ALZpath announces Roche agreement for Alzheimer’s blood test

ALZpath, a developer of innovative diagnostic tools and solutions for Alzheimer’s disease and related dementias, has announced a strategic licence agreement with Roche for use of the ALZpath pTau217 antibody to develop and commercialise an Alzheimer’s disease diagnostic blood test that will be offered on the Roche Elecsys platform.

The Roche pTau217 test was recently granted Breakthrough Device designation by the FDA and will be commercialised as part of an ongoing collaboration between Roche and Eli Lilly.

pTau217 is a critical biomarker for detecting the presence and progression of Alzheimer’s disease in blood. Blood-based assays using ALZpath’s pTau217 antibody have been shown to provide the same accuracy and reliability as more expensive and invasive PET imaging or cerebrospinal fluid (CSF) testing, but with the affordability and convenience of a simple, less invasive blood test.

Sterling Johnson, PhD, co-author of a recent JAMA Neurology publication highlighting the sensitivity of ALZpath’s pTau217 assay, and an advisor to ALZpath, said, “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. 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.”

Alzheimer’s disease and related dementias are expected to impact close to 140 million individuals by 2050. Access to faster, affordable, and more reliable and accurate testing will be critical to address the needs of patients and their families. ALZpath is democratising access to its proprietary pTau217 antibody, which can be used across a variety of clinical and research settings. As promising treatments for Alzheimer’s disease emerge, ALZpath is pursuing strategic partnerships with global diagnostic leaders to make available its technology to laboratories worldwide.

“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 at ALZpath. “ALZpath’s expertise in developing novel antibodies for precisely detecting the presence and progression of Alzheimer’s disease in blood, combined with Roche’s leading in vitro diagnostics instrument base, represents a key step toward global availability of testing as treatments emerge. The broad availability of an easy-to-use diagnostic test can profoundly impact Alzheimer’s disease research, therapeutic clinical trials, and clinical care.”


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