FDA Clears Roche’s Elecsys pTau181 Test for Ruling Out Alzheimer-Related related Amyloid Pathology

According to a new announcement, the FDA has given clearance to Roche’s Elecsys ptau181 test, marking it the first blood-based biomarker test available for use in primary care settings to assist in Alzheimer disease (AD) assessment and diagnosis. Through this minimally invasive test, clinicians may better identify patients in early stages of cognitive decline who are unlikely to have AD-related amyloid pathology.¹

The Elecsys pTau 181 test, which gained European CE mark earlier this year, is intended for patients aged 55 and older presenting with signs, symptoms, or complaints of cognitive decline. To date, it remains the first and only In Vitro Diagnostic Regulation (IVDR)-certified blood test to help rule out AD-associated amyloid pathology.

"By bringing Alzheimer's blood-based biomarker testing into primary care, we can help patients and their clinicians get answers sooner to support them earlier in their journeys," Brad Moore, president and chief executive officer at Roche Diagnostics, said in a statement.¹ "This milestone reflects Roche’s leadership in diagnostics and our commitment to expanding access to innovative testing for patients and their clinicians."

Elecsys pTau181 test has been evaluated in several settings, with one multicenter, non-interventional trial leading the way. In this study of 312 participants, the diagnostic tool helped rule out AD pathology with a 97.9% negative predictive value (NPV).

With FDA clearance, the hope is that this Elecsys pTau181 test may help early assessment of patients with cognitive complaints, improve referral quality by guiding physicians decisions on patient referrals, and help preserve neurologists’ resources for patients with the greatest need. In addition, there is potential for less use of more invasive and costly procedures such as PET and cerebrospinal fluid testing.

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The FDA’s approval of the test comes at a critical time, as the need for reliable Alzheimer disease screening and diagnostic tools continues to grow. The emergence of anti-amyloid therapies—proven to be most effective when initiated in the earliest stages of disease—has fundamentally shifted how clinicians approach Alzheimer treatment. In recent years, two FDA-approved agents in this class, lecanemab (Leqembi; Eisai) and donanemab (Kisunla; Eli Lilly), received approval in 2023 and 2024, respectively, ushering in a new era of disease-modifying care.

The test gained CE mark earlier this year based on data from a prospective, multicenter study, which included 787 patients across the U.S., Europe, and Australia. All told, the test was able to rule out AD with an NPV of 93.8% based on a 22.5% prevalence of amyloid positivity according to PET scans, with 83.6% sensitivity. In this diagnostic registrational study of patients aged 55-80 years old, the rule out performance was only minimally impacted by the patients’ age, gender, body mass index, or impaired kidney function.²

The Elecsys pTau181 test is part of Roche’s larger Elecsys Amyloid Plasma Panel, a minimally invasive blood test that measures pTau181 protein and apolipoprotein (APOE) e4 in plasma. The panel, which received FDA breakthrough device designation in July 2023, was shown to have an NPV of 96.2% based on a 22.5% prevalence of amyloid positivity according to PET scans, with 91.0% sensitivity, in a previously conducted prospective trial.³

REFERENCES
1. Roche’s Elecsys® pTau181 becomes the only FDA-cleared blood test for use in primary care to rule out Alzheimer’s-related amyloid pathology. News release. Roche. October 13, 2025. Accessed October 14, 2025. https://diagnostics.roche.com/us/en/news-listing/2025/fda-cleared-ptau181-alzheimers-blood-test.html
2. Roche receives CE Mark for minimally invasive blood test to help rule out Alzheimer’s disease. July 23, 2025. Accessed October 14, 2025. https://www.globenewswire.com/news-release/2025/07/23/3119980/0/en/Roche-receives-CE-Mark-for-minimally-invasive-blood-test-to-help-rule-out-Alzheimer-s-disease.html
3. Roche presents new data at CTAD, demonstrating its growing momentum in diagnostics for Alzheimer’s disease. News release. Roche. October 30, 2024. Accessed October 14, 2025. https://www.roche.com/media/releases/med-cor-2024-10-31b