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Vol 24, No. 09, September 2020   |   Issue PDF view/purchase
INSIDE INDUSTRY
Commercialisation of Direct Multiplex RT-PCR COVID-19 Diagnostic Test
Advanced MedTech Holdings is granted license and Provisional Authorisation for manufacture of COVID-19 diagnostic test kit, RESOLUTE 2.0.

Industry-first SARS-CoV-2 direct multiplex Reverse Transcription-Polymerase Chain Reaction (RT-PCR) assay kit was co-developed by Singapore’s Agency for Science Technology and Research (A*STAR) and DSO National Laboratories (DSO). Working together with the global medical technology company, Advanced MedTech (AMTH), the kit has since been made available for clinical use in Singapore.

The technology of direct multiplex RT-PCR COVID-19 diagnostic kit known as RESOLUTE 2.0 has been licensed to AMTH from A*STAR and DSO. Provisional Authorisation was also granted by Singapore’s Health Sciences Authority (HSA) for AMTH to manufacture and supply the test kit. The pilot production of the RESOLUTE test kit was conducted in close collaboration with, and validated by, the Diagnostics Development (DxD) Hub, a national platform hosted by A*STAR.

RESOLUTE 2.0 eliminates the need for extraction of viral RNA from patient test samples, thus minimising potential human errors and halving the test delivery time when compared to other approved RT-PCR kits which are considered the gold standard in SARS-CoV-2 detection. A multiplex RT-PCR, RESOLUTE 2.0 also allows for simultaneous detection of multiple SARS-CoV-2 targets and human control target in one single reaction.

Further reducing the turnover time of the testing process, A*STAR’s Advanced Remanufacturing and Technology Centre (ARTC), the Singapore Institute of Manufacturing Technology (SIMTech) and DxD Hub co-developed the complementary Rapid Automated Volume Enhancer (RAVE) robotics lab system.

This automated system was made locally in Singapore which will also be distributed by AMTH together with RESOLUTE 2.0. The automated system, RAVE, minimises the manual steps in the preparation of a test assay, shortening the time to results. Two sets of RAVE system together with thermal cyclers was able to demonstrate an output of 4,000 samples in a day.

Abel Ang, Group Chief Executive of Advanced MedTech, said, “We are proud to have worked with A*STAR, DxD Hub, DSO National Laboratories and other agencies to rapidly bring world-class multidisciplinary research done in Singapore to the global stage.”

“The speed, accuracy, and scale of the combined RESOLUTE 2.0 test kit and RAVE automation will make it an indispensable part of the overall toolkit of leading COVID-19 testing centres around the world. I am proud of how our team was able to complete technology transfer and scale up our manufacturing capability in a matter of weeks.” He added.

In its effort to ramp up COVID-19 testing capabilities in Singapore, AMTH set up one of the largest automated in-vitro diagnostics manufacturing facilities within six weeks. The manufacturing site is currently fully operational and able to boost production up to two million test per month.

With the support of DxD Hub, AMTH intends to file for regulatory approval for the RESOLUTE 2.0 test with the United States FDA and will file additional regulatory submissions around the world.

Mr Frederick Chew, Chief Executive Officer, A*STAR, said, “This cutting-edge diagnostics innovation is a result of triple-helix public-private collaboration between A*STAR, DSO and Advanced MedTech. The integrated RESOLUTE 2.0 and RAVE system combines strong engineering capabilities with deep biomedical science to create value. Separately, the range of COVID-19 technology innovations emanating from the entire local ecosystem over the past few months has been very heartening. I am particularly pleased to see public sector technologies being licensed to local companies to address Singapore’s COVID-19 public health needs. At the same time, our local companies can commercialise and export these technologies.”

 

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