Roche Gains FDA Clearance for Alzheimer’s Blood Test
Roche has received US Food and Drug Administration (FDA) clearance for Elecsys pTau217, a blood-based test designed to help identify amyloid pathology associated with Alzheimer’s disease.
Developed in collaboration with Eli Lilly and Company, the test is intended for people aged 55 and older who have signs, symptoms or concerns related to cognitive decline.
Roche describes it as the first FDA-cleared single-biomarker blood test designed to support both rule-in and rule-out assessment of amyloid pathology using the same validated clinical cut-offs.
Elecsys pTau217 provides positive, intermediate or negative results to help clinicians assess the likelihood of amyloid pathology.
The results are intended to be considered alongside clinical information and other diagnostic findings rather than used as a stand-alone diagnosis.
The blood test offers a less invasive alternative to established methods such as positron emission tomography (PET) imaging and cerebrospinal fluid testing, which can be costly, invasive or less accessible in some settings.
The assay is designed to run on Roche’s existing cobas laboratory systems, with more than 4,500 instruments installed across US clinical laboratories.
This could support wider adoption without requiring additional laboratory equipment.
The FDA clearance marks a further step in expanding blood-based Alzheimer’s testing across primary and specialist care.
Roche plans to use the technology to support earlier assessment, improve referral decisions and help streamline the diagnostic pathway for cognitive decline.
