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Thermo Fisher Scientific Gets FDA EUA for High-Throughput, Automated COVID-19 Test Kit

NEW YORK – Thermo Fisher Scientific said on Monday that it has received Emergency Use Authorization from the US Food and Drug Administration for its Amplitude Solution with the TaqPath COVID-19 High-Throughput Combo Kit.

This modular system uses a high-throughput version of the Applied Biosystems TaqPath COVID-19 Combo Kit, which received an EUA in March 2020, enabling laboratories to rapidly scale their capacity for high-sensitivity PCR testing. The Amplitude Solution is a molecular diagnostic testing system that combines Thermo Fisher's extraction and real-time PCR instruments with liquid handling products from Tecan Group, the company said, adding that the kit's multi-gene target design and updated interpretive software may help labs detect SARS-CoV-2 variants. The firm also noted that the Amplitude Solution will allow labs to process up to 8,000 samples per day, with minimal staffing resources and a secured supply of kits, reagents, and consumables, and that the system has already been implemented in labs in Europe and Japan.

"For population-wide testing programs, lab-based PCR is the best fitting technology, providing confidence in results, capacity to process thousands of samples a day, and consistent, reliable turnaround times," Thermo Fisher Chief Operating Officer Mark Stevenson said in a statement. "The Amplitude Solution can help support a systematic testing strategy by enabling labs to quickly scale their testing and begin processing high-volume samples, even with limited personnel."

Thermo Fisher has received EUAs and CE marks for multiple COVID diagnostics. In addition to the EUA it received for the TaqPath COVID-19 Combo Kit in March 2020, the company received the CE mark for the high-throughput version of test kit this February, and also received an EUA for a multiplex real-time PCR test for COVID-19 and influenza in the same month. Including this latest test kit, the company has six diagnostics aimed at COVID-19 or a combination of infectious diseases approved for use in the US and Europe.