Singapore, Dec. 10, 2020 (GLOBE NEWSWIRE) --
- APPROVAL ALLOWS RESOLUTE 2.0 TEST KIT TO BE USED WITH A VARIETY OF TESTING METHODS – INCLUDING DEEP-THROAT SALIVA, OROPHARYNGEAL/MIDDLE TURBINATE AND NASOPHARYNGEAL TEST SWABS
- RESOLUTE 2.0 WILL BE USED AT SINGAPORE CHANGI AIRPORT WITH THE NEW ON-SITE ADDITION OF A COVID-19 TESTING LAB IN 2021.
Advanced MedTech Holdings (AMTH), a global medical technology leader headquartered in Singapore, announced today that the RESOLUTE 2.0 test kit has become the first RT-PCR COVID-19 test to be authorised by Singapore’s Health Sciences Authority (HSA) for deep-throat saliva (DTS) SARS-CoV-2 testing.
The clinical performance of DTS is supported by clinical studies involving the Diagnostics Development (DxD) Hub hosted by the Agency for Science, Technology and Research (A*STAR); Temasek Foundation; Changi General Hospital (CGH); DSO National Laboratories (DSO); and Woodlands Health Campus (WHC). The tests conducted on DTS specimens were able to accurately identify all the known positive cases in the clinical studies.
Using DTS, specimen collection is much less invasive and more comfortable for patients than current collection through swabs inserted into the back of the nose or throat. DTS collection only requires patients to draw out saliva from deep within their throat and spit into a specimen bottle. This makes it easy-to-administer and allows patients to conduct the collection themselves without the supervision of medical professionals, therefore mitigating the risks of potential virus spread as well.
RESOLUTE 2.0, eliminates the need for extraction of viral RNA from patient test samples and minimises potential human errors while cutting down test delivery time by half when compared to other approved RT-PCR tests. The test kit will be administered at a new COVID-19 testing lab that will open in Changi Airport in 2021 and speed up current testing capabilities and increase output samples to more than four times the output capacity of a lab using conventional RT-PCR tests. It is an industry-first direct multiplex RT-PCR COVID-19 test kit co-developed by A*STAR and DSO National Laboratories, manufactured and distributed by AMTH.
Although there have been a number of reports and studies relating to the use of DTS specimen, most involved the off-label use of assays. This could be one reason for inconsistencies in the performance of DTS as a specimen. Saliva testing by RESOLUTE 2.0 was authorised based on a standardised DTS collection and assay workflow, which would ensure the consistency and accuracy of the performance.
Abel Ang, Group Chief Executive of Advanced MedTech, said: “ No patient wants to have a swab poked up their nose or the back of their throat. Having a fast, painless, and accurate COVID-19 test kit like RESOLUTE 2.0 authorised for deep throat saliva testing by Health Sciences Authority, a leading health regulator in the region, is a game changer for Singapore as we reopen our borders, revive our conventions, and rebuild the air hub status of Changi Airport.”
Mr Frederick Chew, Chief Executive Officer, A*STAR, said: “Testing for COVID-19 will still be the norm for some time to come, even as we open up our economy and borders, until vaccines or treatments become more commonplace. Public sector researchers continue to work hard with industry partners to provide COVID-19 testing innovations for Singaporeans. We trust that this newly-approved DTS method will make the testing process smoother.”
Mr Cheong Chee Hoo, Chief Executive Officer, DSO, said: “DSO and its partners continue to push the boundaries to develop faster and more effective solutions to combat COVID-19. This close collaboration has enabled the extension of DSO’s DTS processing for RESOLUTE 2.0, and will make a big difference in simplifying the sample collection process and reducing the exposure for our frontline personnel.”
Associate Professor Ng Wai Hoe, Chief Executive Officer, Changi General Hospital, said: “As an acute hospital providing care for the community, CGH is happy to support the development of the deep throat saliva test kit, anchored on a clinical study which yielded accurate test results with specimens from COVID-19 patients. The kit offers an additional option and flexibility for COVID-19 testing in the community to suit screening and diagnostic requirements. Besides superior comfort and ease of use, it serves to reduce the exposure risk for swabbers and other healthcare workers during sample collection."
About Advanced MedTech Holdings
Advanced MedTech Holdings is a global medical technology leader with a core focus in urology devices and services. Headquartered in Singapore, with operations in US, Germany, Spain, France, Italy, China, Malaysia and Japan, the Company serves millions of patients and physicians in 100 countries worldwide. Advanced MedTech Holdings makes strategic investments in disruptive medical technology companies, strengthening its portfolio of healthcare solutions for customers around the world. Advanced MedTech Holdings is a wholly-owned subsidiary of Temasek. For more information on Advanced MedTech Holdings, please visit https://www.advanced-medtech.com/.
About RESOLUTE 2.0
RESOLUTE 2.0, an industry-first SARS-CoV-2 direct multiplex Reverse-Transcription Polymerase-Chain-Reaction (RT-PCR) assay kit co-developed by Singapore’s Agency for Science Technology and Research (A*STAR) and DSO National Laboratories (DSO), has been made available for clinical use in Singapore by Advanced MedTech Holdings (AMTH), a global medical technology leader. 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. For more information on the RESOLUTE 2.0 test, please visit www.advancedcovidtest.com
Advanced MedTech Media Contacts:
| Weikang Lee Advanced MedTech Holdings +65 6572 6074 weikang.lee@advanced-medtech.com Emma Thompson /Thomas Harding / Khushboo Tanna / Maryanne Lee Spurwing Communications +65 6751 2021 advanced@spurwingcomms.com |