Roche (SIX: RO, ROG; OTCQX: RHHBY) announced new late-breaking data on its Elecsys Amyloid Plasma Panel (combination of pTau181 and ApoE4), for Alzheimer’s disease, at the 17^th Clinical Trials in Alzheimer’s Disease congress (CTAD) in Madrid, Spain. Results show that the test, currently in development, could accurately rule out amyloid pathology – a hallmark of Alzheimer’s disease – in a broad population with varying cognitive impairment, as seen in routine clinical practice. This could allow clinicians to rule out Alzheimer’s disease as a possible cause of cognitive symptoms with a simple blood test, offering certainty and reassurance.

In the prospective, multicentre study, which included 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 a 23.4% prevalence of amyloid positivity according to positron emission tomography (PET) scans, with 91.0% sensitivity and 69.8% specificity. The performance of the test was only minimally impacted by the patients’ age, sex, body mass index or impaired kidney function. Roche’s pTau181 biomarker performed similarly as a standalone assay.

“The data from this large-scale study in cognitively impaired individuals suggests that a fast and simple blood test could reliably rule out amyloid pathology, offering 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 issues of our time, and its impact on society is growing as the world’s population ages. For many people, getting a clear and timely diagnosis remains challenging. This test could help patients to receive the right care at the earliest opportunity.”

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 collected diagnostic registrational clinical trial) to investigate the test’s clinical performance in a patient population that reflects as closely as possible the patients who could benefit from the test. It involved a subset of patients from a wider trial looking at a highly diverse set of patients with broad inclusion criteria, to ensure the test could be used effectively across different geographies and ethnicities. Further potential uses for the test are being explored with the rich patient population.

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

Today, barriers to early and accurate diagnosis of Alzheimer’s disease exist across the globe, with up to 75% of people living with the symptoms of Alzheimer’s but without a diagnosis. Those who have received a diagnosis waited, on average, 2.8 years after symptom onset. To address the growing strain that Alzheimer’s disease is putting on healthcare systems, it will be essential to make a person’s journey to diagnosis faster and more accessible. This will ultimately enable access to appropriate new therapies as they become available. With an unmatched base of installed solutions worldwide, Roche is uniquely placed to rapidly scale testing once approved, ensuring that patients can benefit from the test as soon as it has been cleared for use.

Roche is committed to using its diagnostic and pharmaceutical capabilities in an effort to better detect and treat Alzheimer’s disease as early as possible, and working toward preventing the disease altogether. To achieve this, the company is developing and delivering solutions to more effectively detect, diagnose, and monitor the disease and progressing research into investigational medicines for different targets, types, and stages of the disease. This includes trontinemab, a novel Brainshuttle™ Aβ antibody that is currently in development and is specifically engineered for enhanced access to the brain to enable rapid reduction of amyloid in people with Alzheimer’s disease. Further data on progress in the Alzheimer’s disease pipeline will be shared with investors. For more information click here.