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Thermo Fisher Scientific has announced that it expects to produce up to five million testing kits during April, to detect nucleic acid from the SARS-CoV-2 virus that causes coronavirus (Covid-19).
At present, the company has 1.5 million tests available to ship under the emergency use authorisation (EUA) label.
The US Food and Drug Administration (FDA) issued a EUA for Thermo Fisher’s diagnostic test that can be used immediately by CLIA high-complexity laboratories in the US to detect the nucleic acid.
The company expects to ramp up to reach two million tests a week, and scale production up to five million per week, based on the availability of raw materials and an installed instrument base.
Thermo Fisher plans to initially distribute the available tests to about 200 labs in the US.
Additionally, the company said it will continue to work with government agencies and private partners to expand their access.
Thermo Fisher Scientific chairman, president and CEO Marc Casper said: “The authorisation of our diagnostic test for Covid-19 will help to protect patients and enable medical staff to respond swiftly to treat those who are ill and prevent the spread of infection.
“In partnership with the FDA and regulatory authorities around the world, we are committed to expanding the availability of diagnostic testing to prevent the spread of this disease.”
The test, which makes use of Applied Biosystems TaqPath Assay technology, provides patient results within four hours of a sample being received by a lab.
