Roche has entered into a strategic licence agreement with ALZpath, using its tau phosphorylated at amino acid 217 (pTau217) antibody, to develop and commercialise a diagnostic blood test for Alzheimer’s disease (AD) in its earliest stages.
The diagnostic test could potentially be used to screen and help avert the clinical onset of the neurological condition when effective prevention therapies become available.
AD is a progressive form of dementia that slowly destroys an individual’s memory and thinking skills.
As part of the agreement, Roche will leverage ALZpath’s pTau217 antibody to develop and commercialise an AD diagnostic blood test to be offered on the Roche Elecsys platform.
Plasma levels of pTau217 are recognised as a sensitive marker of AD, providing diagnostic and prognostic information in the neurodegenerative disease.
Venkat Shastri, chief executive officer, ALZpath, said that the agreement “represents a key step towards [the] global availability of testing as treatments emerge”.
He continued: “The broad availability of an easy-to-use diagnostic test can profoundly impact AD research, therapeutic clinical trials and clinical care.”
In April, the Elecsys pTau217 blood test, developed and commercialised in collaboration with Eli Lilly and announced in March 2023, received Breakthrough Device Designation from the US Food and Drug Administration for the earlier diagnosis of AD.
In previous studies using ALZpath’s pTau217 antibody, blood-based assays have demonstrated the same accuracy and reliability as PET imaging or cerebral spinal fluid testing, which are more expensive and invasive processes, in a more affordable, convenient and less invasive way.
In January, a Swedish study published in JAMA Neurology determined that ALZpath’s test was just as successful at detecting levels of pTau217 in the blood, reflecting levels of amyloid and tau proteins, as standard lumbar punctures when detecting AD.
Sterling Johnson, advisor to ALZpath, said: “Incorporating… the ALZpath pTau217 antibody into… the Roche Elecys could help transform AD research, accelerate the evaluation of promising interventions to treat and prevent the disease, and improve the assessment and care of people with memory problems.”
The innovative diagnostic tool and solutions company for AD and dementia has also confirmed that it aims to pursue further strategic partnerships with global diagnostic leaders to make its technology available in laboratories globally as new treatments emerge.