A project for the discovery and validation of new combinations of biomarkers that can detect multi-cancer early has been launched in Singapore.
Biotechnology company, MiRXES Ptr Ltd, announced this week the signing of a memorandum of understanding signaling the launch of Project CADENCE (Cancer Detected Early caN be CurEd).
It is the world’s first large-scale clinical research project for the discovery and validation of combinations of blood-borne circulating microRNA (miRNA) and DNA methylation biomarkers that enable the development of a multi-cancer early detection test for up to nine high incidence and high mortality cancers including lung, breast, colorectal, liver, stomach (gastric), esophogeal, ovarian, pancreatic and prostate cancers.
The signing was witnessed by Ong Ye Kung, MiRXES signed the understanding together with a range of hospitals, medical centers and universities.
Healthcare clusters
This represents a new public-private partnership where Project CADENCE, a global effort championed by clinician-scientists from Singapore’s institutes of higher learning and public healthcare institutions represented by all three healthcare clusters, powered by MiRXES, that aims to address the rising cancer incidence rate and economic impact in Singapore and globally through early detection.
Project CADENCE will receive an investment of an estimated S$50 million ($35.6 million) and more by MiRXES over a three-year period, with substantial in-kind contributions from the higher learning and healthcare institutes.
This 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, treatment native cancer patients, and produce a significant number of intellectual property rights created on single- and multi-cancer biomarkers and test kits.
The initiative will fortify Singapore’s leadership position in molecular cancer early detection solutions. The intellectual property rights will be shared by MiRXES, IHLs and PHIs, and the resulting blood test kits will be prototyped, manufactured, and commercialized by MiRXES.
New positions
Project CADENCE will also see the creation of more than 80 new positions in research, manufacturing, and data science over the next three years.
Zhou Lihan, co-founder and CEO for MiRXES, said: “Since MiRXES was founded in 2014, we have been focused on being a global leading miRNA technology innovator and cancer early detection test developer. Following our 2019 launch of GASTROClear, the world’s first miRNA-based blood cancer early detection test, Project CADENCE is our most ambitious effort to date.
“This is where we will leverage our proprietary technologies, a decade long RNA clinical test development experience, and Singapore’s strong clinical research and translation infrastructure, to develop a novel blood test that offers physicians and at-risk individuals the earliest possible signs of multiple solid cancers through a wholistic analysis of miRNA and DNA biomarkers.
“MiRXES’s investment in Project CADENCE is timely as we continue to accelerate the development and commercialization of miRNA-powered in vitro diagnostic blood tests in oncology as well as pulmonary and cardiovascular disease areas.”
Project CADENCE comprises two phases. First, the biomarker discovery and test development phase between 2022 to 2024 will seek to surpass existing blood-based cancer biomarkers with more superior clinical performance in sensitivity and specificity.
It aims to identify novel combinations of miRNA and DNA methylation biomarkers to achieve better performance than existing tests, this phase will involve high-throughput, in-depth multi-omics analysis of the blood miRNA and DNA signatures of 12,000 individuals.
The resulting cancer biomarkers will then be prototyped into a blood based multi-cancer early detection (MCED) test, manufactured in MiRXES’s newly opened Industry IVD Manufacturing Facility in Singapore, under strict analytical and clinical validations by laboratory partners.
Optimizing
Implementation and clinical utility will take place in the second phase from 2024, with the goal of optimizing large-scale clinical implementation workflow and to demonstrate the utility of a MCED test in shifting today’s late stage cancer diagnosis to earlier stages. The second phase could see a longitudinal population cohort of more than 100,000 participants, including both average-risk and high-risk cancer individuals.
Yeoh Khay Guan, lead principal investigator for the project said, “Project CADENCE combines the efforts of cancer experts from all three healthcare clusters in Singapore with MiRXES’ cutting edge nucleic acid technology in a national effort to address an unmet need.
“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.”
Together with the signing of the understanding, MiRXES also opened doors to two key laboratories at Biopolis, built through the COVID-19 pandemic – MiRXES Lab which is an ultra-high-throughput RNA research laboratory, and M Diagnostics a state-of-the-art molecular diagnostic laboratory.