17/06/2024, 17:52 Roche Licenses ALZpath's pTau217 Antibody for Use in Alzheimer's Blood Tests | 360Dx

Roche Licenses ALZpath's pTau217 Antibody for Use in

Alzheimer's Blood Tests
Jun 10, 2024 | staff reporter

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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."

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