Summary: ALZpath entered a strategic license agreement with Roche to develop and commercialize a blood test for Alzheimer’s diagnosis using the pTau217 antibody on the Roche Elecsys platform.
Takeaways:
- ALZpath and Roche collaborate to create a blood test for Alzheimer’s diagnosis, utilizing the pTau217 antibody on the Elecsys platform.
- The Roche pTau217 test, granted Breakthrough Device designation by the FDA, offers a less invasive, cost-effective alternative to PET imaging and CSF testing.
- This collaboration aims to democratize access to Alzheimer’s diagnostics, potentially transforming research, clinical trials, and patient care worldwide.
ALZpath, a developer of diagnostic tools and solutions for Alzheimer’s disease and related dementias, announced a strategic license agreement with Roche for use of the ALZpath pTau217 antibody to develop and commercialize 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 commercialized as part of an ongoing collaboration between Roche and Eli Lilly.
The pTau217 Biomarker
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 cerebral spinal fluid (CSF) testing, but with the affordability and convenience of a simple, less invasive blood test.
“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,” says Sterling Johnson, PhD, co-author of a recent JAMA Neurology publication highlighting the sensitivity of ALZpath’s pTau217 assay, 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.”
Impact of Dementia
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 democratizing 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,” says 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.”
