
The US Food and Drug Administration’s (FDA) recent clearance of Roche’s blood-based Alzheimer’s disease test will boost therapeutic intervention options for the disease and clinical trial enrolment, an expert has said.
Developed in collaboration with Eli Lilly, Roche’s Elecsys pTau181 is designed for the preliminary evaluation of Alzheimer’s disease. Cleared by the FDA earlier this month, the test is intended for the evaluation of individuals aged 55 years and above who are experiencing symptoms of cognitive decline.
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Elecsys gauges the levels of phosphorylated Tau (pTau) 181 protein present in an individual’s plasma – one of the key biomarkers for Alzheimer’s disease pathology.
The test’s FDA clearance was supported by a clinical study that included 312 participants. Results demonstrated that in an early disease-stage, low-prevalence population, the test could rule out Alzheimer’s disease pathology with a 97.9% negative predictive value (NPV).
While Roche’s test is not the first to gain FDA clearance for Alzheimer’s disease evaluation (others include C2N’s PrecivityAD), it is the first approved for use in primary care settings.
This availability will open up diagnostic testing to vast numbers of people in need of “good early assessment” of their cognitive function, Gary Zammit, CEO of blood testing provider Clinilabs, told Medical Device Network.

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By GlobalData“Up to now, people would need to have imaging, or have cerebrospinal fluid (CSF) samples taken, which is a particularly invasive procedure. With this simple blood test, it makes the procedure much more convenient, accessible, and tolerable for patients,” Zammit said.
Zammit goes on to highlight Roche’s test’s value in ruling out whether an individual is likely to have Alzheimer’s disease – a factor that will likely benefit Alzheimer’s disease clinical trials, which research indicates have a 98% failure rate.
“One of the reasons that drugs fail is because it can be difficult to confirm the diagnosis of Alzheimer’s disease,” Zammit explained.
“With a test like Elecsys available, researchers can now more confidently exclude certain people from clinical trials by doing the test in advance; then if it’s not Alzheimer’s disease, they wouldn’t be put into the trial for Alzheimer’s disease.
“Therefore, the availability of Elecsys will help to better define the patient populations that we’re testing, which should in turn help to reduce the failure rate in Alzheimer’s disease clinical trials,” Zammit noted.
In addition, with a tool that could help reduce trial failure rates, Zammit anticipates that Roche’s test could affect the broader R&D space in Alzheimer’s disease.
He said: “Some biotech firms and pharmaceutical companies shy away from developing these drugs because they know of the high failure rate. If it’s a biotech firm, they have to find investors that will invest in the idea and put their money at risk, yet with such a high failure rate, it can be difficult to do that.
“If this test can be used to select patients for participation in clinical trials, and by virtue of that, help reduce trial failure rates, it might open up the field and allow more companies to develop newer drugs, new mechanisms of action, and to generally take more risks in the drug development process”.