Thermo Fisher Scientific has secured CE mark approval for its diagnostic test for the detection of nucleic acid from SARS-CoV-2, the novel virus responsible for COVID-19 disease.
The approval allows Thermo Fisher to market its diagnostic test across the European Union.
Thermo Fisher’s COVID-19 diagnostic test uses Applied Biosystems TaqPath assay and real-time PCR technology
By using Applied Biosystems TaqPath assay and real-time PCR technology, the Thermo Fisher test delivers patient results within four hours after the sample reaches a lab.
The estimated time-to-result is also comprised of sample preparation and instrument analysis.
On 13 March, the company has also secured emergency use authorisation from the US Food and Drug Administration for its COVID-19 test.
On 24 March, the authorisation has been revised to include additional instruments such as the firm’s Applied Biosystems 7500 Fast Real-Time PCR System.
The expansion enabled to increase testing capabilities in the US from around 1,000 instruments to over 3,000 instruments on which the company’s diagnostic test can be conducted.
In addition, the expansion comprised of manual sample extraction using the MagMax Viral/Pathogen Nucleic Acid Isolation Kit and Applied Biosystems COVID-19 Interpretive Software.
Thermo Fisher’s diagnostic test has also secured the designated approvals in Canada, Singapore, India, Australia, and New Zealand, apart from the designated approvals in the US and EU.
Thermo Fisher Scientific president and CEO 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.”
Recently, Thermo Fisher Scientific has entered into an agreement with Janssen Biotech to co-develop a companion diagnostic (CDx) for cancer.
As per terms of the deal, Thermo Fisher will work with the scientists of Janssen Research & Development, to validate various biomarkers for use with Thermo Fisher’s Oncomine Dx Target Test.
