Beckman Coulter Licenses Alzpath's Proprietary P-tau 217 Antibody to Develop Alzheimer's Blood Test

Cognitive assessments have traditionally been the primary method for diagnosing Alzheimer’s disease, but this approach has its limitations as symptoms become apparent only after significant brain changes have occurred. Historically, a definitive diagnosis of Alzheimer’s disease could only be confirmed through an autopsy. In the last two decades, advanced brain imaging techniques such as PET, CT, and MRI have been developed to aid in the diagnosis of Alzheimer’s disease more reliably; however, these methods are costly, expose patients to radiation, and are not accessible to everyone. In search of a more accessible and straightforward method to assess brain health, the focus has shifted towards biomarkers. The detection of biomarkers in blood is now seen as the future of Alzheimer’s disease diagnosis. Now, a new collaboration for the use of a proprietary antibody to detect a crucial biomarker for Alzheimer's through a blood test marks a significant step forward in diagnosing the disease.

Beckman Coulter Diagnostics (Brea, CA, USA) has signed a licensing agreement with ALZpath Inc. (Carlsbad, CA, USA) to use its top-tier ALZpath pTau217 antibody in a blood-based in vitro diagnostic (IVD) test on its DxI 9000 Immunoassay Analyzer. This proprietary ALZpath pTau217 antibody, employed in blood-based assays, has demonstrated high diagnostic accuracy, sensitivity, and reliability in identifying the presence and progression of Alzheimer's disease—information that is increasingly vital for clinicians and researchers as new treatment options become available.

Blood-based assays using the ALZpath pTau217 antibody offer diagnostic accuracy comparable to traditional methods like PET imaging and cerebral spinal fluid (CSF) testing, but they are more accessible and affordable, involving a simple, less invasive blood test that can be performed in various clinical settings. The DxI 9000 Immunoassay Analyzer, available worldwide, is Beckman Coulter's latest immunoassay platform. It features the unique Lumi-Phos PRO substrate, facilitating the development of clinically relevant, highly sensitive assays that meet the evolving demands of healthcare. The DxI 9000 combines this enhanced sensitivity with leading throughput, reliability, reproducibility, and quality in core laboratory operations, along with a comprehensive menu of tests.

"We recognize the critical need for more sensitive, precise, and scalable diagnostic testing for Alzheimer's disease," said Kathleen Orland, senior vice president, general manager, Chemistry, and Immunoassay for Beckman Coulter Diagnostics. "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. We are excited about the combination of ALZpath and Beckman Coulter innovations coming together to develop a new fully automated, high throughput, blood-based Alzheimer's disease test for the millions of patients who suffer from dementia worldwide."

"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," added Chad Holland, CEO and president at ALZpath. "Collaborating with Beckman Coulter to integrate our pTau217 antibody into a highly accurate blood-based test run on their DxI 9000 analyzers will significantly expand access to precise testing and early diagnosis for patients around the world."

Related Links:
Beckman Coulter Diagnostics 
ALZpath Inc.