From Lab to Market: Putting Diagnostics Innovations on the Fast Track

The Diagnostics Development (DxD) Hub accelerates technology translation from lab to market, to improve healthcare and develop a robust diagnostic devices ecosystem in Singapore.

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DxD Hub scientist at work in the lab

Driving Impactful Healthcare Solutions

The increasing prevalence of chronic illnesses, ageing populations and growing healthcare awareness are driving the explosive demand for diagnostics testing and medical devices in healthcare, with the global in-vitro diagnostics market projected to reach more than USD90 billion by 20251. This global trend is underscored by the ongoing COVID-19 pandemic, which has generated an urgent and unprecedented demand for new diagnostic tests.

Funded by the National Research Foundation, the DxD Hub is a national platform led by A*STAR. It aims to accelerate the speed at which local enterprises translate their R&D into market-ready diagnostic solutions.

Companies can leverage DxD Hub's expertise in regulatory navigation and dossier development, product design optimisation and verification, clinical validation, as well as production and quality management system processes, to reach the market quickly with their diagnostic products. Additionally, as a national platform, DxD Hub brings together key stakeholders such as clinicians, researchers, innovators, entrepreneurs and industry professionals, enabling companies to benefit from a cross-pollination of ideas and knowledge.

Since its inception in 2014, DxD Hub has delivered more than 25 products for the effective diagnosis and timely treatment of diseases, thus driving better health outcomes for Singaporeans and beyond. We explore some of the cutting-edge diagnostics solutions co-developed by DxD Hub.

GASTROClear: Detection of Early-Stage Gastric Cancer

The world’s first approved microRNA blood test for early detection of gastric cancer, GASTROClear was co-developed with local biotech company MiRXES. It is a minimally invasive blood-based assay that can detect 87.5% of stage I gastric cancers and 89.5% of stage II gastric cancers.

DxD Hub led in the assay optimisation, analytical verification and clinical validation of the product. The assay attained the European CE mark in 2017 and Health Sciences Authority (HSA) approval in 2019. GASTROClear is also setting the standard for microRNA-based diagnostic tests – it is used as an exemplar in the drafting of the Singapore Standard 656, the world's first national standard for the design, development and validation of microRNA-based diagnostics2.

GASTROClear is used at public hospitals such as Tan Tock Seng Hospital (TTSH) and National University Hospital (NUH), as well as several private general practitioner clinics and specialist’s clinics for the pre-screening of gastric cancer. It is currently being evaluated for use in primary care settings such as polyclinics. MiRXES is also conducting local clinical studies to seek regulatory approval of GASTROClear in China and Japan.

X-ZELL: Early Detection of Prostate Cancer

X-ZELL first made headlines in 2017 when its inventors found a way to routinely detect tumour-associated Circulating Endothelial Cells (tCEC) in small, 10mL blood samples. tCEC are strong biomarkers for the early detection of cancers and were previously considered as ‘undetectable’ in clinical routines. X-ZELL achieved this by fusing next-generation cell detection technology with cutting-edge artificial intelligence, enabling researchers to isolate and visualise a single tCEC among five billion healthy blood cells.

In 2018, the biotech company partnered DxD Hub to accelerate its capabilities and scale up its commercialisation and product development processes. X-ZELL moved the company’s global headquarters to Singapore and collaborated with DxD Hub in the productisation of its X-ZELL instruments, as well as in the standardisation and optimisation of its workflows.

Less than a year after its initial breakthrough, X-ZELL was able to present the world’s first tCEC-based blood test for the early detection of clinically significant prostate cancer – X-ZELL Prostate. The first in a series of tCEC-based liquid biopsies, X-ZELL Prostate is already approved for sale in Thailand and will be launched across the ASEAN region following the conclusion of a final, blinded validation study in Singapore. The clinical validation in Singapore is spearheaded by DxD Hub, in partnership with the NUH and SGH.

Fortitude Kit: Rapid, Accurate Detection of SARS-CoV-2

MiRXES Fortitude Kit Rapid, Accurate Detection of SARS-CoV-2
Dr Sidney Yee, CEO of DxD Hub, holding up the Fortitude Kit, with Dr Lihan Zhou, CEO of MiRXES

The Fortitude Kit detects the presence of the SARS-CoV-2 virus, which causes COVID-19, quickly and with high accuracy. It uses a real-time Reverse Transcription-Polymerase Chain Reaction (RT-PCR) laboratory technique that is considered the gold standard method for detecting the presence of pathogens.

Co-developed by DxD Hub, the Experimental Drug Development Centre (EDDC), A*STAR’s Bioinformatics Institute (BII), and the Department of Laboratory Medicine at Tan Tock Seng Hospital (TTSH), the Fortitude Kit was developed in less than a month. By February 2020, it received the Singapore Health Sciences Authority’s (HSA) Provisional Authorisation for clinical use. DxD Hub supported the optimisation, verification, validation and production of these tests.

To further fulfill local and international demand, the technology was licensed to biotech companies, such as MiRXES, to scale-up the manufacturing and distribution of the diagnostic kits. To date, more than five million Fortitude Kits have been deployed to 45 countries globally.

Resolute Kit: Expediting COVID-19 Testing

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Team from DxD Hub who worked on the Resolute kit

The Resolute kit is a breakthrough Direct-Polymerase Chain Reaction (PCR) diagnostic test kit for COVID-19, jointly developed by DSO National Laboratories (DSO) and DxD Hub. By eliminating the need for extraction of viral RNA from patient test samples, Resolute minimises potential human errors and halves the test delivery time. Conventional PCR tests take 2.5 hours or longer.

To further expedite the testing process, A*STAR’s Advanced Remanufacturing and Technology Centre (ARTC), the Singapore Institute of Manufacturing Technology (SIMTech), and the DxD Hub co-developed a robotics lab system called Rapid Automated Volume Enhancer (RAVE) that works with Resolute. The system automates some of the manual steps usually required in sample processing such as uncapping of tubes and pipetting. This saves time, manpower and costs while maintaining high accuracy and speed of testing, and mitigating the risks of staff in testing labs. The integrated Resolute and RAVE system can process a high throughput of close to 4,000 samples a day, four times the usual RT-PCR throughput.

Resolute was developed to strengthen Singapore’s fight against COVID-19. Since receiving HSA’s provisional authorisation in April 2020, It has also been cleared for use in deep throat saliva testing, making COVID-19 screening less traumatic and invasive for patients. DxD Hub has been working closely with local biotech company Advanced MedTech Holdings to accelerate the production and deployment of the tests.