ALZpath licenses Alzheimer’s diagnosis tech to Roche

Diagnostics giant Roche is putting its weight behind a biomarker for Alzheimer’s disease developed by ALZpath.

The Swiss group has taken a license to use an antibody developed by ALZpath against a form of phosphorylated tau protein – pTau217 – for the development and commercialisation of a blood test for Alzheimer’s.

Studies have suggested that detecting pTau217 in blood samples may be able to identify people at elevated risk for developing Alzheimer’s years before they develop any cognitive symptoms. It also has the potential to distinguish Alzheimer’s from other neurodegenerative disorders, and was recently awarded breakthrough status by the FDA.

At the moment, AD is typically diagnosed with the help of time-consuming and expensive PET brain scans or invasive cerebrospinal fluid (CSF) analysis carried out by lumbar puncture, coupled with cognitive testing.

All of these tests can be hard to access for patients, which contributes to the current situation where almost four in 10 people with dementia do not have a diagnosis, according to the Alzheimer’s Society.

Blood assays employing the pTau217 antibody have demonstrated comparable accuracy to PET imaging or CSF testing, according to ALZpath, but offer “the affordability and convenience of a simple, less invasive blood test.”

Roche – which has a collaboration with Eli Lilly on the development and commercialisation of blood tests for Alzheimer’s – aims to develop a test for pTau217 for its widely-used Elecsys analyser platform.

An FDA advisory committee has just unanimously voted in favour of Lilly’s anti-amyloid Alzheimer’s therapy donanemab, setting up a possible approval later this year.

In time, an effective blood test will be invaluable for selecting patients who may benefit from therapies like donanemab and Eisai and Biogen’s already-approved Leqembi (lecanemab), as well as to recruit patients into clinical trials of new drug candidates.

Incorporating pTau217 into 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,” said ALZpath advisor Sterling Johnson.

“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,” he added.

The company already markets a version of the test under the ALZpath Dx brand in the US, which has been adopted for use by various clinical testing laboratories, including Neurocode USA and Alamar Biosciences.