ALZpath, Inc., a leading developer of innovative diagnostic tools and solutions for Alzheimer’s disease and related dementias, announced  that it has signed a licensing agreement with Beckman Coulter Diagnostics, a global leader in clinical diagnostics, for use of its best-in-class ALZpath pTau217 antibody in a blood-based in vitro diagnostic (IVD) test on its DxI 9000 Immunoassay Analyzer to advance Alzheimer’s disease diagnosis.

The proprietary ALZpath pTau217 antibody, used in blood-based assays, has displayed high diagnostic accuracy, sensitivity, and reliability in detecting the presence and progression of Alzheimer’s disease – a critical need for clinicians and researchers as new treatments become more widely available to patients.

“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,” said 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.”

Blood-based assays, utilizing the ALZpath pTau217 antibody, have demonstrated similar diagnostic accuracy as traditional methods, such as PET imaging and cerebral spinal fluid (CSF) testing, but with the accessibility and affordability of a simple, less invasive blood test that can be administered in a variety of clinical settings.

“We recognize the critical need for more sensitive, precise, and scalable diagnostic testing for Alzheimer’s disease,” added 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.”

Globally available, the DxI 9000 Immunoassay Analyzer is Beckman Coulter’s next generation immunoassay platform featuring the proprietary Lumi-Phos PRO substrate that enables development of clinically relevant, high sensitivity assays to support evolving healthcare needs. The DxI 9000 Analyzer combines this high sensitivity with market leading core laboratory throughput, reliability, reproducibility, quality, and an extensive core menu.