FDA Clears Roche, Lilly Alzheimer’s Blood Test for Patients 55 and Older
Updated
Updated · Forbes · Aug 24
FDA Clears Roche, Lilly Alzheimer’s Blood Test for Patients 55 and Older
3 articles · Updated · Forbes · Aug 24
Summary
Roche and Eli Lilly won FDA clearance for the Elecsys Phospho-Tau 217P Plasma test, a blood-based tool to help identify amyloid pathology linked to Alzheimer’s in patients over 55.
The test offers a less invasive, cheaper alternative to PET scans and cerebrospinal fluid testing, and Roche said labs can run it within existing workflows without buying new equipment.
Roche and Lilly said the assay is not a standalone Alzheimer’s diagnosis and should be read alongside other clinical information; Labcorp and Quest Diagnostics plan to offer it.
The clearance follows the FDA’s first Alzheimer’s blood-test authorization in May, as 6.7 million older U.S. adults live with diagnosed Alzheimer’s and the CDC expects that number to double by 2060.