A newly cleared blood test that measures the Alzheimer’s-associated biomarker pTau217 will give primary care physicians and specialists another less-invasive tool for evaluating patients experiencing signs of cognitive decline.
By yourNEWS Media Newsroom.
A blood test designed to help physicians identify biological signs associated with Alzheimer’s disease has received clearance from the U.S. Food and Drug Administration, expanding the diagnostic options available for adults experiencing memory or other cognitive problems.
Roche announced Aug. 24 that the FDA had cleared its Elecsys pTau-217 test for use in people ages 55 and older who have signs of cognitive decline or who have reported concerns about declining cognitive abilities.
The test measures plasma phosphorylated tau 217, commonly known as pTau217, a biomarker associated with Alzheimer’s disease. Unlike diagnostic procedures that require collection of cerebrospinal fluid, the new test requires an ordinary blood draw and can be ordered by both primary care physicians and specialists.
“Elecsys pTau217 has the potential to transform how Alzheimer’s is assessed across primary and specialty care,” Dan Malarek, president and CEO of Roche Diagnostics North America, said in a statement.
“This kind of innovation can help bring diagnostic evaluation closer to patients and give clinicians greater confidence in determining the right step in their care.”
Research has linked elevated concentrations of pTau217 with a greater likelihood that a person will progress to cognitive impairment. A study conducted from 2004 through 2025 and published in JAMA found that people with higher levels of the biomarker faced an increased risk of such progression.
The Roche test joins a growing group of blood-based products intended to assist clinicians evaluating patients for Alzheimer’s disease.
The FDA began approving other Alzheimer’s blood tests in 2025, including a test developed by Fujirebio Diagnostics that measures pTau217 along with another protein. Roche said Elecsys pTau-217 differs because it is the first such test to assess a single biomarker.
The arrival of blood-based testing could simplify one part of the evaluation process for a disease that progressively damages memory, thinking and a person’s ability to function independently.
Alzheimer’s is a degenerative brain disorder in which cognitive abilities worsen over time. As the disease advances, patients can eventually lose the ability to carry out basic activities, including eating and walking. Many patients begin noticing symptoms such as memory problems when they are in their 60s or 70s.
Organizations focused on Alzheimer’s research and patient care have supported the introduction of blood tests because they offer a less invasive alternative to procedures involving cerebrospinal fluid.
Maria C. Carrillo, chief science officer and medical affairs lead for the Alzheimer’s Association, said the addition of another FDA-cleared test expands the choices available to doctors assessing patients with cognitive symptoms.
“Each FDA clearance gives clinicians another validated option to work with when evaluating patients showing signs of cognitive impairment,” Carrillo said in a statement.
“That’s real progress for a field that, for decades, had far too few tools to offer.”
Lilly Neuroscience also participated in developing the test.
Dr. Carole Ho, executive vice president and president of Lilly Neuroscience, emphasized the importance of identifying the disease in a timely manner for patients and their families.
“For millions of families navigating the uncertainty of Alzheimer’s disease, a timely diagnosis is the first and most critical step toward meaningful care,” Ho said in a statement.
The test is also expected to be broadly accessible through two of the nation’s major laboratory providers.
Labcorp and Quest Diagnostics said they will offer Elecsys pTau-217. After a physician orders the test, a patient can have blood collected at a doctor’s office, a Labcorp service center or a Quest Diagnostics location.
The FDA clearance gives physicians another tool for evaluating people 55 and older who are already experiencing or reporting cognitive decline, while providing patients with an option that can be performed through a routine blood draw rather than more invasive diagnostic testing.
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