Roche Secures CE Mark for Blood Test to Aid in Ruling Out Alzheimer’s Disease
Roche’s IVDR-certified Elecsys pTau181 blood test helps rule out Alzheimer’s early, supporting faster decisions in primary care.
Roche has received CE Mark approval for its Elecsys pTau181 test, developed in collaboration with Eli Lilly. The test measures phosphorylated Tau 181 (pTau181), a biomarker associated with amyloid pathology—one of the hallmarks of Alzheimer’s disease. Clinicians can use this test alongside other clinical data to help rule out Alzheimer’s as the cause of cognitive decline, potentially reducing the need for further diagnostic procedures in patients who test negative.
This is a minimally invasive blood test and was shown to be effective in clinical care settings such as primary care offices. The news is the latest in a series of breakthroughs in Alzheimer’s detection. This past June, The Dark Daily reported two of these stories:
- FDA Grants First-Ever Clearance of Clinical Laboratory Blood Test for Alzheimer’s Detection
- Clinical Laboratories and Drug Discovery Firms Act in Parallel against Alzheimer’s Disease
This latest development from the Swiss-based company further shows how these developments are happening on a large and international scale. This also marks the second collaboration of Roche and American-based Eli Lilly on an Alzheimer’s biomarker test. As stated by Fierce Biotech, a 2023 breakthrough was a ‘side quest’ in Eli Lilly’s ongoing crusade against Alzheimer’s disease.
Removing Barriers to Care
As stated in the press release, up to 75% of individuals who live with symptoms of Alzheimer’s disease are never diagnosed. The ones who are diagnosed wait an average of approximately three years to seek testing after they experience an onset of symptoms.
“The burden of Alzheimer’s disease on society and healthcare systems is increasing as the world’s population ages,” said Matt Sause, CEO of Roche Diagnostics.
“With Elecsys pTau181, doctors can give patients and their caregivers the clarity they need when establishing the cause of cognitive decline. By enabling an earlier and less invasive diagnosis, this test has the potential to improve patient outcomes and decrease costs for healthcare systems worldwide,” Sause noted.
First of its Kind
According to Roche, this approval is the first of its kind for a blood test that rules out Alzheimer’s disease. This international study included 787 patients. The press release also stated, “The study showed the test was able to rule out Alzheimer’s disease with a high negative predictive value (NPV) of 93.8% based on a 22.5% prevalence of amyloid positivity according to positron emission tomography (PET) scans, with 83.6% sensitivity.”
This global study’s uniqueness came from the recruitment of a diverse patient pool that was specifically designed to reflect the patients who could benefit the most from this kind of testing.
Great Strides in Alzheimer’s Research
This news follows other key developments in detection and treatment of Alzheimer’s disease. Roche also reported success with a new Alzheimer’s drug. Trontinemab, an antibody drug, performed well in clinical trials with 91% of participants showing almost complete amyloid plaque removal according to Gene Online. Roche will now go onto two large scale clinical trials for 2025 to further test the effectiveness of the drug.
With these advances in testing and treatment of Alzheimer’s disease, pathology professionals would be wise to keep on the pulse of the news. About 75% of people living with Alzheimer’s disease globally remain undiagnosed according to the Gene Online reporting––in the coming years we could see that number dramatically go down.
—Ashley Croce
