MiRXES receives Provisional Authorisation from the Health Sciences Authority (HSA) in Singapore for the production and distribution of the Fortitude Kit to detect COVID-19.
Supply of real-time RT-PCR test, Fortitude kit, for the diagnosis of COVID-19 will be provided by Singapore-based biotech company, MiRXES. Earlier this year, the company has been licenced with the technology from Singapore’s Agency for Science, Technology and Research (A*STAR). The Provisional Authorisation by the HSA given to MiRXES legalizes it as the product owner to manufacture and distribute the diagnostic kit.
MiRXES has been manufacturing the diagnostic test kit since February 2020, under contract from A*STAR. The Fortitude kit has since been deployed to 13 Singapore hospitals, and laboratories, both public and private together with agencies and healthcare institutions across more than 20 other countries. These include Hong Kong, New Zealand, and the United States. Batches of the diagnostics kit were also donated with other medical supplies by the Singapore government to countries including Brunei, Indonesia, Myanmar and the Philippines.
Fortitude Kit is the first SARS-CoV-2 diagnostic test deployed as a complete kit in Singapore. The test kit detects the SARS-CoV-2 virus, which causes the novel coronavirus disease COVID-19. This is done with high accuracy using a 1-step real-time RT-PCR process.
The test was developed by researchers at A*STAR and the Department of Laboratory Medicine at Tan Tock Seng Hospital (TTSH). The development and pilot production of the test kit was supported by the Diagnostics Development (DxD) Hub, a national initiative led by A*STAR’s commercialisation arm, A*ccelerate.
MiRXES will continue to work closely with A*STAR and TTSH in monitoring the COVID-19 situation, and is committed to upgrading the diagnostic test kit on a regular basis.
“MiRXES is looking forward to supporting the local ramp-up in testing, as recently announced by Singapore’s Prime Minister. We are doing all we can to support governments and healthcare professionals in fighting COVID-19. Our long-standing partnership with A*ccelerate, and DxD Hub, together with our experience and capabilities in developing and producing PCR-based diagnostic tests enabled us to move swiftly in setting up the production of the Fortitude Kit and to scale at speed, while upholding stringent quality control frameworks,” said Dr. Zhou Lihan, Co-founder and CEO of MiRXES. [APBN]