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DxD Hub: World’s First miRNA-based Early Gastric Cancer Detection Test – Made Possible with SS 656
DxD Hub adopted SS 656 – the world’s first standard for the validation of miRNA-based diagnostics – in the development of GASTROClear. SS 656 describes the key considerations for the design, development and performance evaluation of miRNA-based molecular diagnostic assays.
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SS 656:2020 – Design, development and
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Organisation Profile
Diagnostics Development (DxD) Hub was established as a regional medtech innovation centre in Singapore in 2014. It develops medical devices that enable quicker diagnoses and better treatment outcomes for patients. DxD Hub is led by the Agency for Science and Technology Research (A*STAR) through its Innovation and Enterprise division (formerly known as ETPL).
Challenges and Solution
At the current rate, new cancer cases globally will increase by 47% by 20401. This creates a demand for early cancer detection tests that are quick, effective and non-invasive.
To address this need, DxD Hub collaborated with A*STAR spinoff MiRXES, as well as the Singapore Gastric Cancer Consortium, National University Hospital and Tan Tock Seng Hospital to develop GASTROClear, the world’s first blood-based microRNAs (miRNAs) test for early gastric cancer detection.
GASTROClear measures the levels of miRNAs – genetic materials found in human and other living organisms – in the blood.
Most cancers secrete abnormal levels of miRNAs into the blood. This means that miRNAs can act as useful biomarkers for early cancer detection.
GASTROClear picks up 12 miRNAs associated with gastric cancer and can detect 87% of all gastric cancers, including 87.5% of Stage 1 cancers. Conventional blood tests only have an accuracy rate that is between 50% and 60%2.
“With GASTROClear, we see that miRNA-based diagnostics have so much potential,” says Dr Dominic Phua, Principal Scientist at DxD Hub. “However, such diagnostics are a recent development in the industry, so standardisation is required to better validate them and help us continue developing similar high-quality screening tests quickly for other cancers.”
DxD Hub has adopted SS 656 – the world’s first standard for the validation of miRNA-based diagnostics – in its development of GASTROClear. SS 656 describes the key considerations for the design, development and performance evaluation of miRNA-based molecular diagnostic assays.
Benefits of Implementing SS 656
1. Meet Regulatory Requirements
For a medical device to be manufactured and supplied in Singapore, it must conform to the safety and performance principles mandated by the Health Sciences Authority (HSA).
SS 656 references HSA’s principles. By adopting SS 656 for GASTROClear, the DxD Hub project team were able to expedite HSA’s approval and offer peace of mind to clients when it came to quality control and product integrity.
Dr Phua says, “Everywhere in the world, medical devices go through rigorous regulatory processes, which can be time-consuming. Implementing SS 656 gave the confidence that the requirements could be met and the time to market shortened for miRNA-based diagnostics.”
2. Speed Up Product Development
Creating a product in a new research area usually involves much trial and error. “There is a lot of guesswork,” says Dr Phua, “yet we were able to eliminate some of that and lessen any time wasted with SS 656.”
Dr Phua describes SS 656 as “providing a formula” to designing, developing and validating GASTROClear. “It is like an equation and we fit in the different parts.”
He explains, “SS 656 works like a framework that allowed us to be very focused: from the get-go, we knew the kinds of protocols, parameters, analyses and samples needed – and which could help increase the effectiveness of our product. Being prepared in this way meant that we could also more accurately anticipate other factors like processing time and logistics, which was beneficial to operational planning.”
3. Increase Credibility and Business Partnerships
Developing a breakthrough product is just a part of the story. “The next big part is to market it,” says Dr Sidney Yee, Advisor at A*STAR’s Innovation & Enterprise Group and former CEO of DxD Hub.
SS 656, she says, adds credibility to the product development process. “SS 656 enabled the commercial partner, MiRXES, to export GASTROClear as well as to partner with multinational corporations. By conforming to a standard, we provide assurance. MiRXES is now looking into exporting GASTROClear to Germany.”
“GASTROClear is the first of its kind in the world. With SS 656, DxD Hub and MiRXES gained first-mover advantage in the field of miRNA-based diagnostics,” says Dr Yee. “We are developing more of such tests together. The possibilities of miRNA-based diagnostics are very exciting.”