Singapore biotechnology company Mirxes started life in a research lab, running on notebooks and Excel sheets. Bringing a cancer-detection blood test to market meant leaving all of that behind.<\/p>\n
\u201cWe went from lab notebooks and Excel sheets to documented and official forms and records,\u201d says Jonathan Ho, associate director of quality assurance at Mirxes. That shift \u2013 to ISO 13485, an international standard for medical device quality management \u2013 would become the foundation the company built its processes on.<\/p>\n
The company\u2019s roots trace back to the early 2000s, when scientists at A*STAR developed a method to detect microRNA, genetic markers that can detect cancer \u2013 including at early stages \u2013 from a simple blood draw, stratifying individuals into low-, intermediate- or high-risk categories to guide physicians on appropriate follow-up, including gastroscopy, where warranted.<\/p>\n
After the technology was patented in 2010, Mirxes was spun out of A*STAR in 2014 to bring it to market.<\/p>\n
That commercial journey demanded consistency, regardless of when, where or by whom a test was performed. Certification took about a year and required stress-testing variables most would not think of: shipments sitting for hours on airport tarmacs, temperature fluctuations across the supply chain, intricacies at the molecular level that could not be missed.<\/p>\n
\u201cWhen dealing with the detection of gastric or lung cancer, there are a lot of intricacies at the molecular level that we cannot afford to miss out, because once we miss something or make one wrong move, it could result in a misdiagnosis and emotional anguish for patients,\u201d says Ho.<\/p>\n GASTROClear, the cancer detection blood test that Mirxes was able to bring to market faster by building on the quality standards infrastructure it had already put in place.<\/p>\n PHOTO: MIRXES<\/p>\n<\/figcaption><\/figure>\n Commercialising the technology meant moving beyond the flexibility of research environments towards tightly standardised processes.<\/p>\n \u201cWe managed to successfully change this mindset by explaining to our team why we had to make changes. For example, for traceability in documents and records,\u201d says Ho. \u201cThat\u2019s where the importance of adhering to standards comes in.\u201d<\/p>\n<\/picture><\/div>