Temasek’s wholly-owned subsidiary Advanced MedTech has announced that Australia’s Therapeutic Goods Administration (TGA) granted approval for Singapore-made RESOLUTE 2.0 direct multiplex Reverse-Transcription Polymerase-Chain-Reaction (RT-PCR) test kit for Covid-19.
Co-developed by Singapore’s Agency for Science Technology and Research and DSO National Laboratories (DSO), the kit has been made available for clinical use by Advanced MedTech.
Approval from TGA will enable the test kit to be used in laboratories and medical institutions across the country.
The RESOLUTE 2.0 test kit functions without the need for viral RNA extraction from patient test samples, making it one of the few such RT-PCR tests to get approval from TGA.
Advanced MedTech noted that the kit has high sensitivity and specificity towards SARS-CoV-2 despite a shortened laboratory processing time.
This can reduce potential human errors while reducing exposure of the virus to lab technicians and can deliver test results in half the time than other RT-PCR test kits.
Furthermore, the test kit can be paired with the complementary RAVE automated robotics lab system to process four times more daily throughput compared with the usual RT-PCR test.
RESOLUTE 2.0 will be used at a new Covid-19 testing lab that will open in Changi Airport, Singapore, this year.
Besides nasopharyngeal (NP) Covid-19 testing, RESOLUTE 2.0 test kit has recently received approval from Singapore’s Health Sciences Authority for deep-throat saliva (DTS) and oropharyngeal / middle turbinate (OPMT) testing.
Advanced MedTech Group CEO Abel Ang said: “We are pleased to work with the Australian authorities and Singapore’s Health Sciences Authority on attaining TGA’s approval, to help safely reopen their dynamic economy and bring jobs and trade back into the country.”