Cellmid Ltd - Cellmid enter into supply agreement for COVID-19 rapid diagnostic test
Cellmid Ltd (ASX:CDY)

Cellmid enter into supply agreement for COVID-19 rapid diagnostic test


What's happened?

Cellmid Ltd (ASX: CDY, “Cellmid”) have announced that it has entered into a supply agreement for a COVID-19 rapid diagnostic test with an authorized distributor of the manufacturer, Guangzhou Wondfo Biotech Co Ltd., supplying Australia.

What are the key highlights?

  1. The COVID-19 rapid diagnostic test was approved as a POCT (point of care test) by the TGA on 25 March 2020, by the NMPA in China on 24 February 2020 and the test received CE mark on 5 March 2020.
  2. The rapid diagnostic test is already used in several countries including the UK, Belgium, Spain and Germany. It is produced in a TGA approved facility in China and it is available immediately.
  3. The COVID-19 rapid test is a small disposable kit that uses a lateral flow colloidal goldbased detection method against viral specific IgG/IgM, delivering results in no more than 15 minutes, and requiring only the most basic of laboratory equipment.
  4. Clinical validation studies have been completed by the manufacturer according to Administrative Measures for Registration of In-vitro Diagnostic Reagents by the NMPA making use of 596 clinical samples and have shown specificity of 99.57% and a sensitivity of 86.43% on day 3 and 95% on day 5 of infection. Cross comparison of gold standard PCR based testing with the device showed a 94.93% coincidence, proving that the device is positioned as an excellent rapid screening tool.

CEO's Summary

Maria Halasz

“Learning from countries that managed the coronavirus infections well it is clear that widespread COVID-19 testing, isolation of those testing positive and early treatment are the best methods to control the spread of infection, while saving lives and medical resources. We are excited to be able to contribute to Australia’s comprehensive effort to manage this pandemic.”

Maria Halasz
CEO, Cellmid Ltd

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