Roche Showcases Advancements in Alzheimer’s Diagnostics at CTAD 2024

Roche Showcases Advancements in Alzheimer’s Diagnostics at CTAD 2024

(IN BRIEF) At the CTAD 2024 congress in Madrid, Roche presented new data on its Elecsys® Amyloid Plasma Panel and Elecsys ptau181, demonstrating their effectiveness in diagnosing Alzheimer’s disease. The blood-based test showed a negative predictive value of 96.2% in ruling out Alzheimer’s-related amyloid pathology, potentially eliminating the need for invasive testing. Conducted across the US and Europe with 492 participants, the trial indicated strong performance across diverse demographics. Matt Sause, CEO of Roche Diagnostics, highlighted the test’s ability to provide reassurance to patients and facilitate timely diagnoses. With a significant portion of individuals with Alzheimer’s remaining undiagnosed, Roche aims to expedite the diagnostic process and is well-positioned to rapidly scale testing capabilities upon regulatory approval, reinforcing its commitment to advancing Alzheimer’s diagnostics and therapies.

(PRESS RELEASE) BASEL, 31-Oct-2024 — /EuropaWire/ — On October 31, 2024, Roche (SIX: RO, ROG; OTCQX: RHHBY) presented new data on its Elecsys® Amyloid Plasma Panel and Elecsys ptau181 at the 17th Clinical Trials in Alzheimer’s Disease congress (CTAD) in Madrid, highlighting significant progress in diagnostics for Alzheimer’s disease. The data demonstrated the test’s potential to accurately rule out Alzheimer’s-related amyloid pathology, potentially eliminating the need for further invasive procedures.

This innovative blood-based test has emerged from the largest clinical trial of its kind, showing a remarkable negative predictive value (NPV) of 96.2% in ruling out Alzheimer’s disease in patients undergoing evaluation for cognitive impairment. Conducted across multiple centers in the US and Europe with 492 participants, the trial indicated that the test performed consistently well across diverse demographics, including various age groups and health conditions.

Matt Sause, CEO of Roche Diagnostics, commented on the study’s findings, stating, “The results suggest that a straightforward blood test could reliably rule out amyloid pathology, providing crucial reassurance for patients and their families. Alzheimer’s disease is a pressing global health challenge, and this test could help facilitate timely and accurate diagnoses, enabling patients to receive appropriate care sooner.”

The Elecsys Amyloid Plasma Panel, which received FDA Breakthrough Device Designation in July 2023, measures phosphorylated Tau (pTau) 181 protein and apolipoprotein E4 in plasma. It represents a pioneering effort in the industry to assess clinical performance in a patient population reflective of those who would benefit from such testing. The study included a diverse array of patients to ensure broad applicability across different regions and ethnicities.

Roche also presented data for its Elecsys pTau 217 assay, which is currently under development and has similarly received FDA Breakthrough Device Designation this year. The findings reveal high accuracy in detecting amyloid pathology when compared to other existing tests.

With up to 75% of individuals experiencing Alzheimer’s symptoms remaining undiagnosed, Roche is addressing critical barriers to early diagnosis. On average, patients wait 2.8 years after the onset of symptoms for a formal diagnosis. The company emphasizes the importance of expediting the diagnostic journey to ensure timely access to emerging therapies.

Roche’s extensive network of established solutions positions it well to rapidly scale testing capabilities once regulatory approvals are obtained, ensuring that patients can access these advancements promptly. Committed to improving detection and treatment of Alzheimer’s disease, Roche is developing comprehensive solutions to diagnose and monitor the condition effectively while advancing research into investigational therapies.

For further insights into Roche’s progress in Alzheimer’s diagnostics and treatment, additional information is available through their official channels.

About the Elecsys Amyloid Plasma Panel
This product is currently under development and not commercially available. The below information reflects Roche’s plans for these products if they are approved by regulatory bodies for clinical use in the future:

The Elecsys Amyloid Plasma Panel measures phosphorylated Tau (pTau) 181 protein assay and apolipoprotein (APOE) E4 assay in human blood plasma. Elevations in pTau181 occur in the early stages of Alzheimer’s disease, while the presence of APOE4 constitutes the most common genetic risk factor for Alzheimer’s disease. The result is intended for consideration in conjunction with other clinical information to advise for further confirmatory testing with amyloid positron emission tomography (PET) or cerebrospinal fluid (CSF) testing. Patients testing negative with the Elecsys Amyloid Plasma Panel are unlikely to be amyloid positive and should be investigated for other causes of cognitive decline.

About Elecsys pTau217
This product is currently under development and not commercially available. The below information reflects Roche’s plans for these products if they are approved by regulatory bodies for clinical use in the future:

Elecsys Phospho-Tau (217P) is intended to be an in-vitro diagnostic immunoassay for the quantitative determination of the protein Phospho-Tau (217P) (pTau217) in human plasma from individuals aged 60 years and older. The test is intended for use as an aid in identifying amyloid pathology, a pathological feature of Alzheimer’s disease.

• A positive Elecsys pTau217 result indicates a high likelihood of having a positive amyloid PET/CSF result.
• A negative Elecsys pTau217 result indicates a high likelihood of having a negative amyloid PET/ CSF result.
• An indeterminate pTau217 result indicates uncertainty on the amyloid PET/CSF result. The pTau217 result should be used in the diagnostic pathway in conjunction with other clinical information.

About Roche in Alzheimer’s disease
With more than two decades of scientific research in Alzheimer’s disease, Roche is working towards a day when we can detect and treat the disease early, in order to stop or even prevent its progression to preserve what makes people who they are. Today, the company’s Alzheimer’s disease portfolio spans investigational medicines for different targets, types and stages of the disease, including trontinemab. On the diagnostics side, it also includes approved and investigational tools, including digital and blood-based tests and CSF assays, aiming to more effectively detect, diagnose and monitor the disease. Yet the global challenges of Alzheimer’s disease go well beyond the capabilities of science, and making a meaningful impact requires collaboration both within the Alzheimer’s community and outside of healthcare. Roche will continue to work together with numerous partners with the hope to transform millions of lives.

About Roche
Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.

For over 125 years, sustainability has been an integral part of Roche’s business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045.

Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.

All trademarks used or mentioned in this release are protected by law.

References
[1] Kirste I, et al, Revamping Alzheimer’s Disease Diagnostics: Evaluating Future IVD Plasma p-Tau 181 and ApoE4 Immunoassays for Amyloid Detection in a Multi-Center Study Reflective of Routine Clinical Practice, presented at CTAD, October 2024.
[2] Life Expectancy Following Diagnosis Of Alzheimer’s Disease Depends On Age At Diagnosis, Johns Hopkins Bloomberg School of Public Health, November 18, 2002, https://publichealth.jhu.edu/2002/alzheimer-age

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SOURCE: Roche