Roche has signed a licensing agreement with Alzheimer’s disease (AD)-focused diagnostic company ALZpath to use the latter’s pTau217 antibody to develop and distribute a blood test for diagnosing AD.

The blood test will be provided on Roche’s Elecsys platform to identify amyloid pathology, a key feature of AD.

Roche had received breakthrough device designation for its pTau217 test from the US Food and Drug Administration (FDA) in April 2024.

The test will be brought to market through a collaborative effort between Roche and Eli Lilly.

According to ALZpath, the pTau217 biomarker is pivotal in identifying the presence and advancement of Alzheimer’s disease in blood.

The integration of ALZpath’s pTau217 antibody in blood-based assays has demonstrated the same precision and dependability when compared to more costlier and invasive methods such as PET imaging or cerebral spinal fluid (CSF) testing.

However, the blood tests are more affordable and less invasive, providing a convenient diagnostic option, the company added.

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.

“The broad availability of an easy-to-use diagnostic test can profoundly impact Alzheimer’s disease research, therapeutic clinical trials, and clinical care.”

ALZpath is expanding access to its proprietary pTau217 antibody, which is adaptable for various clinical and research environments.  

The company is forging collaborations with global diagnostic entities, aiming to extend its technology as potential treatments for AD to laboratories on a global scale.

The antibody is used by researchers, clinicians, and industry partners to expedite the development of new treatments and enhance patient care.

In February 2024, ALZpath and Alamar Biosciences signed a supply agreement for pTau217 antibody to advance Alzheimer’s disease research.