FDA Clears Blood Test to Detect Alzheimer’s in Primary and Specialty Care
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The FDA cleared the Elecsys pTau217 blood test to identify amyloid-beta pathology associated with Alzheimer’s disease in people ages 55 and older with symptoms of cognitive decline, Roche announced Monday.
The test, developed with partner Eli Lilly, supports both rule-in and rule-out assessments of amyloid pathology using the same validated clinical cutoffs in primary and specialty care settings, the company said.
“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,” Carole Ho, MD, president of Lilly Neuroscience, said in a statement.
The assay measures plasma phosphorylated tau 217, an indicator of amyloid burden. It simplifies laboratory testing by using one biomarker and one set of validated clinical cutoffs, Roche said. Evaluated in people 55 and older with signs, symptoms, or complaints of cognitive decline, Elecsys pTau217 demonstrated high agreement with amyloid PET imaging, the company added.
Elecsys pTau217 is not intended to be used as a standalone test. “Results should be interpreted in conjunction with other diagnostic tools and clinical information,” Roche stated. “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.”
The announcement comes on the heels of FDA clearance last week for the PrecivityAD2 blood test from C2N Diagnostics, which uses mass spectrometry to quantify amyloid and tau peptides and rule in or rule out Alzheimer’s disease in people with symptoms.
In 2025, the FDA cleared two other diagnostic blood tests for Alzheimer’s disease: Fujirebio’s Lumipulse test to help clinicians identify Alzheimer’s in people with signs and symptoms, and Roche’s Elecsys pTau181 assay to rule out Alzheimer’s disease in primary care.
Lab-developed tests not approved by the FDA are also on the market. Last year, the Alzheimer’s Association issued guidance outlining sensitivity and specificity parameters for Alzheimer’s blood tests to either triage or diagnose people with cognitive impairment.
Both LabCorp and Quest Diagnostics said Monday that they will offer the Elecsys pTau217 test through their networks.
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