FDA Clears First and Only Single-Biomarker Blood Test for Alzheimer Disease Assessment

The US Food and Drug Administration (FDA) has cleared Roche’s Elecsys Phospho-Tau (217P) Plasma (pTau217) blood test, providing clinicians across primary and specialty care with a single blood-based option to aid in identifying amyloid pathology associated with Alzheimer disease in patients aged 55 years and older with signs, symptoms, or complaints of cognitive decline.^1,2 

Elecsys pTau217 was developed in collaboration with Eli Lilly and Company, and is the first and only FDA-cleared, single-biomarker blood test that supports both rule-in and rule-out assessment of amyloid pathology using the same validated clinical cutoffs across primary and specialty care settings.

"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," said Dan Malarek, the president and chief executive officer of Roche Diagnostics North America. "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.”

How the Elecsys pTau217 Test Works

The assay provides positive, intermediate, and negative result categories to support assessment of the likelihood of amyloid pathology. Clinicians can interpret results in conjunction with clinical information and other relevant findings as part of the Alzheimer disease diagnostic pathway.

The test is designed for use across Roche's more than 4500 cobas laboratory instruments in the United States, enabling broad access through existing laboratory infrastructure.

“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,” concluded Malarek.

Addressing Barriers

Dementia often goes undiagnosed and those who are diagnosed may experience years of uncertainty after symptoms first appear. The typical approaches used to assess amyloid pathology, such as positron emission tomography (PET) imaging and cerebrospinal fluid (CSF) testing, can be costly, invasive, and difficult to access outside.

The Elecsys pTau217 blood test helps address these barriers by:

• Being a minimally invasive blood-based option that can be incorporated into existing clinical and laboratory workflows
• Helping clinicians assess the likelihood of amyloid pathology earlier in the disease and diagnostic pathway
• Assisting in the identification of patients who should be considered for additional evaluation or specialist referral

"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, MD, a neurologist at 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."

Next Steps

Following FDA clearance, the Elecsys pTau217 may help health care providers and health systems by simplifying laboratory implementation and using a single biomarker/set of validated clinical cutoffs to support both rule-in and rule-out assessment of amyloid pathology.

"For millions of families navigating the uncertainty of Alzheimer's disease, a timely diagnosis is the first and most critical step toward meaningful care," said Carole Ho, MD, the executive vice president and president of Lilly Neuroscience. "Lilly's collaboration with Roche on Elecsys pTau217 was driven by a shared commitment to bringing one blood test into both primary care, where most patients with cognitive complaints are first seen, and specialty care, helping close the gap between symptoms and answers."

However, Elecsys pTau217 is not intended to be used as a stand-alone test. Results should be interpreted in conjunction with other diagnostic tools and clinical information. The safety and effectiveness of the assay have not been established for predicting development of dementia or other neurologic conditions or for monitoring the effect of therapeutic products.

References

1. Roche receives FDA clearance for Elecsys® pTau217, advancing Alzheimer's disease assessment across primary and specialty care. News release. August 24, 2026. Accessed August 24, 2026. https://diagnostics.roche.com/us/en/news-listing/2026/fda-elecsys-ptau217-alzheimers-blood-test.html

2. Clifford Jack Jr, Dunn B, Snyder H, et al. Revised criteria for diagnosis and staging of Alzheimer's disease: Alzheimer's Association workgroup. Alzheimers Dement. 2024;20(8):5143-5169.