Pioneering Biotechnology Firm Mirxes Set To Ride The Precision Medicine Wave With Its microRNA Technologies

With its proprietary microRNA (miRNA) technologies for early disease detection, home-grown biotechnology company Mirxes is well-positioned for an era of transformative healthcare.

Precision medicine, which uses information from a person’s genes or proteins to prevent, diagnose or treat diseases, is often regarded as the bound in healthcare by offering tailored solutions to individual health needs.

In the early 2000s, A*STAR scientists Professor Too Heng-Phon, Dr Zhou Lihan and Dr Zou Ruiyang pioneered a highly sensitive, specific and robust detection technology for microRNA, the smallest genetic material ever found in human and other living organisms. Recognising its potential to combat cancer, cardiovascular, metabolic, and infectious diseases, they, with the support of A*STAR’s Bioprocessing Technology Institute (BTI), decided to bring the technology from lab bench to clinic.

Mirxes was incorporated in 2014, and as its name implies, is built around miRNA technologies for the expression of genes. The team set to work developing accurate multi-cancer early detection solutions with a special focus on gastrointestinal cancer.

Achievements by Mirxes to date

The Opportunity

Why did we choose to spin off in 2014? Two main reasons: Firstly, the technology had reached a maturity where it can be applied. Secondly, there was sufficient evidence in the scientific arena that RNA, specifically MiRNA, had the potential to detect diseases such as cancer early. We could have continued to carry on with the research, but that would not have captured its commercial value and advanced the technology faster.

Zhou Lihan, CEO and co-founder of Mirxes

Getting a fledgling company with novel technology in a nascent field off the ground was no easy feat, however. As Dr Zhou noted, Mirxes did not raise any money until 2016. They kept afloat operating on its own founders’ money, revenue from providing the technology to biopharmaceutical companies, as well as grants from Enterprise Singapore, before private venture capitalist group Venturecraft eventually seed-funded it.

DPM Gan Kim Yong, and Minister for Trade and Industry, with Dr Zhou Lihan at A*STAR Advance Remanufacturing Lab in 2022

Partnering With A*star To Deliver World-class Biomed Solutions

In the early days, Mirxes drew on the close ties with A*STAR’s research institutes to work on a pipeline of biomedical products. For its first product, the team targeted stomach cancer as it was the fourth most common cancer globally, and especially prevalent in Asia.

The outcome was GASTROClear, which took seven years to develop, the world’s first microRNA blood test for early gastric cancer detection with a high sensitivity rate of 89%.

With GASTROClear’s success, the company forged ahead with the development of non-invasive screening tests for the early detection of six major cancers, including lung, liver, breast and colorectal cancer, as well as for various infectious, cardiovascular and metabolic diseases. In July 2022, Mirxes launched Project CADENCE (CAncer Detected Early caN be CurEd), the world’s first large-scale clinical research project for the discovery and validation of novel combinations blood-borne circulating miRNA and DNA methylation biomarkers that will lead to the development of a multi-cancer early detection test for up to nine high incidence and high mortality cancers, namely lung, breast, colorectal, liver, stomach (gastric), esophageal, ovarian, pancreatic, and prostate cancers.

Partnering Mirxes on its product developmental journey were various A*STAR institutes, such as the Diagnostics Development Hub (DxD Hub). GASTROClear was the result of a joint lab collaboration with DxD Hub, as well as participation from other Singapore healthcare institutions. In this collaboration, DxD Hub was also instrumental in helping the company secure regulatory approval from Singapore’s Health Sciences Authority (HSA) in 2019.

Mirxes went on to partner with more A*STAR institutes, such as BTI, the Institute of Molecular and Cell Biology (IMCB), the Singapore Immunology Network (SIgN), as well as the Experimental Drug Development Centre (EDDC), a national platform hosted by A*STAR, through a series of Research Collaboration Agreements (RCA) to develop the later suite of clinical diagnostics tests.

Second Minister for Trade and Industry, Dr Tan See Leng at the launch of the Mirxes – A*STAR joint lab in 2024

In 2024, Mirxes and A*STAR also announced the opening of their joint lab to co-develop and deliver a solution that can be reconfigured and scaled for IVD manufacturing, and with the potential to reinforce both local and global MedTech diagnostic value chains.

As Dr Zhou described the relationship, “Our collaboration with A*STAR rested on three main pillars: first, the development of novel technologies; second, a symbiotic exchange of talent; and third, the brand recognition of having A*STAR as a partner. Many staff in Mirxes came from A*STAR and vice versa. Our close association with A*STAR is a signal to our investors, customers and partners that Mirxes is trusted partner that delivers quality.”

A Window Of Opportunity In A Pandemic

The COVID-19 pandemic in 2020 proved to be a real litmus test of Mirxes’ robust partnership with A*STAR.

One of Singapore’s key strategies was to ensure strong testing capability to contain the spread of the virus, as large-scale testing allowed for early detection and isolation of cases before infections spread. Close collaboration between Mirxes, A*STAR and the public health community enabled Fortitude, a COVID-19 PCR diagnostic test kit, to be quickly developed and deployed in Singapore hospitals to detect the SARS-CoV-2 virus that causes COVID-19.

Working around the logistical challenges and pandemic-related restrictions, Mirxes and A*STAR came together to manufacture, obtain regulatory approval and deliver 10,000 sets of Fortitude, in a compressed timeline of just two weeks.

The team quickly repurposed production lines to manufacture 100,000 tests per week by March 2020, and was producing one million tests every week by mid-2020, with Fortitude reaching the shores of over 40 countries worldwide.

The trust that was built working on GASTROClear was the reason that everybody could naturally come together to work on Fortitude. A*STAR was already familiar with our manufacturing processes while we understood A*STAR’s ecosystem and processes, so everything flowed very smoothly.

Dr Zhou Lihan, CEO and co-founder of Mirxes

The A*STAR Innovation Offerings Mirxes Has Tapped On

Joint Research Programmes : R&D collaborations between a private company with A*STAR research institutes (RIs) that help to enhance the technology edge of the company by the technology transfer from the RIs.

Expanding Its Regional & Global Footprint

Having cemented its stake in the cancer and infectious diseases space, Mirxes is now geared to enter into precision medicine, where promising new therapies are built on next generation technologies and drug discoveries.

However, as Dr Zhou noted, “Although the company had a headstart, competition has intensified ever since everyone realised the huge potential of RNA. There's no way Singapore can compete with the US or China in terms of sheer volume of investment into R&D. Rather, we must be selective – in carving out a space for ourselves in ASEAN, and in leveraging opportunities amidst the US-China trade tensions.”

As it enters its growth phase, Mirxes has seen its revenue exceed $60 million and its headcount expand to over 300 locally and globally. With R&D labs, manufacturing and clinical testing facilities in Singapore and China and sales offices in the US and Japan, the company is now growing its presence in the Southeast Asia markets of Malaysia, Vietnam, Philippines and Indonesia. Also in the works are collaborations with partners such as Johnson & Johnson (J&J) and Harvard Medical School on the world’s largest lung cancer microRNA liquid biopsy study, with the aim to develop lung cancer diagnostics.

The most pressing challenge, as it turns out, is talent.

Said Dr Zhou, “Most of the talents in this field reside either in the US or more recently, China. As a company that is firmly anchored in Singapore, Mirxes needs talents who can understand the commercial needs of the global markets and the region in order to operate in them. We are not just competing with the biotech industry for talents but with tech companies like Grab and SEA.”

As much as we try, we can’t nurture talent fast enough. And we can’t afford to wait because the opportunity doesn't wait.

Dr Zhou Lihan, CEO and co-founder of Mirxes