Roche Alzheimer's Blood Tests Gain FDA and CE Approvals Amid Medicare Coverage Gap
Roche's Elecsys pTau181 test received FDA clearance for primary care use, and its Elecsys ApoE4 test earned CE Mark approval. Despite these advances, Medicare does not cover Alzheimer's blood biomarker screenings before symptoms appear, prompting the bipartisan ASAP Act.
The U.S. Food and Drug Administration has cleared Roche's Elecsys pTau181 blood test for use in primary care settings for the initial assessment of Alzheimer's disease and other causes of cognitive decline, while the company also received CE Mark approval for its Elecsys Apolipoprotein E4 biomarker test. The Elecsys pTau181 test is intended for consumers ages 55 and older presenting with signs, symptoms, or complaints of cognitive decline, and it measures phosphorylated Tau (pTau) 181 protein in human plasma, a key biomarker for Alzheimer's pathology. Developed in collaboration with Eli Lilly and Company, the test is a blood-based biomarker test used in the initial assessment for Alzheimer's disease and other causes of cognitive decline.
The Elecsys ApoE4 test is the first in-vitro diagnostic immunoassay to identify the presence of the ApoE4 gene variant in the bloodstream. The ApoE4 gene variant is associated with an increased risk of late-onset Alzheimer's disease and is present in around 40-60% of patients with the condition. In a clinical evaluation, results from the Elecsys ApoE4 test were compared with APOE4 genotyping performed using Sanger sequencing; the assay showed 100% concordance between ApoE4 protein detection and genetic APOE4 status, correctly identifying all genetic carriers and non-carriers.
Despite these approvals, Medicare does not cover blood-based biomarker screenings for Alzheimer's before symptoms appear. Medicare pays for biomarker blood tests only after a patient is already showing outward symptoms of cognitive decline; screening a patient before symptoms appear is not covered. This leaves millions of Americans undiagnosed or forced to wait until more serious symptoms appear. Bipartisan legislation introduced in both chambers of Congress — the Alzheimer's Screening and Prevention Act, or ASAP Act — would create a Medicare coverage pathway for FDA-approved blood biomarker screening tests, speeding up access to earlier diagnosis for the more than 7 million people in the U.S. living with Alzheimer's. As many as half of those with the disease or at risk for it remain undiagnosed, according to University of Michigan researchers.
The FDA approved two blood-based biomarker tests in 2025 for people 55 and older who show signs or symptoms of cognitive impairment. One, designed for primary care settings, can rule out Alzheimer's in those who test negative with a 90% negative predictive value. A second, used in specialty settings, can help confirm a diagnosis, reducing the need for spinal taps or PET scans that cost upward of $10,000. Wider use of blood biomarker tests could help fill geographic gaps in care: in wide stretches of the country, including the Dakotas, Montana, Wyoming and Idaho, PET scans are not available, and even in major metropolitan areas, patients routinely wait 12 to 18 months to see a neurologist.