Roche presents new data showing increasing momentum in diagnosing Alzheimer’s disease at CTAD | 31.10.24

• New data highlight the potential of the Roche Elecsys® Amyloid Plasma Panel and Elecsys ptau181 to rule out amyloid pathology associated with Alzheimer’s disease with very good accuracy.
• In the largest clinical trial of its kind worldwide, the blood-based test showed very good accuracy in ruling out Alzheimer’s pathology in people being investigated for the disease, potentially eliminating the need for more invasive and unnecessary testing.
• The results also demonstrate Roche’s commitment to providing diagnostic clarity for Alzheimer’s disease to people in the early stages of cognitive decline.

Basel, October 31, 2024 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced new latest developments Data on the Elecsys Amyloid Plasma Panel (combination of pTau181 and ApoE4)17 year old for Alzheimer’s disease^This Congress of Clinical Research in Alzheimer’s Disease (CTAD) in Madrid, Spain. The results show that the test currently under development can accurately rule out amyloid pathology, a hallmark of Alzheimer’s disease, in a broad population with varying cognitive impairments, as seen in routine clinical practice.¹ This can provide certainty and reassurance by allowing clinicians to rule out Alzheimer’s disease as a possible cause of cognitive symptoms with a simple blood test.

In a prospective, multicenter study involving 492 patients across the US and Europe, the Roche Elecsys Amyloid Plasma Panel was able to rule out Alzheimer’s disease with a high negative predictive value (NPV) of 96.2% based on an amyloid prevalence of 23.4%. positivity with 91.0% sensitivity and 69.8% specificity based on positron emission tomography (PET) scans. Performance of the test was only minimally affected by patients’ age, gender, body mass index, or impaired kidney function. Roche’s pTau181 biomarker performed similarly in an independent assay.

“Data from this large-scale study in individuals with cognitive impairment show that a rapid and simple blood test can reliably rule out amyloid pathology, providing much-needed reassurance to patients and their families,” commented Matt Sause, CEO of Roche Diagnostics. “Alzheimer’s disease is one of the most challenging health problems of our time, and its impact on society is increasing as the world’s population ages. A clear and timely diagnosis remains challenging for many people. This test can help patients receive the right care as soon as possible.”

The Elecsys Amyloid Plasma Panel, which received FDA Breakthrough Device Designation in July 2023, is a minimally invasive blood test that measures phosphorylated Tau (pTau) 181 protein and apolipoprotein (APOE) E4 in plasma. This is the first industry trial of its kind (globally prospectively pooled diagnostic registry clinical trial) to investigate the clinical performance of the test in a patient population that reflects as closely as possible the patients who may benefit from the test. It included a subset of patients from a larger trial looking at a highly diverse group of patients with broad inclusion criteria to ensure the test could be used effectively across different geographies and ethnicities. More potential uses of the test are being explored with a rich patient population.

In addition to data on the Elecsys Amyloid Plasma Panel and pTau181, Roche also presented: Data for Elecsys pTau 217 test The device is currently in development and received FDA Breakthrough Device Designation earlier this year. The results of this latest study demonstrate the high accuracy of detection of amyloid pathology compared to another available pTau 217 test.

Today, there are obstacles to early and accurate diagnosis of Alzheimer’s disease worldwide; Up to 75% of people live with Alzheimer’s symptoms but remain undiagnosed. Those diagnosed waited an average of 2.8 years after the onset of symptoms.² To tackle the increasing burden that Alzheimer’s disease places on healthcare systems, it will be important to make a person’s journey to diagnosis faster and more accessible. This will ultimately enable access to suitable new treatments when they become available. With an unparalleled installed base of solutions globally, Roche is uniquely positioned to quickly scale tests once approved, ensuring patients can benefit from the test as soon as it is authorized for use.

Roche is committed to using its diagnostic and pharmaceutical capabilities to better detect and treat Alzheimer’s disease as early as possible and to work towards its complete prevention. To achieve this, the company develops and delivers solutions to detect, diagnose and monitor disease more effectively and advances research on investigational drugs for different targets, types and stages of disease. This includes trontinemab, a new Brainshuttle Ass antibody currently in development that is specifically designed for improved access to the brain to enable rapid reduction of amyloid in people with Alzheimer’s disease. More data on progress in the Alzheimer’s disease process will be shared with investors. Click here To access the investor presentation

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

The Elecsys Amyloid Plasma Panel measures the phosphorylated Tau (pTau) 181 protein assay and the apolipoprotein (APOE) E4 assay in human blood plasma. While elevations in pTau181 occur in the early stages of Alzheimer’s disease, the presence of APOE4 constitutes the most common genetic risk factor for Alzheimer’s disease. The result is intended to be evaluated together with other clinical information to make recommendations for further confirmatory testing by amyloid positron emission tomography (PET) or cerebrospinal fluid (CSF) testing. Patients who test 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 is not commercially available. The following information reflects Roche’s plans for these products if they are approved by regulatory authorities for future clinical use:

Elecsys Phospho-Tau (217P) is designed as an in vitro diagnostic immunoassay for the quantitative detection of Phospho-Tau (217P) (pTau217) protein in human plasma from individuals aged 60 years and over. The test is designed to be used to help identify 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 in the amyloid PET/CSF result. The pTau217 result should be used together with other clinical information in the diagnostic pathway.

About Roche in Alzheimer’s disease
With more than two decades of scientific research into Alzheimer’s disease, Roche is working towards a day when we can detect and treat the disease early to stop or even prevent the disease’s progression, keeping people as they are. Today, the company’s Alzheimer’s disease portfolio includes investigational drugs for different targets, types and stages of the disease, including trontinemab. On the diagnostic side, it also includes validated and research tools, including digital and blood-based tests and CSF analyses, aimed at detecting, diagnosing and monitoring disease more effectively. But the global challenges of Alzheimer’s disease go far 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 with its many partners in the hope of transforming millions of lives.

About Roche
Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded pharmaceuticals, Roche has grown to become the world’s largest biotechnology company and a global leader in in vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostic tools to improve and save people’s lives around the world. We are pioneers in personalized healthcare and want to further transform the way healthcare is delivered to make a greater impact. We partner with many stakeholders and combine our strengths in Diagnostics and Pharmaceuticals with data from clinical practice to provide the best care for each person.

Sustainability has been an integral part of Roche’s business for more than 125 years. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostic tools that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative towards the goal of reaching net zero by 2045.

Genentech in the United States is a wholly owned member of the Roche Group. Roche is the majority shareholder of Chugai Pharmaceutical in 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., Renewing Alzheimer’s Disease Diagnostics: Evaluation of Future IVD Plasma p-Tau 181 and ApoE4 Immunoassays for Amyloid Detection in a Multicenter Study Reflecting Routine Clinical Practice, presented at CTAD, October 2024.
(2) Life Expectancy After Alzheimer’s Disease Diagnosis Depends on Age at Diagnosis, Johns Hopkins Bloomberg School of Public Health, November 18, 2002,

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