By Zachary Stieber
Contributing Writer
Federal regulators have cleared a blood test aimed at detecting signs of Alzheimer’s disease.
The Food and Drug Administration cleared a blood test known as Elecsys pTau-217 for people aged at least 55 who have shown signs of, or have been complaining of, cognitive decline, Roche announced on Monday.
The test, which can be used by primary care doctors and specialists, detects a biomarker called plasma phosphorylated tau 217. In a study that ran from 2004 to 2025 and was published in JAMA, researchers found that higher levels of the biomarker were associated with an increased risk of progression to cognitive impairment.
The FDA has previously approved several other tests for Alzheimer’s, beginning in 2025 with a test from Fujirebio Diagnostics that measures both pTau217 and another protein. Roche said its test is the first to measure a single biomarker.
“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.”
Alzheimer’s is a brain disorder that destroys a person’s memory and thinking skills over time. People with the disease gradually become unable to perform tasks such as eating and walking. Many people begin experiencing symptoms such as memory difficulties between the ages of 60 and 70.
The Alzheimer’s Association and other groups have welcomed the tests as a less invasive option than other methods, such as testing of cerebrospinal fluid.
“Each FDA clearance gives clinicians another validated option to work with when evaluating patients showing signs of cognitive impairment,” Maria C. Carrillo, the association’s chief science officer and medical affairs lead, said in a statement.
“That’s real progress for a field that, for decades, had far too few tools to offer.”
Dr. Carole Ho, executive vice president and president of Lilly Neuroscience, which helped develop the test, said in a statement that “for millions of families navigating the uncertainty of Alzheimer’s disease, a timely diagnosis is the first and most critical step toward meaningful care.”
Labcorp and Quest Diagnostics said they will carry the new test.
Once ordered by a doctor, patients can have their blood drawn for the test in a doctor’s office, a Labcorp service center, or a Quest center.
