FDA grants EUA to Thermo Fisher test

April 13, 2021

Thermo Fisher Scientific announced that the U.S. Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for the Thermo Fisher Scientific Amplitude Solution with the TaqPath COVID-19 High-Throughput Combo Kit, according to a news release.

Thermo Fisher said the Amplitude Solution enables clinical and public health laboratories to scale the PCR testing and process up to 8,000 samples in a single day with minimal staffing resources and a secured supply of kits, reagents, and consumables to meet their testing needs.

"While COVID-19 cases globally may be decreasing in some areas as vaccines become more widely available, there continues to be a demand for frequent routine testing to control future outbreaks," said Mark Stevenson, Executive Vice President and Chief Operating Officer of Thermo Fisher Scientific.

The Amplitude Solution combines Thermo Fisher's extraction and real-time PCR instruments with liquid handling products from Tecan Group. The modular system utilizes a high-throughput version of Thermo Fisher's Applied Biosystems TaqPath COVID-19 Combo Kit, which received EUA in March 2020, to process samples in four steps with minimal hands-on time and laboratory space requirements. The kit's multi-gene target design and updated interpretive software may help labs detect SARS-CoV-2 variants.

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