Large-scale clinical study on use of blood test for early screening of multiple cancers
SINGAPORE – A homegrown biotech firm 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), esophageal, ovarian, pancreatic, and prostate cancers. Biomarkers are measurable DNA, RNA or protein components that indicate disease such as cancer.
It 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 over 80 per cent chance of survival compared with just 10 per cent for patients diagnosed with late-stage lung cancer.
Project CADENCE will receive an investment of at least $50 million over a three-year period, and is expected to recruit over 12,000 individuals for study, Mirxes said in a press statement on Thursday (July 7).
The study will also create more than 80 new positions in research, manufacturing, and data science over the next three years.
Currently, a number of cancer screening tools make use of biomarkers found in blood that detect the presence of cancer cells. One example is Gastroclear, a blood test that can accurately detect gastric cancer in its early stages. Traditionally, gastric cancer is diagnosed through endoscopy.
At the announcement ceremony on Thursday, Health Minister Ong Ye Kung 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 partnershipto 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, and 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 commercialized by Mirxes.
The Straits Times spoke to Dr Zhou about the project:
Q: What does Project CADENCE stand for?
A: CADENCE stands for: CAncer Detected Early caN be CurEd.
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. Survival of a stage 1 cancer patient can be over 90 per cent whereas the survival rate of stage 3 and 4 patients are 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.
On the other hand, Project CADENCE would be the first major effort to create a novel combination of blood borne microRNA and DNA methylation biomarkers for sensitive and specific detection of early-stage cancers.
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 cancer early detection tests accurate and affordable, so that these preventive healthcare solutions are accessible to all.