Roche collects more data to support blood tests for diagnosing Alzheimer’s disease

Roche put forward new data on two of its upcoming, non-invasive blood tests designed to help rule out a diagnosis of Alzheimer’s disease.

The two plasma-based, in vitro tests scan for specific proteins linked to changes in the brain driven by the neurodegenerative condition, as a way to help distinguish patients within the early stages of Alzheimer’s among those starting to show symptoms of cognitive decline.

Presented at the Clinical Trials in Alzheimer’s Disease congress, being held in Madrid, Spain, Roche’s diagnostics unit showed that a negative result from one test—its Elecsys amyloid plasma panel, which checks blood levels for a combination of phosphorylated Tau-181 and apolipoprotein E4—could be counted on to help identify patients who were unlikely to have the amyloid plaque deposits associated with Alzheimer’s.

In clinical practice, this comparatively simple blood test could help healthcare providers decide whether or not to pursue further exams with PET brain scans or drawing cerebrospinal fluid samples. A prospective study of 492 patients demonstrated the amyloid panel’s negative predictive value of 96.2%, according to the company, with 91.0% sensitivity and 69.8% specificity.

“The data from this large-scale study in cognitively impaired individuals suggests that a fast and simple blood test could reliably rule out amyloid pathology, offering much-needed reassurance to patients and their families,” Roche Diagnostics CEO Matt Sause said in a statement.

“Alzheimer’s disease is one of the most challenging health issues of our time, and its impact on society is growing as the world’s population ages,” Sause added. “For many people, getting a clear and timely diagnosis remains challenging. This test could help patients to receive the right care at the earliest opportunity.”

The company described the trial as the first of its kind for a diagnostic of this type, and that its participant population aimed to closely reflect who would be seen in real-world settings, adding that the amyloid panel’s performance was “only minimally impacted” by patients’ age, sex, body mass index or kidney function. The test previously received a breakthrough designation from the FDA in 2023.

Meanwhile, a second Elecsys diagnostic focusing on a different tau protein—this one pTau217—delivered data on a head-to-head comparison with a plasma assay targeting the same biomarker developed for Fujirebio’s Lumipulse system. Both tests are currently only available for research use only.

In a CTAD poster presentation, Roche said the blinded study found that both the Elecsys and Lumipulse automated assays showed strong discrimination of amyloid-negative and amyloid-positive samples, though the Elecsys test had a narrower range of samples return as indeterminate results.