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Thermo Fisher Scientific Inc. has been granted expanded emergency use authorization from the FDA for its real-time, multiplex PCR test for detecting the nucleic acid associated with SARS-CoV-2, the coronavirus that causes COVID-19.
Thermo Fisher Scientific is at the forefront in the response to the global COVID-19 pandemic. This is especially true when it comes to the analysis of the virus, testing diagnosis, and personal protection equipment. The company is working closely with government agencies and researchers around the world to ensure access to their innovative instruments, consumables, and safety supplies to address the pandemic.
Thermo Fisher’s unique Applied Biosystems TaqPath COVID-19 Combo Kit, was first granted an expanded emergency use authorization on March 13. The FDA subsequently extended that on April 20.
The test is designed to produce test results within four hours upon receipt of the sample and its processing by a CLIA high-complexity lab. This latest expansion greatly increases the number of high-throughput PCR instruments that testing labs can use. It also provides test labs with more options for consumables and reagents used in sample preparation and extraction. Ultimately, it provides enhanced flexibility in testing workflows.
In addition to the previously approved version of the Applied Biosystems QuantStudio 5 and the Applied Biosystems 7500 Real-time PCR series, labs all over the world can now run tests on specific configurations of QuantStudio 5 Real-time and QuantStudio 7 Flex PCR instruments. Ultimately, this will be a significant contribution to the overall number of instruments that can be used for COVID-19 testing.
This expanded emergency use authorization also maximizes the availability of RNA extraction reagents by including Thermo Fisher’s MagMAX viral/pathogen II nucleic isolation kit as an alternative. Moreover, the sample purification step is now updated, allowing for a variety of microplate options.
Thermo Fisher Scientific is a global leader and trusted healthcare partner providing end-to-end, comprehensive research solutions for detecting pathogens, including SARS-CoV-2. The company has scientific expertise, as well as the support capacities, that are needed to win the war against the current COVID-19 outbreak. Their equipment and testing supplies can help frontline healthcare workers quickly combat the outbreak with ready-to-use qPCR research workflow products, as well as the stand-alone research components, referenced in WHO and CDC protocols.
Thermo Fisher Scientific Inc is predicting the need for COVID-19 testing supplies could give a $750 million tailwind to the company during the second quarter. However, the company speculated when posting its first-quarter results that the benefit of increased testing sales could be offset by the disruptions COVID-19 caused to its overall sales; organic sales of other products fell by 15% during the first quarter.
Thermo Fisher warned investors of the impact COVID-19 would have when it withdrew its guidance for 2020. Thermo Fisher continued along pre-COVID-19 trajectories during the first quarter, with lab and life science products continuing to grow, with specialty diagnostics flat and analytical instruments contracting.
The effects of the COVID-19 pandemic are showing a greater impact to the company over time. For example, Thermo Fisher sales in China fell 25% during the quarter. The company’s North American and European units only were impacted by the pandemic in late March.
Thermo Fisher’s broad portfolio could mean COVID-19 is creating lucrative opportunities with the company. Thermo Fisher’s diagnostic unit benefited the most from the pandemic, driving sales up into the double digits. Depending on the number of COVID-19 tests performed during the second quarter, Thermo Fisher expects the pandemic could add $400 million to $750 million in revenues during the current financial period.