Thermo Fisher’s Coronavirus Detection Kit Gets FDA Emergency Authorization
By Ruchi Jhonsa, Ph.D.
Edited by Rajaneesh K. Gopinath, Ph.D.
When Thermo Fisher Scientific announced its agreement to buy Qiagen earlier this month, analysts suggested that Thermo intends to expand its molecular diagnostic portfolio with Qiagen’s diagnostic test, QIAstat-Dx for detecting SARS-CoV-2. However, Thermo Fisher’s CEO, Marc N. Casper mentioned that the coronavirus business was not an important consideration. Although the volatility of the situation in China may have played a part in closing the deal, the plan for acquisition had started well before the outbreak in Wuhan. From the conference call that followed the announcement, one could understand that with their existing two PCR technologies, protective equipment, and research collaborations, Thermo Fisher was already playing its part in tackling the pandemic. Today it became clearer when it announced FDA’s emergency authorization (EAU) of its TaqPath COVID-19 combo kit that can be used immediately by laboratories approved to conduct high complexity tests in the U.S. to detect nucleic acid from SARS-CoV-2 virus. This news follows Roche’s announcement of emergency authorization approval for cobas SARS-CoV-2 kit to detect coronavirus in patient samples.
FDA commissioner Stephen M. Hahn, M.D. said, “Since the beginning of this outbreak, more than 80 test developers have sought our assistance with development and validation of tests they plan to bring through the Emergency Use Authorization process. Additionally, more than 30 laboratories have notified us they are testing or intend to begin testing soon under our new policy for laboratory-developed tests for this emergency. The number of products in the pipeline reflects the significant role diagnostics play in this outbreak and the large number of organizations we are working with to bring tests to market.”
Thermo Fisher has developed singleplex and multiplex assay kits for SARS-CoV2 pathogen detection that can be run on the company’s Applied Biosystems 7500 Fast Dx Real-time PCR instrument already covered under EUA and installed in several clinical laboratories worldwide. The kit will detect viral RNA by amplifying the nucleotide sequence multiple times.
Before the EUA announcement later yesterday, Thermo Fisher’s efforts were applauded by the president of the United States, Donald Trump in his address to the people yesterday afternoon. He thanked Thermo Fisher and indicated that FDA will hopefully authorize their test within 24 hours, which will bring an additional 1.4 million tests on board in a week. The Trump government has been criticized immensely for their lackluster attitude towards the problem. Approval of Thermo Fisher’s kit within 24 hours of the application shows the gravity of the situation and the government’s effort to solve the problem quickly.
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