Early Detection of Alzheimer's with a Drop of Blood... Consecutive FDA Approvals in the U.S.

Roche and Eli Lilly's Jointly Developed 'Tau' Test
FDA Grants Approval; Fourth Test Cleared in Two Years
More than 4,500 Devices in Use—Major Advantage in Accessibility

In the United States, simple blood tests for the early detection of Alzheimer's disease are increasingly clearing regulatory hurdles. Since the first approval in May of last year, the fourth Alzheimer's blood test has already received regulatory approval, raising expectations that patients may soon face less of a burden.

According to U.S. political outlet The Hill and other foreign media on August 24 (local time), the U.S. Food and Drug Administration (FDA) has approved the 'Elecsys Phospho-Tau 217 (pTau217)' blood test co-developed by global pharmaceutical companies Roche and Eli Lilly. This test measures phosphorylated tau 217 in the blood of patients aged 55 or older with cognitive impairment, helping doctors assess whether Alzheimer's-related amyloid pathology may be present in the brain.

Swiss pharmaceutical company Roche. Photo by Reuters Yonhap News.

According to Roche, this test is the first and only FDA-approved blood test that helps confirm or rule out amyloid pathology using a single biomarker. However, it is not a standalone diagnostic for Alzheimer's; results must be interpreted alongside other clinical information.

The greatest strength of this test is its accessibility. It can be used on more than 4,500 Roche testing devices already installed across the United States, and major diagnostic companies LabCorp and Quest Diagnostics also plan to offer the service through their laboratory networks. However, Roche has not disclosed the price of the test.

This marks the fourth time since May of last year that an Alzheimer's blood test has received FDA approval in the United States. Previously, Fujirebio’s ‘Lumipulse’ was authorized as the first blood-based test to aid in Alzheimer’s diagnosis.

Traditionally, checking for amyloid buildup in the brain associated with Alzheimer’s has required either positron emission tomography (PET) or cerebrospinal fluid analysis. However, PET has limitations due to costs and equipment accessibility. Cerebrospinal fluid tests also caused considerable discomfort, as they involve inserting a needle into the lower back to collect fluid.

With the advent of new treatments that can slow the progression of Alzheimer’s, there is an increasing need to identify early-stage patients—those who stand to benefit from these therapies—more quickly. As a result, pharmaceutical and diagnostic companies are accelerating the race to develop more convenient blood-based tests.

Maria Carrillo, Chief Science Officer at the Alzheimer's Association, said, “Each time the FDA approves a new test, medical professionals gain a validated option for assessing patients who show signs of cognitive impairment. This represents genuine progress in a field where usable tools have been extremely limited for decades.”

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