Centogene has received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for its SARS-CoV-2 RT-PCR test. The SARS-CoV-2 RT-PCR test is based on the reverse transcription polymerase chain reaction (RT-PCR) to detect Covid-19 causing SARS-CoV-2 virus. Samples from upper respiratory tract that are collected from patients will be used for the test.
Fluxergy has announced that it will collaborate with Mass General Brigham (MGB) to explore Fluxergy's Research Use Only (RUO) Covid-19 testing platform. This platform is expected to provide PCR test results within one hour. The company has sent a request to the US Food and Drug Administration (FDA) for an Emergency Use Authorization (EUA) which will permit certified laboratories to use the tool.
The FDA has issued an EUA for the third diagnostic test to detect and differentiate the viruses that lead to flu and Covid-19 in patients who may have Covid-19. Previously, the FDA has issued EUAs to BioFire Diagnostics and QIAGEN for their Covid-19 tests.
The UK-Rapid Test Consortium (UK-RTC) has announced that it has reached ‘design freeze’ for its Covid-19 antibody test. The consortium was set up in April this year in order to develop and manufacture Covid-19 antibody tests which will identify if the immune system of a person has responded to the Covid-19 infection. With this milestone, the test kits can now be mass produced for distribution.