FDA clears first blood test for both rule-in and rule-out Alzheimer’s assessment

Roche has announced that the U.S. Food and Drug Administration (FDA) has cleared the 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’s disease in individuals 55 years and older with signs, symptoms or complaints of cognitive decline¹.

Developed in collaboration with Eli Lilly and Company, Elecsys^® pTau217 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. 

The test is designed for use across Roche’s cobas^® laboratory instruments in the United States, enabling broad access through existing laboratory infrastructure.

Supporting clinical decision-making

Following FDA clearance, Elecsys^® pTau217 may help healthcare providers and health systems:

• Support clinical decision-making across primary and speciality care settings through a single-biomarker blood test that provides positive, intermediate or negative amyloid pathology results to aid clinical assessment of amyloid pathology. 
• Help identify appropriate next steps by distinguishing patients with a high or low likelihood of amyloid pathology and those who should be considered for further testing. 
• Support a more efficient diagnostic pathway by providing a minimally invasive blood-based option that may help clinicians determine when additional evaluation, including PET imaging or CSF testing, is appropriate. 

Dan Malarek, President and CEO of Roche Diagnostics North America, said, “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.”

Carole Ho, M.D., Executive Vice President and President, Lilly Neuroscience, added, “For millions of families navigating the uncertainty of Alzheimer’s disease, a timely diagnosis is the first and most critical step toward meaningful care. 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.”

References

1. Clifford Jack Jr, Dunn B, Snyder H., et al. Revised criteria for diagnosis and staging of Alzheimer’s disease: Alzheimer’s Association workgroup. Alzheimer’s & Dementia. 2024;1–27. doi:10.1002/alz.13859.

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