June 2021—Thermo Fisher Scientific announced the FDA has expanded emergency use authorization for the Applied Biosystems TaqPath COVID-19 Combo Kit to include the high-throughput Thermo Fisher Scientific Amplitude solution.
The Amplitude solution is a molecular diagnostic testing system that aims to help clinical labs expand their testing capacity by combining the company’s extraction and real-time PCR instruments with liquid-handling products from the Tecan Group. The modular system uses a high-throughput version of Thermo Fisher’s Applied Biosystems TaqPath COVID-19 Combo Kit, which received emergency use authorization in March 2020, to process samples in four steps. The platform can process up to 8,000 samples per day.
Testing with the Amplitude solution and the TaqPath COVID-19 combo kit is limited to CLIA-certified laboratories to perform high-complexity tests, or by similarly qualified non-U.S. laboratories.
Thermo Fisher Scientific, 781-622-1000