MiRXES opens Southeast Asia’s first industry 4.0 IVD manufacturing facility


Singapore biotech firm MiRXES Pte Ltd, which focuses on early detection cancer tests, has opened the first industry 4.0 (i4.0) in vitro diagnostic (IVD) manufacturing facility in Southeast Asia.

The S$8M (US$5.8M) 15,000-square-feet facility is located at JTC MedTech Hub. The company said the site is close to the biomedical R&D community at Biopolis, pharmaceutical companies at Tuas Biomedical Park, and the Jurong Innovation District, allowing for more partnerships to be fostered.

Dr. ZHOU Lihan, co-founder and CEO of MiRXES said the facility will allow the company to advance its IVD pipeline and manufacturing capabilities as the company works on multi cancer early detection tests, pulmonary and cardiovascular disease tests, as well as its life sciences and infectious disease portfolio.

“Launching this facility will empower MiRXES to further our ambitions as a global leading RNA technology innovator and cancer early detection test developer,” Lihan said. 

“This first-of-its kind facility in Southeast Asia will equip MiRXES to address the next big challenge in healthcare – cancer, and stay prepared should we need to combat another epidemic.”

The facility’s infrastructure uses a plug-and-play system, so it can accommodate new technologies to support functions across the production line, including prototyping, validation and manufacturing of novel IVD tests and life-sciences research. The facility can add up to five in-parallel production lines, which would triple capacity and output within each product line.

Collaboration with partners

At the opening ceremony, MiRXES signed a memorandum of understanding (MoU) with Singapore’s Agency for Science, Technology, and Research’s (A*STAR) Advanced Remanufacturing and Technology Centre (ARTC). Through the MOU, MiRXES and ARTC will scope R&D activities in automation, digitalization, disruption analysis and prevention, and sustainability.

MiRXES was founded in 2014 as a spin-off from A*STAR, with support from the National University of Singapore (NUS). The company has operations in China, Japan and the U.S. as well as commercial activities in more than 45 countries globally. 

In 2019, MiRXES launched GASTROClear, the world’s first microRNA blood test for early detection of gastric cancer. The MiRXES’s multi-cancer early detection pipeline includes screening tests for lung, colorectal, liver, and breast cancer. 

In response to the COVID-19 pandemic in 2020, MiRXES worked with A*STAR, Diagnostics Development Hub and Tan Tock Seng Hospital to mass produce Fortitude Kit, Singapore’s first authorized COVID-19 RT-PCR test. Since February 2020, more than 8 million Fortitude Kits have been deployed globally.

Main photo: MiRXES

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