The US Food and Drug Administration (FDA) has granted clearance for Roche’s Elecsys pTau181 test, a blood-based biomarker test for the preliminary evaluation of Alzheimer’s disease.
This test also aids in the assessment of other cognitive decline causes within the primary care environment.
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Designed for individuals who are 55 years and above experiencing cognitive decline symptoms, the minimally invasive test gauges the phosphorylated Tau (pTau) 181 protein present in the plasma of humans.
This protein is an essential Alzheimer’s biomarker, signifying the presence of both amyloid plaque as well as tau aggregate pathology.
According to Roche, the test, developed in partnership with Eli Lilly and Company, assists clinicians in identifying those at the initial stages of cognitive decline who are less likely to exhibit amyloid pathology related to Alzheimer’s.
The interpretation of the test outcomes are set to be integrated with other clinical information.
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By GlobalDataA non-interventional, multicentre clinical trial involving 312 subjects assessed the test’s performance, showing a 97.9% negative predictive value for ruling out Alzheimer’s pathology in a primary care population with early-stage, low-prevalence disease.
The Elecsys pTau181 test is fully automated and compatible with Roche’s existing range of instruments, enabling labs to adopt and scale up the testing process.
Roche Diagnostics North America CEO and president Brad Moore said: “By bringing Alzheimer’s blood-based biomarker testing into primary care, we can help patients and their clinicians get answers sooner to support them earlier in their journeys.
鈥淭his milestone reflects Roche鈥檚 leadership in diagnostics and our commitment to expanding access to innovative testing for patients and their clinicians.鈥�
Roche has also secured CE mark certification for the test in Europe. This certification recognises it as the first blood test under the In Vitro Diagnostic Regulation to assist in excluding Alzheimer’s-associated amyloid pathology.
In May 2025, the company received FDA approval for its VENTANA MET (SP44) RxDx Assay intended for evaluating the mesenchymal-epithelial transition factor (MET or c-Met) protein expression in individuals with non-squamous, non-small cell lung cancer.
