The U.S. Food and Drug Administration has approved a new tab blood test for Roche (ROPC.S) and Eli Lilly’s (LLY.N) to assist detect indications of Alzheimer’s disease in those with cognitive decline who are 55 years of age or older.
According to Roche on Monday, the test, Elecsys pTau217, is a biomarker blood test that can assist medical professionals in determining which people are likely or unlikely to have brain abnormalities associated with Alzheimer’s.
The test was approved in Europe in May before receiving FDA permission.
The test may be performed on the more than 4,500 Roche laboratory analyzers that are currently in use throughout the US, which the company claimed could aid in expanding access.
Separately, Quest Diagnostics (DGX.N), opens new tab, and Labcorp (LH.N), opens new tab stated that they intend to provide the test through their laboratory networks, possibly increasing access throughout the United States.
The cost of the test was not disclosed by Roche. The current techniques for identifying amyloid, a protein associated with the illness, mostly depend on cerebrospinal fluid tests or positron emission tomography (PET) scans, which can be costly, intrusive, and less accessible.
The FDA approval coincides with a race by pharmaceutical and diagnostic firms to create more straightforward Alzheimer’s disease tests in response to the increasing need for early identification and treatment.
In 2025, Fujirebio’s Lumipulse became the first blood test approved by the FDA to help diagnose Alzheimer’s disease.
According to Roche, Elecsys pTau217 is not meant to be used as a stand-alone diagnostic test and results should be considered in conjunction with other clinical data.
