FDA clears Roche, Eli Lilly blood test for Alzheimer’s

The U.S. Food and Drug Administration has cleared a blood test developed by Roche ↗ 0.07% in collaboration with Eli Lilly ↗ 0.43% that can help detect signs of Alzheimer's disease through a simple blood draw, potentially transforming how the condition is diagnosed across the country.

A Less Invasive Path to Diagnosis

Roche announced Monday that the FDA cleared Elecsys pTau217, a biomarker blood test for individuals aged 55 and older showing signs of cognitive decline. The test measures phosphorylated tau 217 protein in the blood to determine whether amyloid plaques — a hallmark of Alzheimer's — have accumulated in the brain.biz.chosun+2

Roche described it as "the first and only FDA-cleared, single-biomarker blood test supporting both rule-in and rule-out assessment of amyloid pathology" across primary and specialty care settings. The test provides positive, intermediate, or negative result categories and is not intended as a standalone diagnostic tool.reuters+1

Until now, detecting amyloid pathology has typically required positron emission tomography scans or cerebrospinal fluid testing — procedures that are costly, invasive, and difficult to access outside specialty centers. An estimated 75% of people living with dementia remain undiagnosed, according to Roche.prnewswire+1

Broad Availability Expected

The test can run on more than 4,500 Roche cobas laboratory analyzers already installed across the United States. Labcorp ↘ 2.19% and Quest Diagnostics ↘ 1.74% have both announced plans to offer the test through their laboratory networks. Roche did not disclose the test's price.cnn+1

"For millions of families navigating the uncertainty of Alzheimer's disease, a timely diagnosis is the first and most critical step toward meaningful care," said Carole Ho, executive vice president and president of Lilly Neuroscience.prnewswire

Fourth Test Cleared in Under Two Years

The clearance marks the fourth Alzheimer's blood test approved by the FDA since Fujirebio's Lumipulse became the first to receive authorization in May 2025. It also follows the FDA's approval of C2N Diagnostics' test on August 21, which can be used in patients as young as 40.thehill+2

The Alzheimer's Association welcomed the approval. "Each FDA clearance gives clinicians another validated option to work with when evaluating patients showing signs of cognitive impairment," said Maria C. Carrillo, the organization's chief science officer. "That's real progress for a field that, for decades, had far too few tools to offer."thehill