From Singapore to the world

Founded with a focus on microRNA discoveries and diagnostics, MiRXES is now looking to solidify its manufacturing and delivery capabilities and help Singapore elevate its competitiveness on the global stage.

Starting out as a small country with no natural resources, Singapore has since evolved into a world-class advanced manufacturing hub in just half a century. These days, manufacturing makes up about 20 percent of the country’s GDP and employs over 400,000 people.

As the fourth largest global exporter of high tech products, many of the biggest names in industry like Siemens and HP have found a second home in Singapore. But homegrown companies like MiRXES are eager to take the country’s manufacturing capabilities to the next level. MiRXES, for instance, is responsible for producing a million COVID-19 test kits a week, with a significant number being exported to over 40 countries worldwide.

That’s not too shabby for a company that began only in 2014 with no manufacturing capacity to speak of. Though various naysayers advised the company’s founders against starting its own manufacturing arm—citing a lack of demand from a relatively small domestic market—going into manufacturing eventually proved to be the correct move for MiRXES. In the first article of this two-part series, we trace MiRXES’ journey through three significant inflexion points over the years: quality, scale and variety.

Quality, then quantity

MiRXES’ story begins in 2010 with researchers at the National University of Singapore (NUS) developing a method to detect single-stranded genetic material known as microRNA in blood. These blood-based microRNAs play an important role in cellular pathways, hence, the slightest aberrations could indicate a far more sinister condition, like cancer.

In light of the vast potential of the technology, the Agency for Science, Technology and Research (A*STAR) supported the research group, which included MiRXES co-founders Drs Too Heng-Phon, Zhou Lihan, Zou Ruiyang and Sarah Ho, as they worked towards establishing the use of blood-based microRNAs as potential disease markers. Soon enough, the team conclusively demonstrated proof of concept that their technology could detect blood-based microRNA with unparalleled sensitivity, meaning that it could potentially be used to diagnose early-stage cancer even before the onset of symptoms. To bring this technology to fruition and save millions of lives, MiRXES was spun off from A*STAR in 2014.

MiRXES co-founders (L to R): Zhou Lihan, Zou Ruiyang, and Too Heng-Phon.

Similar to other fledgling companies at the beginning of their journey, MiRXES started with a three-person team and a singular goal: to create a quality diagnostic product. Initially focusing on a test for stomach or gastric cancer, the team needed a validated manufacturing process with a stringent quality management system. To achieve this, the MiRXES team had to first define a simple manufacturing process and invest time in understanding the science behind the product they hoped to realize. This was already a step out of the ordinary; typically, manufacturers focus on the process instead of the science behind the product.

Over the next few years, the team concentrated on developing diagnostic product lines—expanding to other indications such as lung and breast cancer—as well as building capabilities in logistics, production, quality assurance, quality control and even regulatory affairs. They also started to establish research collaborations with leading academic institutions and pharmaceutical companies, including the National Cancer Centre Singapore, Harvard Medical School and Johnson & Johnson. 

In 2015, MiRXES set up shop at the JTC MedTech Park at Tukang Innovation Grove, Singapore’s first dedicated hub for the medical technology industry. With their manufacturing process in place, MiRXES then embarked on the next stage: scaling up production while maintaining quality.

Broadening horizons

However, producing at scale required a near-complete overhaul of the entire manufacturing process. Just like their earliest days, the team had to once more study closely the science underlying the larger-scale processes they were now working with and ensure the consistency of their diagnostic tests. But MiRXES’ products weren’t the only ones scaling up and diversifying—the team was also growing, with other scientists, operations managers and engineers joining the company.

In May 2019, MiRXES’ initial ambitions were realized with the launch of GASTROClear, the world’s first RNA blood test for the early detection of gastric cancer, developed in collaboration with the Singapore Gastric Cancer Consortium and Diagnostics Development Hub (DxD Hub). Years of investing in developing a variety of products are also now bearing fruit—currently, the company has five other tests for early cancer detection in the pipeline, and even tests for infectious, cardiovascular and metabolic diseases. Building upon their expertise in microRNA, MiRXES has also launched microRNA panels that address a wide range of research goals.

It was at this stage of growth that the coronavirus pandemic struck. Fortunately, MiRXES’ Singapore-based manufacturing facility and their expertise in working with RNA made the company the ideal candidate for scaling up the production of the Fortitude diagnostic kit developed by A*STAR and Tan Tock Seng Hospital. In February 2020, MiRXES was granted the license to manufacture and commercialize the Fortitude Kit by A*STAR’s commercialization arm, A*ccelerate.

By March, the company was producing 100,000 tests a week. Now, they’ve scaled up to a million and are flying Singapore’s flag internationally by shipping the kit worldwide. In the second part of the series, learn about how MiRXES made this possible, their plans for embracing Industry 4.0 and their role in elevating Singapore’s biotechnology ecosystem.

MiRXES Fortitude Kit SARS-Cov-2 RT-PCR test used in over 40 countries worldwide for COVID-19 detection.