A simple blood test that can detect and screen with 96% accuracy whether a person has Alzheimer’s disease up to a decade before symptoms appear, has been made available to the general public for the first time.

The blood test developed by an international research team led by scientists from the Hong Kong University of Science and Technology (HKUST), could be a potential game changer in the battle to catch and treat the neurodegenerative disease in its early stages.

The PlasmarkAD Blood Test Service is currently only available to patients in Hong Kong at a cost of HK$7,000 (£693 or $894 US).

But Dr Joyce Ouyang, managing director of Hong Kong-based Cognitact, which has licensed the medical breakthrough, has told Agetech World that its rollout in the Chinese city-state potentially paves the way for a cheap and easy diagnosis of Alzheimer’s, that could eventually help millions of people across the globe begin early treatment for the devastating disease.

She said: “It was easier for us to launch in Hong Kong because we are based here, and because of the regulatory framework, but we do plan to extend this to other parts of the world. We need to see how it goes in Hong Kong first, but we do have plans for further commercialisation.

“We think we will seek the possibility of whether it could expand into the UK or Europe through our connections there.”

It is hoped that ultimately the blood test could open the door to novel therapeutic treatments for Alzheimer’s and perhaps be adapted to help detect other neurodegenerative diseases, as Dr Ouyang explained. “The next step is to see if the test can be used for other types of dementia, like frontal FTD (frontotemporal dementia). That would be the first priority.

Dr Joyce Ouyang, managing director of Hong Kong-based Cognitact

“Currently we are using a quite expensive method, that is why our current test is not cheap. But, of course, it is cheaper than other conventional, traditional methods. We do need to do some more research and development, however, to develop some other cheaper methods for the blood test diagnosis.

“Why it is expensive is because we are using a quite costly platform. We are measuring something from the blood to reflect what is happening in the brain, so sometimes these protein levels in the blood are quite low, so that is why we need to use an expensive method to achieve the ultra sensitive detection of those protein levels.

“The plan is to develop a cheaper method to achieve the sensitive detection of those biomarkers. We hope that this can be faster, and in this we are collaborating with other companies to focus on the biotech for the protein part to see whether we can figure out another method to achieve the ultra-sensitive detection and also more cheaply.

“We hope that this will facilitate the test to go further and quicker and cheaper.”

The PlasmarkAD test has taken around five years to develop in collaboration with scientists from University College London (UCL) and clinicians in Hong Kong hospitals, including the Prince of Wales and Queen Elizabeth, with the researchers using Chinese patient data to progress it.

The blood test is aimed at those who are concerned about developing Alzheimer’s. Individuals book an appointment online and do the test at designated centres.

It uses a single drop of blood to determine if a person has Alzheimer’s disease, which affects around 55 million people globally.

In Europe alone, the number of people with dementia – of which Alzheimer’s disease is the most common type – is expected to almost double by 2050, increasing to more than 14 million in the EU and nearly 19 million in the wider region.

Early detection of the progressive disease which damages the brain and often begins with mild memory loss, is key to slowing its effects.

There is currently no cure with an average life span for patients of 10 years post-diagnosis.

Given the devastating effects of the disease and how common it is becoming, the need for more diagnostic tools that can pick up on its presence early and hopefully help slow cognitive decline, has become a scientific cause célèbre.

Currently, Alzheimer’s is typically diagnosed via neuroimaging and analysis of cerebrospinal fluid collected via a lumbar puncture.

But a lumbar puncture can be invasive and painful and brain scans expensive with potentially long waits to both get an appointment and the results.

A blood test for detecting Alzheimer’s disease with 96% accuracy has become available to the public in Hong Kong.

The HKUST blood test leverages world-leading proteomic technology (the systematic analysis of proteins) and self-developed machine learning algorithms. Using this method, PlasmarkAD can detect the level changes of blood biomarkers simply through regular blood draws, and accurately evaluate the instant probability of a person developing Alzheimer’s disease.

Dr Ouyang received her bachelor’s degree at Nanjing University and her PhD from HKUST after which she continued her neuroscience research in Hong Kong for neurodegenerative diseases. Her own research focuses on elucidating the molecular mechanisms underlying Alzheimer’s disease pathogenesis and has identified multiple therapeutic targets for neurodegenerative disease.

She joined Cognitact with a vision of translating the biomarker research into real applications that can be used by the public.

Dr Ouyang said the team at HKUST has identified 19 out of the 429 plasma proteins associated with Alzheimer’s to form the biomarker panel representative of an “AD signature” in the blood.

She explained that based on this panel, the team has developed a scoring system that distinguishes Alzheimer’s patients from healthy people with more than  96% accuracy. This system can also differentiate early, intermediate and late stages of Alzheimer’s and be used to monitor the progression of the disease.

Most notably, this blood test can detect the presence of Alzheimer’s disease five to 10 years before symptoms appear.

Moreover, through multi-dimensional analysis of the human body systems based on the detected protein levels, Dr Ouyang said it can evaluate the status of those areas that may be affected in Alzheimer’s disease, including immune, metabolic, nervous and vascular processes, potentially providing more personalised analysis and treatments.

Dr Ouyang said early detection of Alzheimer’s is critical given that treating it remains a challenge. Patients are only diagnosed when symptoms, such as memory loss, appear. But the actual onset of the disease can be many years earlier.

“The blood test, as you know, the accuracy to detect AD indications is 96% and we can also achieve early screening and early detection of this group of people. The current clinical diagnosis is really too late, when the patient develops the symptoms. The early detection of the disease will help them to save some time. You will have the early intervention of the disease and hope that it will facilitate a cure.

This microfluidic chip will be used to perform protein biomarker measurement, which allows high-throughput sampling and ultrasensitive detection.

“It can assist the longitudinal monitoring of the disease as well. It means that if a patient has already developed AD, our blood test solution can help to evaluate the disease status and also as a way to evaluate if the treatment is having some effect on the disease, delaying the disease, or inhibiting the disease progression as well.

“So we think that our blood test solution is really helpful in the early detection, and also supports and facilitates the early disease management for patients.”

The research facility that has developed the blood test was set up by HKUST in 2020. It received HK$500m worth of government funding. Aside from the blood test, Dr Ouyang said the team is also looking at developing new genome-editing technology treatments for Alzheimer’s.

The work is helping push Hong Kong to the forefront of neurodegenerative disease research.

Current Alzheimer’s disease treatment relies on six existing drugs approved by the US Food and Drug Administration. But Dr Ouyang said they have their limitations.

“There are six drugs launched at the US FDA market for AD cure and five of them actually for the symptomatic relief only, such as the psychiatric symptoms or to reduce stress. They are not curing the disease.

“The last one is a monochloride antibody targeted AD drug launched onto the market in 2021, but because the side effects were quite severe it was withdrawn and then the same company launched another product with an enhanced efficacy.

“Of course, we hope that it can really help to treat AD, but the thinking within the team is that the disease may be diagnosed very late because when the patient really encounters the memory problem, actually the disease is already severe.

“These pathological changes in the brain are irreversible, so that is why the cure for AD does not have that much good efficacy.

“So, we hope this blood test will not only support early detection, but that through this early detection we can identify these group of people and give them early treatment so this can help them suffer less and give them a better quality of life.”

Dr Ouyang said she is confident the HKUST team will continue to play a leading role in advancing research into Alzheimer’s and neurodegenerative diseases, “to move on the development of precision diagnosis and medicine that will benefit people across the world.”