Basel-based Roche, in collaboration with Eli Lilly and Company, has achieved a significant milestone in Alzheimer's disease diagnostics. The Elecsys pTau217 plasma biomarker test, designed to detect amyloid pathology, has secured breakthrough device designation from the U.S. Food and Drug Administration (FDA). This development promises an earlier and more accurate diagnosis, potentially altering the course of Alzheimer's disease.

The blood test, once approved, aims to revolutionise Alzheimer's diagnosis by aiding healthcare providers in identifying amyloid pathology, a hallmark of the disease. This identification is crucial for ensuring appropriate care, such as enrollment in clinical trials or access to approved therapies. The Elecsys pTau217 test is anticipated to expedite diagnosis, provide timely interventions, and potentially alleviate the burden of Alzheimer's on individuals and society.

Matt Sause, CEO of Roche Diagnostics, emphasised the global significance of dementia, with a staggering 75% of cases going undiagnosed. He stressed the pivotal role of diagnostics in addressing this pressing health challenge, expressing confidence in the Elecsys pTau217 test's potential to enhance Alzheimer's diagnosis and improve patient outcomes worldwide. Leveraging Roche's extensive diagnostic infrastructure, the company aims to ensure broad access to this transformative test.

Anne White, executive vice president of Eli Lilly and Company, highlighted the collaboration's commitment to advancing Alzheimer's diagnostics. She underscored the urgent need for additional diagnostic tools to enable timely and accurate diagnosis, emphasising the Elecsys pTau217 test's role in fulfilling this need.

The Elecsys pTau217 assay targets phosphorylated tau protein, a biomarker that has demonstrated promising capabilities in distinguishing Alzheimer's disease from other neurodegenerative disorders. With its strong performance relative to other biomarkers, the test holds the potential for enhancing diagnostic accuracy and guiding treatment decisions.

Roche and Lilly, leaders in Alzheimer's innovation, aim to accelerate testing and diagnosis in this critical area of unmet medical need through their collaboration. The Elecsys pTau217 test, designed for individuals aged 60 years and older, promises to enhance Alzheimer's diagnostics by aiding in the identification of amyloid pathology.

This breakthrough underscores Roche's extensive commitment to Alzheimer's research, spanning investigational medicines and diagnostic tools. With a portfolio targeting different disease stages and types, Roche aims to detect Alzheimer's disease early and halt its progression, ultimately preserving individuals' quality of life. Collaboration within and beyond the healthcare sector remains essential in addressing the global challenges posed by Alzheimer's disease, and Roche pledges to continue working with partners to transform millions of lives.