Pharma companies collaborate on early Alzheimer’s diagnoses

Roche has announced its collaboration with its counterpart Eli Lilly to try to achieve early diagnosis of Alzheimer’s disease using the diagnostic Elecsys Amyloid Plasma Panel – testing blood plasma for key Alzheimer’s disease markers.

The pharmaceutical companies  want to boost the development of Roche’s Elecsys Amyloid Plasma Panel (EAPP), an ‘innovative blood test’ looking to enhance earlier diagnoses.

Mark Mintun, Lilly group vice president for Neuroscience R&D and president of Avid Radiopharmaceuticals said:

“We are pleased to be joining Roche to support the development of yet another potential diagnostic tool.”

The companies say they want to work together to address unmet need created by  barriers to accurate, early diagnoses of Alzheimer’s disease across the world.

Some 75% of people who live with Alzheimer’s disease experience symptoms of the condition but have no formal diagnosis.

The World Health Organisation (WHO) has set a global target for diagnosis of  a minimum of 50% of the estimated number of people with dementia to be diagnosed by 2025 in at least 50% of member countries.

Age Scotland has called for a focus on early diagnosis and preventative care to reduce the mortality rate of Alzheimer’s disease.

Estimates suggest that approximately 90,000 people currently live with dementia in Scotland – with around only 64% of people affected receiving a diagnosis.

By increasing access to diagnosis and improving the pathway from diagnosis to treatment, Roche and Lilly aim to support more people to receive a faster diagnosis.

The partners ultimately want to enable access to the most effective new therapies for patients as they become available. Matt Sause, CEO of Roche Diagnostics said collaboration is key to this:

“We are excited to be collaborating with Lilly on such an important area of unmet medical need. Today, over 55m people are living with dementia and this is projected to increase to nearly 140m by 2050.

“Collaboration is essential to ensure these people receive a timely and accurate diagnosis. The Elecsys Amyloid Plasma Panel has the potential to streamline a person’s journey to diagnosis and, therefore, access to future treatment options.”

In July, Roche announced that the US Food and Drug Administration (FDA) granted EAPP ‘Breakthrough Device Designation’ while in December 2022, FDA 510 (k) clearance was received for the two assays involved in this plasma panel.

This means the components for the EAPP have been through the formal medical device manufacture process and accepted for use in the USA.

How does the plasma panel help diagnosis?

The EAPP works by measuring two key markers in human blood plasma: the phosphorylated Tau (p-Tau) 181 protein assay and the apolipoprotein (APOE) E4 assay. Each test takes around 20 minutes.

Elevations in the first, p-Tau181, are linked to the early stages of Alzheimer’s disease. Researchers have found that patients with mild and very mild cognitive impairment due to Alzheimer’s disease had increased levels of p-Tau181 compared to healthy control patients.

A 2022 study investigating biomarkers for preclinical Alzheimer’s disease found that p-Tau181 may be a ‘broadly available and cost effective’ biomarker for identifying and assessing the severity among individuals with preclinical Alzheimer’s disease.

The second marker that EAPP measures, APOE4, is considered the most common indicator for genetic risk of Alzheimer’s disease. The presence of APOE4 is associated with an increased risk of Alzheimer’s and a lower age of disease onset.

By measuring these two markers, results from the plasma panel are intended to be used alongside other clinical assessment and to advise for further confirmatory testing.

Roche states that:

‘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.’

If approved the EAPP test would be an additional tool to identify the likelihood of these protein markers in the cause or progress of a patient’s symptoms and determine the next stages of evaluation – supporting early diagnosis.

Lilly’s Mark Mintun added:

“We look forward to the robust data and continued collaboration across the field that will be critical to accelerate the ecosystem to aid in a timely and accurate diagnosis of Alzheimer’s.”