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Genetron Covid-19 Test Receives FDA Emergency-Use Authorization

June 6, 2020, 1:15 PM

China-based Genetron Holdings Ltd. announced that it received emergency-use authorization from the U.S. Food and Drug Administration for its Covid-19 detection kits as well as permits from local authorities to export the product.

The virus-detection tests independently developed by Genetron Health, was put in a list of approved Covid-19 reagent manufacturers by the China Chamber of Commerce for Import and Export of Medicines and Health Products, Genetron said Saturday in an emailed statement.

The tests had already received CE marking showing European conformity and other certifications regarding health, safety, and environmental standards for products sold within the European Economic Area.

The Genetron SARS-CoV-2 RNA Test is believed to effectively detect large-scale samples for the novel coronavirus. The features include:

  • Enhanced accuracy by detecting two different and highly specific gene sequences of SARS-CoV-2.
  • It is quick and easy to operate, can be processed under 2.5 hours and is contamination resistant.

To contact the reporter on this story:
Prejula Prem in London at pprem1@bloomberg.net

To contact the editors responsible for this story:
Alaric Nightingale at anightingal1@bloomberg.net

Dulue Mbachu, James Amott

© 2020 Bloomberg L.P. All rights reserved. Used with permission.

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