FDA approves new blood test for Alzheimer’s disease

The Food and Drug Administration (FDA) has granted approval for a new test for Alzheimer’s disease , marking the fourth time such a blood test has been approved in less than two years.

Roche announced Sunday that the FDA had granted approval to its Elecsys Phospho-Tau blood test for diagnosing Alzheimer’s disease. It’s the fourth such test to be granted FDA approval after the first was given the green light in May 2025 .

Developed in collaboration with Eli Lilly, the test is intended for people 55 years and older with “signs, symptoms, or complaints of cognitive decline.” The test may help physicians identify patients who should be considered for further evaluation earlier, according to Roche.

“FDA clearance of Elecsys pTau217 marks an important milestone in Alzheimer’s disease diagnosis and underscores Roche’s continued leadership in advancing innovative solutions that can help patients get answers sooner,” Dan Malarek, president and CEO of Roche Diagnostics North America, said in a company press release.

“As the first and only FDA-cleared, single-biomarker blood test supporting both rule-in and rule-out assessment of amyloid pathology, Elecsys pTau217 has the potential to transform how Alzheimer’s is assessed across primary and specialty care,” Malarek added.

Alzheimer’s disease is commonly diagnosed through cognitive testing, brain scans and by ruling out other conditions that could be causing issues with cognition and memory.

The Alzheimer’s Association celebrated the approval in a statement Monday. The organization emphasized that no single test can diagnose Alzheimer’s alone, but developments like this new approval can be incorporated with other standard evaluation methods.

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