ALZpath has entered a licensing agreement with Roche for the use of the pTau217 antibody in blood tests to diagnose Alzheimer’s disease.
The agreement allows Roche to utilise ALZpath's antibody for the development and commercialisation of a blood test for Alzheimer's.
Planned to be made available on the Roche Elecsys platform, the test aims to offer a less invasive and more cost-effective diagnostic option compared to current methods.
The Roche pTau217 test has recently obtained the US Food and Drug Administration’s (FDA) breakthrough device designation.
The collaboration between Roche and pharmaceutical company Eli Lilly will facilitate the commercialisation of this blood test.
pTau217 is a biomarker intended for the detection and monitoring of Alzheimer's disease progression in blood.
Blood assays employing the ALZpath pTau217 antibody have demonstrated comparable accuracy to PET imaging or CSF testing.
However, these blood assays offer the benefits of being less invasive and more affordable.
ALZpath is looking to broaden access to its pTau217 antibody, enabling its application in various clinical and research environments.
The company is also seeking partnerships with diagnostic companies to distribute its technology to laboratories around the world.
ALZpath CEO Venkat Shastri said: “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.
“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.”
Last month, Roche obtained the FDA’s breakthrough device designation for its Tina-quant lipoprotein Lp(a) RxDx assay, a diagnostic tool for cardiovascular disease risk.
