Mirxes Co-Founder and CEO Dr Zhou Lihan
Mirxes Holding develops and commercialises non-invasive and affordable blood-based miRNA test kit products for the early detection of cancer and other diseases.
The Singapore-headquartered RNA technology company announced closing its US$50 million Series D funding round led by Beijing Fupu, EDBI, Mitsui & Co., NHH Venture Fund, and the Agency for Science, Technology and Research.
Mirxes, founded in June 2014 as a spin-off from A*STAR, was conceptualised and developed by co-founders Dr Zhou Lihan, Prof. Too Heng-Phon, and Dr Zou Ruiyang.
The startup recently announced the completion of its US$50 million Series D funding round led by Beijing Fupu, EDBI, Mitsui & Co., NHH Venture Fund, and the Agency for Science, Technology and Research.
e27 spoke with Co-Founder and CEO Lihan to learn more about the company, its solutions, and future plans.
Can you provide an overview of Mirxes’s RNA technology and how it is utilised in cancer detection?
Mirxes has developed a microRNA (miRNA) technology platform, mSMRT-qPCR, based on RT-qPCR. The platform relies on our unique three-primer approach, which can accurately and reliably measure miRNAs in human blood by increasing detection sensitivity and reproducibility.
Our early detection test kits are powered by our proprietary and patented miRNA detection technology platform. With extensive research into disease biomarkers, we have gained an in-depth understanding of the unique biology of miRNA, particularly at the early stages of the disease. Leveraging on our research and technology, we can develop and offer a new class of blood-based miRNA test solutions that significantly outperform existing tumour marker tests in detecting early stages of cancers.
Mirxes harnesses the power of RNA with a proprietary technology that can detect abnormal miRNA signatures in bodily fluids like blood and saliva. Consequently, with a simple prick, clinicians can diagnose diseases even in the early stages.
How does Mirxes’s blood-based colorectal gastric cancer screening test work, and what sets it apart from traditional screening methods?
GASTROClear is the first and only approved molecular in vitro diagnostic (IVD) product for gastric cancer screening globally, according to Frost & Sullivan. GASTROClear sets the standard for miRNA- based diagnostic tests.
Also Read: Harnessing the power of AI to help improve gastric cancer detection
Equipped with our mSMRT-qPCR technology, GASTROClear has demonstrated outstanding clinical performance. We completed a prospective clinical trial with 5,282 people enrolled in Singapore in a clinical trial for cancer screening and early detection.
GASTROClear is:
• non-invasive and simple to use: it provides a non-invasive testing approach as it requires only 1 ml of blood for testing, making the sampling process easy and enabling GASTROClear to be used in various testing scenarios.
• cost-efficient and highly accessible: our proprietary mSMRT-qPCR technology platform and reagents, together with our in-house manufacturing capabilities, enable us to control operational costs effectively, therefore lowering the costs of GASTROClear and making it highly accessible in the market.
• convenient: it can quantify risk levels and present direct and actionable detection results, thus enabling early detection and intervention of diseases. It also has a fast turn-around time, with a 4-hour sample-to-result lab workflow.
Project CADENCE sounds promising for early cancer detection. Can you share more details about the multi-cancer early detection test and the nine high-mortality cancers it aims to detect?
Project CADENCE is the world’s first large-scale clinical research project in Singapore to discover and validate novel combinations of blood-borne circulating miRNA and DNA methylation biomarkers. It will lead to developing a multi-cancer early detection test for up to nine high-incidence and high-mortality cancers, including lung, breast, colorectal, liver, stomach (gastric), oesophagal, ovarian, pancreatic, and prostate cancers.
We initiated a large-scale clinical research project in July 2022 to develop CADENCE in collaboration with key clinical experts and institutions in Singapore and overseas through integrating and analysing multi-omics biomarkers in miRNA and DNA of more than 20,000 individuals.
As part of our plans to bring accessible and affordable early cancer detection solutions to the ASEAN region, we signed a memorandum of understanding with PT ELION MEDIKA INDONESIA to bring RNA-powered early cancer detection tests to Indonesia. Similar to Project CADENCE, the partnership aims to develop blood-based multi-cancer early detection solutions optimised for the Indonesian population. This collaboration further enabled leading Indonesian and Singaporean scientists, clinicians, and entrepreneurs to develop localised solutions to address cancer challenges in our region collectively.
How does Mirxes’ RNA technology synergise with other biomarker technologies in Project CADENCE, and what advantages does this integration offer for cancer detection?
Project CADENCE is our most ambitious effort to date, where we 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 allows physicians and at-risk individuals to detect the earliest possible signs of multiple solid cancers. This is done through a holistic analysis of miRNA and DNA biomarkers. The biomarker discovery and test development phase seeks to surpass existing blood-based cancer biomarkers with superior clinical performance in sensitivity and specificity.
Aligned with our purpose to detect cancer in its early stages to alleviate the burden of the disease and reduce financial costs, Mirxes has initiated a large-scale clinical research project for the development of CADENCE in collaboration with key clinical experts and institutions in Singapore and overseas, through integrating and analysing multi-omics biomarkers in miRNA and DNA of more than 20,000 individuals. We intend to conduct registration clinical trials for CADENCE in selected countries.
What are the key benefits of early cancer detection?
Early detection improves treatment outcomes and healthcare costs, and timely intervention leads to more effective treatment options and chances of successful outcomes. Treating cancer at later stages can be more expensive due to the need for more aggressive treatments and a higher likelihood of complications. Mirxes believes early detection saves lives and can also help reduce the overall cost burden on healthcare systems and patients.
What is your strategy for expanding cancer detection solutions into international markets? Which new markets are you expanding into? What opportunities do you see there?
Mirxes is headquartered in Singapore. Globally, we have physical operations in the US, China (including Hong Kong), Japan, and Southeast Asia (the Philippines and Malaysia) and commercial activities in broader Asia-Pacific markets.
We have established strong partnerships with our customers, distributors, suppliers and government partners and tailored our core strategy, products and services for each geography. This means that we ensure solid in-market relevance in each respective country alongside first-mover advantages, delivering solutions that work best for consumers.
For example, our early disease detection portfolio holds huge market potential to address significant unmet clinical demand. The successful commercialisation of GASTROClear alongside LungClear, a commercialised miRNA-based lung cancer early screening LDT service, positions us to seize global opportunities and make further inroads into cancer early detection.
Other key players in the global molecular cancer screening market with approved products include Exact Sciences’ Cologuard (stool DNA test for colorectal cancer), which was approved by FDA in 2014, and New Horizon Health’s ColoClear (stool DNA test for colorectal cancer) which was approved by NMPA in 2020. Mirxes’s GASTROClear was approved by Singapore’s Health Sciences Authority in 2019 and obtained the FDA Breakthrough Device Designation in 2023 while undergoing clinical trial in China for the NMPA approval. We seek to conduct clinical trials in different regions to localise our products and benefit more communities, as cancer is a personalised disease.
In Southeast Asia, we have established ourselves as a market leader in speciality molecular diagnostic development, allowing us to develop and commercialise products and services more efficiently. Our strategic focus is to continue demonstrating our capabilities to provide affordable and effective healthcare solutions to consumers in the region.
In July 2023, we announced our listing application with The Stock Exchange of Hong Kong Limited (HKEX) under Chapter 18A of the Rules Governing the Listing of Securities on HKEX. IPOs are a means for tech companies to secure funding for Research and Development (R&D), driving innovation and progress. We view IPOs as milestones, not endpoints. Going public isn’t about cashing out; it’s about accessing capital for new innovative breakthroughs, market growth and expansion. Our peer companies in the biotech sector usually go to IPO within 6-8 years of company founding (Exact Sciences, New Horizon Health, Guardant Health etc). Chapter 18A listing rule was specifically set up to enable growth-stage biotech companies that are pre-revenue or pre-profit to raise capital publicly to accelerate pipeline R&D and product commercialisation.
The spread of cancer remains a significant global health concern. How does Mirxes plan to address this challenge with its innovative technologies and early detection solutions? Which part of the world is more prone to cancer and why?
The prevalence of cancer can vary across different regions of the world due to various factors such as lifestyle, environmental exposures, genetics, and access to healthcare. Some regions may be more prone to specific types of cancer due to the mentioned factors.
Specific to gastric cancer:
Gastric cancer is the fourth leading cause of cancer deaths. It is ranked the sixth in global incidences among all cancers in 2022, with a total of approximately 1.1 million incidences worldwide, according to Frost & Sullivan. It is widely accepted that gastric cancer is one of the most preventable cancers because screening of asymptomatic individuals can identify precancerous adenomas that can be removed through surgery before they become cancerous. Patients diagnosed early in the progression of the disease are more likely to have a complete recovery and incur fewer medical expenses.
According to Frost & Sullivan, the market size of gastric cancer screening in the selected regions (namely China, Japan, Southeast Asia and the U.S.) increased from US$11.6 billion in 2018 to US$14.6 billion in 2022. It is expected to increase to US$20.7 billion in 2027 and US$24.3 billion in 2032.
Mirxes aims to make early disease detection accessible on a global scale. We aim to alleviate the burden of cancer and reduce healthcare costs by leveraging innovative RNA tests that detect diseases earlier, improving health economics and outcomes to foster a healthier future for communities worldwide.
Apart from colorectal cancer and the nine high-mortality cancers targeted in Project CADENCE, does Mirxes plan to expand its RNA technology to detect other types of cancer in the future?
We are focused on scaling the adoption and penetration of Mirxes’s flagship stomach cancer blood test, GASTROClear, in major Asia-Pacific markets, including Southeast Asia, China, and Japan. We will also accelerate the development and commercialisation of Mirxes’s maturing clinical pipeline, including a blood-based colorectal cancer screening test and the multi-cancer early detection test under Project CADENCE. We have a strong oncology-focused pipeline to address clinical unmet needs for a healthier world – lung, breast, colorectal, liver and ovarian cancer, and multi-cancer.
In addition to our clinical pipeline of test kits for various cancers, we continue to work with local and globally renowned academic clinical centres to grow our pulmonary and cardiovascular disease portfolios.
In 2022, Mirxes jointly launched Southeast Asia’s first multi-centre study, Singapore Pulmonary Hypertension Early Detection with miRNA biomarkErs (SPHERE), with National University Heart Centre, Singapore (NUHCS) and National Heart Centre Singapore (NHCS) in a nationwide effort to manage the risk of pulmonary hypertension. SPHERE aims to develop miRNA signatures pertinent to Asia for early pulmonary hypertension (PH) detection.
Our ultimate focus continues to be on accelerating innovation and bringing life-saving solutions to the public through the early detection of life-threatening diseases.
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(The second image used in this picture is AI-generated)
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