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.