Roche Unveils New Alzheimer’s Diagnostic Data at CTAD

Roche has announced promising results for its Elecsys Amyloid Plasma Panel, a blood-based test developed to rule out Alzheimer's disease-related amyloid pathology with commendable accuracy. This announcement came during the 17th Clinical Trials in Alzheimer's Disease congress held in Madrid, Spain. The Elecsys Amyloid Plasma Panel, which combines pTau181 and ApoE4 biomarkers, showed high accuracy in excluding Alzheimer's pathology in a diverse group of patients undergoing evaluation for the disease. This blood test aims to reduce the necessity for further invasive procedures.

The clinical study, which is the largest of its kind, involved 492 participants from the US and Europe. According to the data, the Elecsys Amyloid Plasma Panel achieved a high negative predictive value of 96.2%, significantly diminishing the likelihood of amyloid pathology in individuals testing negative. The test demonstrated 91.0% sensitivity and 69.8% specificity, indicating its robust performance across various patient demographics and clinical conditions. Remarkably, factors such as age, sex, body mass index, or impaired kidney function had minimal impact on the test's performance. The standalone pTau181 assay exhibited similar effectiveness.

Matt Sause, CEO of Roche Diagnostics, highlighted the significant implications of the test, emphasizing that a rapid and straightforward blood test could provide essential reassurance to patients and their families by effectively ruling out amyloid pathology. Given the growing global concern of Alzheimer's disease and its increasing prevalence as populations age, early and accurate diagnosis remains critical. The Elecsys Amyloid Plasma Panel, which received FDA Breakthrough Device Designation in July 2023, represents a significant advancement in this regard.

This minimally invasive test measures phosphorylated Tau (pTau) 181 protein and apolipoprotein (APOE) E4 in plasma. The study's prospective, multicentre design and the inclusion of a diverse patient population ensure that the test is broadly applicable across different demographics and geographies. The research also included a subset of patients from a wider trial with inclusive criteria, ensuring the test's reliability across various ethnicities. Additional potential applications of this test are currently being explored.

In conjunction with the Elecsys Amyloid Plasma Panel data, Roche also unveiled findings for its Elecsys pTau 217 assay, also in development and designated as an FDA Breakthrough Device. The pTau 217 assay has shown high accuracy in detecting amyloid pathology, further underscoring Roche's dedication to improving Alzheimer's disease diagnosis.

Globally, early and accurate diagnosis of Alzheimer's disease faces numerous obstacles. It is estimated that up to 75% of people with Alzheimer's symptoms remain undiagnosed, with those diagnosed typically waiting an average of 2.8 years after symptom onset. Addressing this diagnostic delay is crucial for reducing the burden on healthcare systems and ensuring timely access to emerging therapies. Roche's extensive network of installed diagnostic solutions positions it to scale testing rapidly once approved, ensuring patients benefit from these advancements as soon as possible.

Roche is committed to leveraging its diagnostic and pharmaceutical expertise to enhance the detection, diagnosis, and treatment of Alzheimer’s disease at its earliest stages, with the ultimate goal of preventing the disease. The company is actively developing solutions to better detect, diagnose, and monitor Alzheimer’s disease and is also progressing research into investigational treatments, such as trontinemab. This novel Brainshuttle™ Aβ antibody is engineered to enhance brain access, facilitating rapid amyloid reduction in Alzheimer's patients.

Founded in 1896 in Basel, Switzerland, Roche remains a leader in biotechnology and in-vitro diagnostics. The company is dedicated to scientific excellence to develop innovative medicines and diagnostics that improve global health. Roche's commitment to personalized healthcare and sustainability has been integral to its operations for over 125 years.