From Lab to Lives: The Mirxes Journey
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2014
Mirxes Pte Ltd spun-off from A*STAR Bioprocessing Technology Institute, received TECS grant from Spring Singapore.
Formed strategic partnership with the Singapore Diagnostic Development Hub (DxD Hub) to translate miRNA cancer early detection tests.
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2015
Launched ID3EAL suite of miRNA discovery tools and services for biopharma and life science research in United States and Europe.
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2016Established ISO13485 compliant In Vitro Diagnostic manufacturing site in Singapore.
Initiated large-scale prospective clinical validation of GASTROClear in a 5000-patient high risk cohort.
Entered Chinese market with a R&D laboratory in Hangzhou.
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2017Obtained CE registration for GASTROClear.
Initiated global collaborations in oncology, cardiovascular, metabolic diseases.
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2018Established global partnerships with Johnson & Johnson, and other multi-national biopharma companies.
Set up joint R&D labs with Beth Israel Deaconess Medical Center, Boston, USA, and the National University of Singapore.
Set up US office for US market expansion.
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2019Flagship IVD product, GASTROClear, received regulatory approval in Singapore for gastric cancer early detection.
Established ISO13485 compliant IVD manufacturing site in Hangzhou China.
Established clinical diagnostic laboratory in Tianjin, China.
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2020Set up Japan office for Japan market entry.
Contributed to world's 1st industry standard of miRNA-based diagnostics.
Mass produced Singapore's 1st approved COVID-19 PCR test kit and deployed to approximately 35 countries during the pandemic.
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2021Launched M Diagnostics clinical laboratory to provide specialty clinical testing to Southeast Asia.
Raised USD$87M Series C; total of USD$130M secured since inception - largest funding to date raised by a Singapore-headquartered cancer diagnostics company.
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2022Established Southeast Asia’s largest industry 4.0 IVD manufacturing facility in Singapore.
Launched Project CADENCE, the world’s first research project for a multi-cancer (up to nine high incidence and high mortality cancers) early detection test.
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2023Received US FDA’s Breakthrough Device Designation for GASTROClearTM.
Secured USD$50M Series D, as the company filed for IPO at the Hong Kong Stock Exchange.
Completed China registrational trial for GASTROClearTM (n=9,472).
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2024Opened DMOC@Biopolis, Singapore’s pioneering public-private partnership centre for specialty molecular testing, with NUH.
Scored first business grant from the Japan External Trade Organization (JETRO) to develop novel cancer screening tests in Japan.
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2025Listed on the Main Board of HKEX; raised HKD$1.09B and became SEA’s first biotech unicorn.
Included as a constituent of Hang Seng Composite Index, thereby qualifying for Southbound Stock Connect.
GASTROClear granted regulatory approval by China’s NMPA, becoming the first blood test approved for gastric cancer screening in China.
– Mirxes Pte Ltd spun-off from A*STAR Bioprocessing Technology Institute, received TECS grant from Spring Singapore.
– Formed strategic partnership with the Singapore Diagnostic Development Hub (DxD Hub) to translate miRNA cancer early detection tests.
– Launched ID3EAL suite of miRNA discovery tools and services for biopharma and life science research in United States and Europe.
– Established ISO13485 compliant In Vitro Diagnostic manufacturing site in Singapore.
– Initiated large-scale prospective clinical validation of GASTROClear in a 5000-patient high risk cohort.
– Entered Chinese market with a R&D laboratory in Hangzhou.
– Obtained CE registration for GASTROClear.
– Initiated global collaborations in oncology, cardiovascular, metabolic diseases.
– Established global partnerships with Johnson & Johnson, and other multi-national biopharma companies.
– Set up joint R&D labs with Beth Israel Deaconess Medical Center, Boston, USA, and the National University of Singapore.
– Set up US office for US market expansion.
– Flagship IVD product, GASTROClear, received regulatory approval in Singapore for gastric cancer early detection.
– Established ISO13485 compliant IVD manufacturing site in Hangzhou China.
– Established clinical diagnostic laboratory in Tianjin, China.
– Set up Japan office for Japan market entry.
– Contributed to world’s 1st industry standard of miRNA-based diagnostics.
– Mass produced Singapore’s 1st approved COVID-19 PCR test kit and deployed to approximately 35 countries during the pandemic.
– Launched M Diagnostics clinical laboratory to provide specialty clinical testing to Southeast Asia.
– Raised USD$87M Series C; total of USD$130M secured since inception – largest funding to date raised by a Singapore-headquartered cancer diagnostics company.
– Established Southeast Asia’s largest industry 4.0 IVD manufacturing facility in Singapore.
– Launched Project CADENCE, the world’s first research project for a multi-cancer (up to nine high incidence and high mortality cancers) early detection test.
– Received US FDA’s Breakthrough Device Designation for GASTROClearTM.
– Secured USD$50M Series D, as the company filed for IPO at the Hong Kong Stock Exchange.
– Completed China registrational trial for GASTROClearTM (n=9,472).
– Opened DMOC@Biopolis, Singapore’s pioneering public-private partnership centre for specialty molecular testing, with NUH.
– Scored first business grant from the Japan External Trade Organization (JETRO) to develop novel cancer screening tests in Japan.
– Listed on the Main Board of HKEX; raised HKD$1.09B and became SEA’s first biotech unicorn.
– Included as a constituent of Hang Seng Composite Index, thereby qualifying for Southbound Stock Connect.
– GASTROClear granted regulatory approval by China’s NMPA, becoming the first blood test approved for gastric cancer screening in China.
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