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Vol 24, No. 03, March 2020For e-subscribers (PDF)
COLUMNS
MiRXES — A Game Changer in MicroRNA Applications
Local Singapore-based biotech company, MiRXES Pte Ltd, spun off from the Agency for Science, Technology and Research (A*STAR) in Singapore in 2014. Their microRNA research and technology platform looks to be applied across a range of biotech uses with a current focus on diagnostic tools for disease detection.

Since its incubation by A*STAR in 2010, MiRXES’s microRNA (miRNA) detection technology platform has progressed to become an adaptable tool in the discovery of new applications of miRNA for research and development and disease diagnosis.

Its commitment to the advancement of miRNA technology for biotech applications to solve real-world problems was also exemplified during the recent co-organization of the inaugural non-coding RNA symposium held in January 2020. The symposium brought together international experts of the field to present research in miRNA-based diagnostics and therapeutics. The symposium also saw key players in academia and industry discuss the use of miRNA technology in addressing healthcare issues and draft a Working Group for miRNA standards.

MiRXES’s technology platform was built upon the work of lead researchers Dr Zhou Lihan, Dr Zou Ruiyang, and Associate Professor Too Heng-Phon from the National University of Singapore’s Medical School whose research on miRNA was first published back in 2005.

Out of all the methods of nucleic acid detection, MiRXES uses Polymerase Chain Reaction (PCR) as the basis of measuring almost any miRNA in biological samples.

“When we first started, we did a conscious choice of going towards PCR, but not array or sequencing. PCR is by far the most sensitive and robust technology for miRNA which is extremely short.” Shared Dr Zhou.

“The unique point and challenge of microRNA is that it is the smallest nucleic acid you will ever find. Although it is a nucleic acid, its testing method is entirely different from almost all of the other longer nucleic acids.” Dr Zhou added. He then explained that MiRXES has developed a qPCR (quantitative Polymerase Chain Reaction) technology that is unique to miRNA. Currently there are only four unique methods of which one of them is owned by MiRXES.

Applications of MiRXES Technology Platform

MiRXES empowers both research and development and health care by tapping on its miRNA technology platform.

Through its technology, MiRXES has discovered the use of miRNA biology and biomarkers for applications in disease diagnosis and other biotech uses.

MiRXES provides scientists with the end-to-end capabilities: full technology ecosystems for biotech innovation. From sample collection to validation and functional study, it is able to deliver a suite of resources and solutions for researchers to bring their innovations to commercialization.

• GASTROClear – Early Detection for Gastric Cancer

Upon receiving regulatory approval by the Singapore Health Science Authority (HSA) in 2019, it is the first miRNA-based blood test for early detection of gastric cancer commercially available. Its development involved the collaboration of researchers and clinicians from the National University Hospital of Singapore (NUH), Tan Tock Seng Hospital, A*STAR’s DxD Hub and the Bioprocessing Technology Institute.

The diagnostic kit includes 12 selected miRNA biomarkers that is found to be associated with gastric cancer.

Dr Zhou explains that there are three layers of IP to the technology used in GASTROClear.

“There are three layers of IP, which first includes the technology that allows us to measure miRNA. Second would be the identity of the 12 miRNA biomarkers which were discovered to be associated with gastric cancer. Lastly, the final kit, in terms of how everything is packaged that can be used by almost any trained molecular biologist.” Said Dr Zhou.

“It’s based on one unique detection technology being paired with biomarkers and the unique way of how this kit is designed enables a robust workflow at the clinical level.”

CT (cycle threshold) values from the PCR results are converted using an algorithm to generate a patient’s risk score for gastric cancer. This algorithm was developed through empirical study to compare miRNA expression levels of gastric cancer patients to healthy individuals. GASTROClear’s validation of performance was through a prospective clinical study across more than 5,000 subjects in Singapore. In that sample the disease average and healthy average is identified to come up with a particular score to produce a linear equation. Each miRNA would then have a different weightage in the equation.

Through MiRXES’s GASTROClear kit screening for gastric cancer would be through a blood test. Which is less invasive and cost a fraction compared to other methods such as endoscopy.

On 18th May 2019, MiRXES provided free screening of gastric cancer through using the GASTROClear diagnostic kit to a total of 280 senior citizens in Ang Mo Kio GRC and Sengkang West SMC.1 The test is currently available for order through the Molecular Diagnostic Laboratory at Tan Tock Seng Hospital and their appointed distributor, Innovative Diagnostics Pte Ltd.

• Diagnostic Kits for COVID-192

Contributing their efforts in the fight against the outbreak of COVID-19 that started in December 2019 in Wuhan, China, MiRXES took the lead in mass-production of SARS-CoV-2 diagnostic kits. Initially manufactured by the Diagnostics Development (DxD) Hub, the license was passed on to MiRXES on the 14th February 2020 which grants the rights to manufacture and commercialise the diagnostic kit. Leveraging on its manufacturing expertise and commercial positioning, MiRXES was able to produce 100,000 kits within a week with its capacity.

The diagnostic kit was a result of the work of researchers at A*STAR and Tan Tock Seng Hospital which also received approval by the Health Sciences Authority (HSA). This kit uses PCR technology to detect the presence of SARS-CoV-2 providing accurate the rapid results. 10,000 of these kits together with PCR machines were sent to China by the Singapore Government in February 2020.

Challenges to Overcome

Dr Zhou highlighted three main challenges in the process of getting the miRNA technology in working order.

The first was the most technical and basic, which was getting the technology to work. Another challenge was understanding the biology behind miRNA which, a decade ago when the team started working in miRNA very little information was available. Many doubts on the viability of miRNA targets and the uncertainty as the biology of miRNA was still being proven. Having invested in working on preclinical system models of cell lines, which then moved on to animal models progressed on to human clinical samples, the team took a step-by-step approach to prove the viability and credibility of miRNA technology. During this long process, a lot more research on miRNA was emerging globally, this worked in favour for the team.

“Most academic physicians, don’t have any more doubts about the relevance of microRNA.” Said Dr Zhou.

Lastly, the third challenge was building the individual capabilities, which include Research and Development, Key Developmental capabilities, and Manufacturing. After the formation of these capabilities the next step for MiRXES was the need to educate the market of this novel technology.

Dr Zhou added, “we had to solve these challenges one at a time. After the first challenge we would see there’s something interesting. Then the next challenge was convincing the professionals in the field that it is credible. The next challenge would be educating the public, especially the elderly, that they should do the blood test [for cancer detection].”

What’s Next for MiRXES?

MiRXES is on track to profile 200,000 miRNA clinical samples within the next five years, this curated database aims to study 30 disease areas mainly in oncology, cardiovascular disease and metabolic diseases.

“To date we have collected about 50,000 samples across 20 different disease areas, with a high throughput and manufacturing capability that we have built, we could measure 200,000 samples within a year.” Shared Dr Zhou.

“But why we are going to take five years is that we want each of these measurements to matter.” He adds. Picking the right case patients and control subjects is essential when answering such scientific clinical questions. Dr Zhou also explains that proper clinical follow up and essential clinical information correlating to the measurements are required.

In 2020, MiRXES will be venturing into Japan and broadening their presence in the United States. Dr Zhou shares that they will be expanding to selected European markets and looking into an opportunity in Africa.

MiRXES will be looking to launch screening tests for breast cancer and lung cancer in 2020.

This interview was conducted by Deborah Seah
Photo Credits: MiRXES Pte Ltd

References

  1. Seow. J. The Straits Times (2019, May 18) Seniors get tested for stomach cancer at free screening in Teck Ghee. Retrieved from: https://www.straitstimes.com/singapore/seniors- get-tested-for-stomach-cancer-at-free-screening-in-teck-ghee
  2. EDB Singapore. (2020, February 18) Local SME to mass-produce SARS-CoV-2 diagnostic test kits. Retrieved from: https://www.edb.gov.sg/en/news-and-events/insights/innovation/local-sme-to-mass-produce-sars-cov-2-diagnostic-test-kits.html?cid=soc-li-insights_localsmeproducecovidtestkit-bau-cotnt-202002-sg-si%3Apb%3Abn%3Aid%3Aat%3Ana%3Asn&utm_medium=soc&utm_source=linkedin&utm_campaign=bau_edb_content_insights_localsmeproducecovidtestkit_singapore_ 202002&utm_content=stockimages-pharmaceutical&biotechnology-businessnews-innovation&digitalization-article-notapplicable-syndicated-nc


Dr Zhou Lihan, Co-Founder, CEO, MiRXES Pte Ltd

Dr Zhou co-founded MiRXES in 2014 focusing on the development of microRNA research and technologies for translation to real-world applications. He oversees the company’s direction and goals from MiRXES’s global headquarters in Singapore.

Prior to the founding of MiRXES, Dr Zhou was a research scientist at the Bioprocessing Technology Institute (BTI) in A*STAR where he co-developed a novel microRNA qPCR assay platform capable of robustly detecting microRNA from small amounts of clinical specimens. He was also a core member in creating an integrated workflow for biomarker discovery

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