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.\n\n\n\nThe 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.\n\n\n\nDr. 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.\n\n\n\n\u201cLaunching this facility will empower MiRXES to further our ambitions as a global leading RNA technology innovator and cancer early detection test developer,\u201d Lihan said. \n\n\n\n\u201cThis first-of-its kind facility in Southeast Asia will equip MiRXES to address the next big challenge in healthcare \u2013 cancer, and stay prepared should we need to combat another epidemic.\u201d\n\n\n\nThe facility\u2019s 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.\n\n\n\nCollaboration with partners\n\n\n\nAt the opening ceremony, MiRXES signed a memorandum of understanding (MoU) with Singapore\u2019s Agency for Science, Technology, and Research\u2019s (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.\n\n\n\nMiRXES 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. \n\n\n\nIn 2019, MiRXES launched GASTROClear, the world\u2019s first microRNA blood test for early detection of gastric cancer. The MiRXES\u2019s multi-cancer early detection pipeline includes screening tests for lung, colorectal, liver, and breast cancer. \n\n\n\nIn 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\u2019s first authorized COVID-19 RT-PCR test. Since February 2020, more than 8 million Fortitude Kits have been deployed globally.