NEW YORK – Roche has licensed a phosphorylated-tau 217 antibody from diagnostics firm ALZpath that the pharmaceutical giant plans to incorporate into diagnostic blood tests it's developing for Alzheimer's disease, ALZpath said Monday.
Roche will use the pTau217 antibody to develop and commercialize a blood test for early-stage Alzheimer's that will be offered on the company's Elecsys testing platform. Roche's pTau217 test, which was recently granted breakthrough device designation by the US Food and Drug Administration, is being commercialized as part of a collaboration with Eli Lilly to develop blood-based Alzheimer's tests.
Blood tests could be a boon for a growing class of Alzheimer's drugs that specifically target beta-amyloid plaque, an accumulation of proteins that is a hallmark of the disease and that currently requires more expensive and invasive options to detect, such as PET scans or cerebrospinal fluid analyses. Eisai and Biogen's Leqembi (lecanemab), which was approved by the FDA last year, is only indicated for Alzheimer's patients with confirmed amyloid pathology. Lilly is seeking approval for its investigational drug donanemab, which is currently under FDA review, also for early Alzheimer's patients with confirmed beta-amyloid plaque.
pTau217 has emerged as a blood-based biomarker that's highly predictive of beta-amyloid positivity, and some experts say such blood tests may eventually be able to be used as standalone confirmatory tests.
"Incorporating a diagnostic reagent like the ALZpath pTau217 antibody into widely used diagnostic platforms such as the Roche Elecsys could help transform Alzheimer's disease research," said Sterling Johnson, an adviser to ALZpath, in a statement. "With time, the test could ultimately be used to screen and to help avert the clinical onset of Alzheimer's disease when effective prevention therapies become available."