Singaporean biotech has received Provisional Authorisation from the Health Sciences Authority for the widely-adopted Fortitude Kit, a diagnostic test that detects the virus that causes COVID-19
SINGAPORE, April 23, 2020 /PRNewswire/ — MiRXES, a homegrown Singapore-based biotech, has received Provisional Authorisation from the Health Sciences Authority (HSA) Singapore, to supply the Fortitude Kit SARS-CoV-2 real-time RT-PCR[1] test. With technology licensed from Singapore’s Agency for Science, Technology, and Research (A*STAR) and the HSA Provisional Authorisation, MiRXES becomes a legal product owner to manufacture and distribute the Fortitude Kit. MiRXES produces the Fortitude Kit RT-PCR test for COVID-19 The diagnostic test kit has been manufactured by MiRXES under contract from A*STAR since February 2020.  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. To date, the Fortitude Kit has been deployed in 13 Singapore hospitals and labs, public and private, and more than 20 countries internationally. It has been procured by agencies and healthcare institutions around the world, including those in Hong Kong, New Zealand, and the United States. Batches of Fortitude Kit were also part of the medical supplies donated by the Singapore Government to countries including Brunei, Indonesia, Myanmar and the Philippines. Given the growing number of mutations in reported SARS-CoV-2 genomes, MiRXES continues to work closely with A*STAR and TTSH to monitor the evolution of the novel coronavirus, and is committed to upgrading the diagnostic test on a regular basis to stay ahead of mutations. "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. Email fortitude@mirxes.com for more information. [1] RT-PCR (reverse transcriptase polymerase chain reaction) tests are the gold standard for diagnosing active viral infections through the detection of viral RNA from patient samples. About MiRXES MiRXES is a Singapore-headquartered biotech company founded in 2014 as a spin-off from A*STAR, with operations in Singapore, US, Japan, and China. MiRXES has built end-to-end life science research and in vitro diagnostic (IVD) product development capabilities and operates two ISO13485-certified manufacturing facilities. In addition to the COVID-19 tests, we harness our industry-leading quantitative RT-PCR-based microRNA detection technology platform to deliver clinical applications that can detect diseases early and save lives. MiRXES has launched GASTROClear, the world’s first microRNA-based blood test for stomach cancer, approved by Singapore’s HSA, and has curated the world’s largest database of clinical microRNA profiles from studies of over 30 diseases, including more than 10 cancer types, heart failure, and diabetes. For more information, visit www.mirxes.com. Photo – https://photos.prnasia.com/prnh/20200423/2784764-1?lang=0Related Links :http://www.mirxes.com
Source: prnasia

  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •