Roche has unveiled fresh data supporting two of its innovative blood tests, designed to assist in diagnosing Alzheimer’s disease with a non-invasive approach. The tests aim to help rule out Alzheimer’s in patients showing early signs of cognitive decline by detecting proteins linked to the disease’s progression.
Presented at the Clinical Trials in Alzheimer’s Disease (CTAD) conference in Madrid, the data highlight Roche’s Elecsys amyloid plasma panel. This blood test screens for levels of phosphorylated Tau-181 and apolipoprotein E4—proteins linked to Alzheimer’s-related brain changes. A negative result from this test can help identify individuals unlikely to have amyloid plaque, a key marker of Alzheimer’s.
The panel’s real-world utility could significantly ease the diagnostic process, reducing the need for more invasive exams like PET scans or spinal fluid sampling. Roche reports that in a study involving 492 participants, the amyloid plasma panel demonstrated a high negative predictive value of 96.2%, with a sensitivity of 91.0% and specificity of 69.8%.
“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. “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.”
According to Roche, this large-scale trial, which closely simulates a real-world patient demographic, marks a breakthrough for such diagnostics, showing that the test’s accuracy is only minimally affected by factors like age, gender, BMI, or kidney health. The test received a breakthrough designation from the FDA in 2023.
Additionally, Roche presented data on a second blood test targeting the pTau217 protein, another biomarker associated with Alzheimer’s. A head-to-head study with Fujirebio’s Lumipulse system showed that both tests effectively distinguished between amyloid-positive and amyloid-negative samples, with the Elecsys assay yielding fewer indeterminate results.
Currently available only for research purposes, these blood tests represent a significant step forward in Alzheimer’s diagnostics, promising simpler and faster options for early detection in the future.
