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Singapore Leads in Translating MicroRNA Research Into Clinical Applications That Will Improve Healthcare and Save Lives

Translating MicroRNA Research Into Clinical Applications

Singaporean biotech start-up MiRXES, National University of Singapore (NUS) and Diagnostics Development (DxD) Hub of the Agency for Science, Technology and Research (A*STAR) are leading three initiatives to position Singapore as a global leader in translating microRNA research into clinical applications that will improve healthcare and save lives.

They held meetings in January 2020 to discuss paving the way for more reliable clinical validation and greater industry adoption of miRNA-based diagnostics, both nationally and globally. These initiatives also place Singapore at the forefront of translating miRNA research into new diagnostic applications that will improve disease diagnosis and treatment outcomes globally.

MiRXES is a leading Singaporean biotech start-up in microRNA (miRNA) technology and diagnostics, which have collaborated with NUS and DxD Hub to mark the tenth year of miRNA research and clinical translation in Singapore.

These organisations jointly led a non-coding RNA (ncRNA) Symposium to advance research in miRNA and other ncRNAs, a ncRNA Roundtable to chart a strategy for miRNA clinical translation globally, and Working Group for miRNA standards that will provide the world’s first national (Singapore) standard for miRNA-based diagnostics by this year.

The industry-leading miRNA detection technology has been applied by MiRXES globally to study and develop diagnostic applications for more than 30 different diseases, including more than 10 different cancer types, heart disease, and diabetes.

MiRXES is on track to complete the world’s largest miRNA expression database from 200,000 clinical samples across 30 types of diseases in the next five years.

MiRXES Pte Ltd based in Singapore, was founded in 2014 by a team of scientists who aimed to translate their research into affordable blood tests that can detect cancer early, with the goal of eventually eradicating late-stage cancer.

Led by researchers Dr Zhou Lihan, Dr Zou Ruiyang, and Associate Professor Too Heng-Phon from the National University of Singapore’s (NUS) Medical School, the team developed a technology that was able to reliably and sensitively detect microRNAs, one of the smallest and most recently discovered types of genetic material known to scientists.

This research that began in an academic lab in 2010 was then incubated under Singapore’s Agency for Science, Technology and Research (A*STAR) to birth MiRXES’ microRNA technology platform. MiRXES was spun off from A*STAR in 2014 to commercialize and apply this core technology, with the initial focus of developing affordable tools for disease diagnosis.

“We’re proud of the progress that the biomedical industry and homegrown enterprises such as MiRXES have made in the field of miRNA research. We look forward to more public-private partnerships that will accelerate the development of new diagnostics to establish Singapore as a global hub for diagnostic innovation and development, and address the burden of unmet clinical needs,” said Dr. Yee, CEO of DxD Hub.

Developing Standards for miRNA-based Diagnostic Products

One key to accelerating the development of new miRNA-based diagnostics is to ensure the reliability of products through standardization. This is the aim of the Working Group for miRNA standards set up by the Singapore Standards Council.

The Working Group comprises representatives from MiRXES, DxD Hub, Health Sciences Authority (HSA), academia, industrial, and clinical sectors.

The group gathered in January 2020 to draft the world’s first national standard for validation of miRNA-based diagnostics, putting it on-track for approvals and publication this year. The miRNA standard will include specifications and procedures that make it easier for users and regulators to understand and compare competing miRNA-based diagnostic products.

“The development of this standard will ensure quality consistency in the collection, handling and isolation of miRNAs from human samples. This will facilitate greater regulatory approval, boost patients’ confidence in diagnostics accuracy and enable quicker access to treatment for chronic diseases.”

“Companies can use this standard to develop new test kits for diseases, such as cancers, based on miRNA techniques. We will work with industry stakeholders and regulators to support greater innovation and commercialisation of new products and services in the biomedical sector,” said Dr. Yong Chern Chet, Chair of the Biomedical and Health Standards Committee, Singapore Standards Council.

Singapore Forefront of the Global MiRNA Industry

Homegrown biotech firms such as MiRXES are making great strides in elevating Singapore to the forefront of the global miRNA industry thanks to support from regulatory authorities.

Singapore achieved a world’s first in 2019 when HSA approved GASTROClear, a miRNA-based in vitro diagnostic solution for early detection of gastric cancer. As co-developer and manufacturer, MiRXES consulted HSA several times during the product development phase of GASTROClear. Early consultation with HSA enhanced MiRXES’s understanding of the regulatory requirements and facilitated the approval process.

After receiving regulatory approval from HSA for GASTROClear via the priority review pathway, MiRXES is poised to take on a leading role on the global stage in guiding innovative miRNA discoveries towards clinical validation and application.

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