- TBG Diagnostics’ (TDL) subsidiary, TBG Biotechnology, has received the U.S. Food and Drug Administration’s (FDA’s) Emergency Use Authorisation (EUA) for its COVID-19 test kits
- The company’s ExProbe testing kit can detect distinctive gene segments of the SARS-CoV-2 virus, which causes COVID-19
- The FDA’s EUA justifies the use of the tests under extraordinary circumstances, such as the ongoing pandemic
- However, the tests are only authorised for laboratories, for the duration of the COVID-19 declaration relating to in vitro diagnostics
- TBG Diagnostics shares remain suspended from official quotation, last trading for 27 cents each
TBG Diagnostics’ (TDL) subsidiary, TBG Biotechnology, has received the U.S. Food and Drug Administration’s (FDA’s) Emergency Use Authorisation (EUA) for its COVID-19 test kits.
The company’s ExProbe SARS-CoV-2 Testing Kit is a diagnostic kit based on ribonucleic acid (RNA). The tests use real-time PCR technology to detect distinctive gene segments of the SARS-Cov-2 virus, which causes COVID-19.
Currently, the tests are commonly used for confirming active COVID-19 infections, from specific upper and lower respiratory samples.
The United States’ FDA has deemed the testing kits suitable, under its emergency access mechanism. The EUA justifies the use of the tests under extraordinary circumstances, such as the ongoing pandemic.
In this case, the EUA allows for the emergency use of in-vitro diagnostics (IVD’s) to detect or diagnose COVID-19 without review. The ExProbe kit has not undergone the standard review process that an FDA-approved IVD must usually pass.
TBG’s ExProbe test is one of only 100 IVD kits which has received COVID-19-related Emergency Use Authorisation from the FDA. However, the EUA only authorises the ExProbe kit for use in laboratories, where it will be used for high-complexity tests.
Also, the authorisation only lasts for the duration of the COVID-19 declaration relating to in-vitro diagnostic tests. This is unless the declaration about IVD’s is revoked or terminated, at which point the tests can not be used.
Having received the U.S. FDA’s EUA, the company will export the tests from Taiwan, where they are manufactured.
TBG Diagnostics shares remain suspended from official quotation, last trading for 27 cents each in March.