Roche Advances Alzheimer’s Disease Diagnosis with Breakthrough Blood Test

Breakthrough Designation:
Roche's Elecsys pTau217 blood test has received FDA breakthrough device designation for earlier diagnosis of Alzheimer's disease (AD).

Collaboration:
The test is being developed in collaboration with Eli Lilly to identify amyloid pathology, a key feature of AD.

Diagnostic Potential:
The pTau217 biomarker has shown the ability to distinguish AD from other neurodegenerative disorders and has demonstrated strong performance relative to other biomarkers.

Global Impact:
With 75% of dementia cases remaining undiagnosed, the test aims to improve access to early and accurate AD diagnosis, potentially benefiting millions worldwide.

Clinical Use:
A positive Elecsys pTau217 result indicates a high likelihood of having a positive amyloid PET/CSF result, aiding healthcare providers in identifying amyloid pathology.

Future Plans:
Roche plans to leverage its extensive diagnostic systems to ensure broad access to the test, addressing a critical need in the global fight against Alzheimer's disease.