Thermo Fisher intends to roll out the test for qualified laboratories across the European Union, and will provide update on other approvals received till date
Thermo Fisher Scientific's previous headquarters in Waltham, Massachusetts. (Credit: Coolcaesar/Wikipedia.)
US-based Thermo Fisher Scientific has obtained the CE mark approval for its diagnostic test to detect nucleic acid from SARS-CoV-2, the virus that causes COVID-19, in the European Union.
The company has developed the new advanced test, which uses Applied Biosystems TaqPath Assay and real-time PCR technology, to provide results within four hours after a sample being received. The estimated time taken for results also includes sample preparation and instrument analysis time.
Thermo Fisher Scientific chairman, president and chief executive officer Marc Casper said: “The CE mark certification is an important step in combatting the outbreak of COVID-19 across Europe.
“We are committed to fighting this disease and we will continue to work with regulatory authorities and customers around the world to expand the availability of diagnostic testing and stem the spread of the coronavirus.”
The FDA granted EUA for Applied Biosystems 7500 Fast Real-Time PCR System
Thermo Fisher said that the CE mark confirms that its test is in line with the EU’s In-vitro Diagnostic Directive, encompassing products manufactured in the European Economic Area.
In addition, the company has secured the Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for its COVID-19 test on 13 March 2020.
The FDA EUA approval has been expanded include additional instruments, including the company’s Applied Biosystems 7500 Fast Real-Time PCR System.
The expansion is also said to include manual sample extraction using the MagMax Viral/Pathogen Nucleic Acid Isolation Kit, along with Applied Biosystems COVID-19 Interpretive Software.
In addition to receiving the approvals in the US and EU, the new diagnostic test has also been granted approvals in Canada, Singapore, India, Australia and New Zealand.
Thermo Fisher claimed that it has created an online resource to help people find the latest information about the COVID-19 pandemic, including the availability of its diagnostic test kits.