Roche has received US Food and Drug Administration (FDA) clearance for its Elecsys® Phospho-Tau (217P) Plasma (pTau217) blood test, offering clinicians a minimally invasive option to support the assessment of amyloid pathology linked to Alzheimer’s disease.
The test is intended for people aged 55 and older who have signs, symptoms or concerns related to cognitive decline. According to Roche, it is the first FDA-cleared single-biomarker blood test designed to support both rule-in and rule-out assessment of amyloid pathology using the same validated clinical cutoffs across primary and specialty care.
“FDA clearance of Elecsys® pTau217 marks an important milestone in Alzheimer’s disease diagnosis and underscores Roche’s continued leadership in advancing innovative solutions that can help patients get answers sooner. As the first and only FDA-cleared, single-biomarker blood test supporting both rule-in and rule-out assessment of amyloid pathology, Elecsys® pTau217 has the potential to transform how Alzheimer’s is assessed across primary and specialty care. This kind of innovation can help bring diagnostic evaluation closer to patients and give clinicians greater confidence in determining the right step in their care” said, Dan Malarek, President and CEO of Roche Diagnostics North America
The assay provides positive, intermediate or negative results indicating the likelihood of amyloid pathology. Results are intended to be considered alongside clinical information and other diagnostic findings rather than used as a standalone diagnosis.
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The blood-based test could help address some limitations associated with traditional methods such as PET imaging and cerebrospinal fluid testing, which can be costly, invasive or less accessible.
Developed in collaboration with Eli Lilly, the test is designed to work with Roche’s existing cobas laboratory systems in the US, supporting wider implementation through established laboratory infrastructure.
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“For decades, clinicians have faced significant challenges in accurately diagnosing Alzheimer’s disease in its early stages. While PET imaging and cerebrospinal fluid biomarkers can confirm amyloid pathology in patients with cognitive impairment, these approaches may be costly, invasive and not readily accessible for many patients,” said Jared R. Brosch, M.D., Neurologist, Indiana University Health. “Advances in blood-based biomarkers have the potential to transform the diagnostic pathway by expanding access to evaluation for Alzheimer’s across a variety of care settings. As these tools become available, clinicians may be able to evaluate more patients earlier in the disease course, improving diagnostic confidence and helping patients and their families make more informed decisions at a critical time.”
