INDIANAPOLIS (dpa-AFX) - Roche (RHHBY) said that its Elecsys pTau217 assay
received Breakthrough Device Designation from the U.S. Food and Drug
Administration.

The Elecsys pTau217 plasma biomarker test is being developed as part of an
ongoing partnership between Roche and Eli Lilly and Company.

Once approved, the test will aid healthcare providers in identifying amyloid
pathology, a key feature of Alzheimer's disease, Roche said.

Roche and Lilly believe the test could play an important role in improving
access to early and accurate Alzheimer's diagnosis.

Roche noted that pTau217, which is a phosphorylated fragment of the protein tau,
is a biomarker that has shown the ability in research settings to distinguish
Alzheimer's disease from other neurodegenerative disorders and has shown strong
performance relative to other biomarkers.

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