Contract Pharma Staff05.13.20
Thermo Fisher Scientific Inc. received expanded emergency use authorization (EUA) from the FDA for its multiplex real-time PCR test for the qualitative detection of nucleic acid from SARS‑CoV‑2, the virus that causes COVID-19.
Thermo Fisher's Applied Biosystems TaqPath COVID-19 Combo Kit, initially granted EUA on March 13 and subsequently expanded on April 20, is designed to deliver test results within four hours of a sample being received and processed by a CLIA high-complexity lab. This third expansion further increases the number of high-throughput PCR instruments that labs can use to run tests and also provides new options for reagents and consumables used in sample preparation and extraction to provide greater flexibility in testing workflows.
In addition to the previously approved Applied Biosystems 7500 Real-time PCR series and a version of the Applied Biosystems QuantStudio 5, labs can now run tests on specific configurations of QuantStudio 7 Flex and QuantStudio 5 Real‑time PCR instruments, contributing significantly to the number of instruments available for testing.
This expanded EUA also increases the availability of RNA extraction reagents by adding the company's MagMAX viral/pathogen II nucleic isolation kit as an alternative. Additionally, the sample purification step has been updated to allow a variety of microplate options.
Thermo Fisher's Applied Biosystems TaqPath COVID-19 Combo Kit, initially granted EUA on March 13 and subsequently expanded on April 20, is designed to deliver test results within four hours of a sample being received and processed by a CLIA high-complexity lab. This third expansion further increases the number of high-throughput PCR instruments that labs can use to run tests and also provides new options for reagents and consumables used in sample preparation and extraction to provide greater flexibility in testing workflows.
In addition to the previously approved Applied Biosystems 7500 Real-time PCR series and a version of the Applied Biosystems QuantStudio 5, labs can now run tests on specific configurations of QuantStudio 7 Flex and QuantStudio 5 Real‑time PCR instruments, contributing significantly to the number of instruments available for testing.
This expanded EUA also increases the availability of RNA extraction reagents by adding the company's MagMAX viral/pathogen II nucleic isolation kit as an alternative. Additionally, the sample purification step has been updated to allow a variety of microplate options.
