FDA Clears Roche and Lilly Alzheimer’s Blood Test to Help Assess Brain Amyloid

Indianapolis, Indiana - Roche has received U.S. Food and Drug Administration clearance for Elecsys Phospho-Tau (217P) Plasma, a blood test developed in collaboration with Eli Lilly and Company to help assess Alzheimer’s disease-related brain changes.

The test, also known as Elecsys pTau217, is intended for people 55 and older who have signs, symptoms or complaints of cognitive decline. It measures phosphorylated tau 217, or pTau217, a blood-based biomarker linked to amyloid pathology associated with Alzheimer’s disease.

Roche said the test is the first FDA-cleared, single-biomarker blood test designed to support both rule-in and rule-out assessment of amyloid pathology across primary and specialty care settings.

The test provides three result categories: positive, intermediate or negative. A positive result indicates a higher likelihood of amyloid pathology, while a negative result suggests a lower likelihood. An intermediate result means additional evaluation may be needed.

Importantly, Roche said the test is not intended to be used alone to diagnose Alzheimer’s disease. Results must be interpreted along with clinical information and other diagnostic findings as part of a broader medical evaluation.

The clearance could make Alzheimer’s assessment more accessible because the test uses a routine blood draw and is designed to run on Roche’s existing cobas laboratory systems. Roche said more than 4,500 cobas instruments are already installed in U.S. clinical laboratories.

Alzheimer’s disease diagnosis has traditionally relied on clinical evaluation, cognitive testing and, in some cases, more specialized tools such as amyloid PET scans or cerebrospinal fluid testing. Those options can be expensive, less available or more invasive than blood-based testing.

The Alzheimer’s Association called the clearance another step toward more accessible diagnosis, noting that blood-based biomarkers are becoming an increasingly important part of Alzheimer’s care and research.

The development comes as new Alzheimer’s treatments have increased the importance of identifying patients earlier and more accurately. Earlier evaluation can help patients, families and physicians better understand symptoms, plan care and consider appropriate treatment options.

For Asian American families and caregivers, including those in Arizona, the approval highlights the growing role of early detection and medical access in aging communities. Families concerned about memory loss or cognitive changes should speak with a qualified healthcare professional rather than relying on any single test result.