Receive our newsletter – data, insights and analysis delivered to you
  1. Uncategorised
July 3, 2020

Coronavirus company news summary – Centogene’s Covid-19 test receives EUA from FDA – UK-RTC Covid-19 tests to be mass produced

By Chloe Kent

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.

Related Companies

Content from our partners
Why this global life sciences COO believes relocation to Charleston, SC, was key to achieving next-level success
“This technique means everything to us”: How CGM devices empower users 
Ensuring quality and supply chain visibility for medical device components

Topics in this article:
NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. The top stories of the day delivered to you every weekday. A weekly roundup of the latest news and analysis, sent every Friday. The medical device industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU