New blood test for Alzheimer's disease gets FDA approval

The Rouche test was developed in collaboration with Eli Lilly and is intended for people 55 years and older with “signs, symptoms, or complaints of cognitive decline.”

Published: August 25, 2026 7:41am

Rouche, a global healthcare company headquartered in Basel, Switzerland, announced Sunday that the U.S. Food and Drug Administration granted approval to its Elecsys Phospho-Tau blood test for diagnosing Alzheimer’s disease.

In the past two years, the FDA has approved three other such blood tests, The Hill reported

The Rouche test was developed in collaboration with Eli Lilly and is intended for people 55 years and older with “signs, symptoms, or complaints of cognitive decline.” The test may help physicians with earlier identification of patients who should be considered for further evaluation, 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.

 

 

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