SINGAPORE - A home-grown biotech company has begun a large-scale clinical study for a blood test that can offer early screening of up to nine different cancers that have high mortality rates.

The test by Mirxes uses a combination of biomarkers to screen for lung, breast, colorectal, liver, stomach (gastric), oesophageal, ovarian, pancreatic and prostate cancers.

Biomarkers are measurable DNA, RNA or protein components that indicate disease such as cancer.

The test is the first in the world to use this unique combination of blood-borne circulating microRNA (miRNA) and DNA methylation biomarkers to detect multiple cancers.

Early detection of cancer is critical for patient survival. For example, a patient diagnosed with early stage lung cancer has a more than 80 per cent chance of survival compared with just 10 per cent for patients diagnosed with late-stage lung cancer.

Dr Zhou Lihan, co-founder and chief executive of Mirxes, said: “The goal is simple: To move the stage of cancer diagnosis from stages 3 and 4 - which is often the case now - to stages 1 and 2, based on a single blood test. This will improve survival rates easily by 50 per cent and possibly cut down the actual treatment costs.”

Called Project CADENCE, the study will receive an investment of at least $50 million over a three-year period, and is expected to recruit more than 12,000 individuals in Singapore, Mirxes said in a press statement on Thursday (July 7).

There are also plans to expand recruitment overseas, from countries such as the United States, China and Japan. 

The study will also create more than 80 new positions here in research, manufacturing and data science over the next three years.

Singapore has seen a reduction in some types of cancer, such as lung cancer as smoking incidence falls.

But other cancers continue to creep upwards in tandem with changes in lifestyle and the ageing population, Health Minister Ong Ye Kung, who was the guest of honour at the announcement ceremony, said on Thursday.

“Despite this, the Singapore population is under-screening  for cancer...We will try to correct this with Project CADENCE,” Mr Ong said.

“Hence, Project CADENCE is well-aligned with Healthier SG. When we embarked on Healthier SG, we positioned it as shifting from acute care to preventive care. This can really happen in a big way because of technological advancements,” he added.

Healthier SG represents a nationwide shift away from the traditional emphasis on illness-based hospital care towards a focus on preventive care. It keeps a lid on rising healthcare costs by tackling the problem at its roots, keeping people healthy for longer so they require less medical care.

“You can imagine that, in the future, genome sequencing will allow us to identify segments of society who may be slightly more susceptible to certain diseases, and very early interventions can take place. Simple interventions – exercise, diet – can be done because we can identify early who is more susceptible to certain chronic illnesses,” Mr Ong said.

On Thursday, Mr Ong witnessed the signing of a Memorandum of Understanding (MOU) between Mirxes and the National Cancer Centre Singapore, Nanyang Technological University, Singapore, National University Hospital, Singapore General Hospital, Singapore Translational Cancer Consortium, Tan Tock Seng Hospital and the Yong Loo Lin School of Medicine.

The MOU creates a new public-private partnership to address the rising incidence of cancer here and the cost savings that would arise from early cancer detection.

The research is expected to recruit more than 12,000 individuals, including healthy average-risk individuals, high-risk individuals, patients with benign conditions and newly diagnosed patients who have not received cancer treatment before.

It also expects to produce a significant number of intellectual property rights created on single- and multi-cancer biomarkers and test kits.

The intellectual property rights will be shared by Mirxes, the institutes of higher learning and public healthcare institutions, and the resulting blood test kits will be prototyped, manufactured, and commercialised by Mirxes.

Professor Yeoh Khay Guan, lead principal investigator for the project, said: “Success in this venture would produce a game changer and a major breakthrough, a first of its kind blood test that can accurately detect early cancers and save many lives.”

The Straits Times spoke to Dr Zhou about the project:

Q: What is Mirxes and what does Project CADENCE stand for?

A: Founded in 2014, Mirxes is a biotechnology company based in Singapore and a spin-off from the Agency for Science, Technology and Research (A*Star). Headquartered in Singapore, it also has operations in the United States, China, and Japan. 

CADENCE stands for: CAncer Detected Early caN be CurEd.

Q: What are some details of the Project?
A: Project CADENCE comprises two phases. The first phase will take place between 2022 and 2024 to identify and develop the blood test. The aim is for the new test to surpass existing blood-based cancer biomarker tests, since it has  higher sensitivity, which allows for early detection of cancers, and higher specificity, which  allows for identification of the cancers.

In phase two, the goal is to implement the new blood test at the population level.
 

Q: Why are we looking at microRNA (miRNA) and DNA?

A: MicroRNA and DNA methylation biomarkers are the two classes of blood biomarkers most investigated for early detection of cancer in recent years. Based on research, microRNAs are actively released by cancer cells and thus allow more sensitive detection of early stage cancer.

On the other hand, DNA methylation biomarkers can be highly specific to certain cancer types. To develop a blood test that can detect multiple cancers early, there needs to be a balance between sensitivity and specificity - where the test is able to pick up the disease when it is in its early stages as well as identify the type of cancer it belongs to. Hence the combination of microRNA and DNA methylation is being used.

Currently, most cancers are detected late, at stage 3 and stage 4.

Project CADENCE hopes to detect cancers at stage 1 and 2. The survival rate of a stage 1 cancer patient can be more than 90 per cent, whereas the survival rate of stage 3 and 4 patients is typically below 30 per cent.

Q: What is the difference between existing technology and this new technology in Project CADENCE?

A: Existing tumour markers are protein based and generally have insufficient sensitivity - below 50 per cent - towards early stage cancers. They may also lack the specificity in differentiating the different types of cancers. For some cancers, such as lung cancer and stomach cancer, no screening is available at all. 

The new blood test will fill the gap in screening and also make it convenient and affordable:  With a single blood draw, multiple cancers can be detected. 

Q: What is the cost like?

A: As this study is only in its research phase, the cost has yet to be determined. However, Mirxes is committed to making it affordable.

“If you look at our annual health screening, it can range from about $600 to over $1,000, depending on the type of test taken. The goal is to make the new test fit into the same price range and replace some of the current tests. So the aim is to have a minimal increase in cost, but a huge increase in accuracy and the ability to detect cancer,” Dr Zhou said.