Working group for MiRNA-based diagnostic standards established in Singapore

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.
By Dean Koh
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Above: Screengrab of the MiRXES website.

MicroRNA (MiRNA) is a small RNA molecule that play a central part in the functioning of the human body and are promising markers for identifying the early-stage risk of diseases such as cancer. According to an article published in Clinical Epigenetics in 2018, the differential expression of circulating miRNAs exhibited promising potential for cancer screening without additional injury for patients. The abnormal levels of distinct miRNAs could be observed at an early stage, during progression, and after metastasis of cancers.

With the aim of accelerating the development of new miRNA-based diagnostics by ensuring the reliability of products through standardization, the Working Group for miRNA standards was set up by the Singapore Standards Council (SSC) on January 7 this year. The SSC facilitates the development, promotion and review of Standards and Technical References in Singapore, particularly in nascent or emerging novel technologies. 

The Working Group comprises representatives from MiRXES, a Singapore-based biotech start-up in miRNA technology and diagnostics, Diagnostics Development (DxD) Hub of the Agency for Science, Technology and Research (A*STAR), Health Sciences Authority (HSA), academia, industrial, and clinical sectors.

WHY IT MATTERS

The Working Group will 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.

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. GASTROClear was co-developed by MiRXES, DxD Hub, and the Singapore Gastric Cancer Consortium.

RELATED DEVELOPMENTS

Ark, a holding company of MiRXES and VentureCraft which focuses on early cancer detection, raised $40M in Series A funding back in December 2018, MobiHealthNews reported

ON THE RECORD

“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 commercialization 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 in a statement. 

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