many remain undiagnosed and are consequently unable to be identified for clinical trials or get access to emerging treatments.
“Collaborating with Beckman Coulter to integrate our pTau217 antibody into a highly accurate blood-based test run on their DxI 9000 analysers will significantly expand access to precise testing and early diagnosis for patients around the world.”
Blood-based assays using the proprietary ALZpath pTau217 antibody have shown comparable diagnostic accuracy to traditional methods like PET imaging and cerebral spinal fluid (CSF) testing.
Suitable for a range of clinical settings, these simple and less invasive blood tests offer the advantage of accessibility and affordability, said ALZpath.
The DxI 9000 Immunoassay Analyzer is globally accessible and represents the next-generation platform of Beckman Coulter for immunoassays.
It features the proprietary Lumi-Phos PRO substrate, which facilitates the creation of clinically significant, highly sensitive assays for evolving healthcare requirements.
The DxI 9000 Analyzer is said to offer an extensive core menu of assays to meet diverse clinical needs.
Beckman Coulter chemistry, and immunoassay general manager and senior vice president Kathleen Orland said: “We recognise the critical need for more sensitive, precise, and scalable diagnostic testing for Alzheimer’s disease.
“We selected ALZpath’s pTau217 antibody following rigorous evaluation due to its high performance in detecting amyloid pathology and ability to integrate into our advanced DxI 9000 platform to support broad-based testing.”
The agreement with Beckman Coulter follows a licensing deal that Alzpath inked in June 2024 with Roche for its pTau217 antibody.
Roche will utilise the antibody to develop and market an AD diagnostic blood test, which will be available on the Roche Elecsys platform.
