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Thermo Fisher Scientific Gets CE Mark for High-Throughput COVID-19 Assay

NEW YORK – Thermo Fisher Scientific said on Monday that it has received the CE mark for and has launched the Applied Biosystems TaqPath COVID-19 HT Kit, a high-throughput version of its TaqPath COVID-19 RT-PCR kit that received the CE mark last March. That same month, another version, TaqPath COVID-19 Combo Kit, received Emergency Use Authorization from the US Food and Drug Administration.

The new kit runs on the company's Amplitude platform, an automated molecular diagnostics system that combines Thermo Fisher's nucleic acid extraction and real-time PCR instruments with liquid handling stations from Tecan and enables laboratories to test up to 8,000 samples per day for COVID-19.

The assay kit also received interim authorization from Health Canada on Jan. 21, and Thermo Fisher has signed a deal for Amplitude systems with a large Canadian provincial authority.

"The Amplitude platform embodies our goal of empowering public health and clinical lab professionals to generate accurate results at higher volumes and use them to make informed healthcare decisions that lead to the management of a pandemic that is still raging around the world," said Mark Smedley, president of Thermo Fisher's genetic sciences business, in a statement.

Thermo Fisher noted that Amplitude customers are guaranteed reagents through a supply agreement and that it has the capacity to produce more than 20 million COVID-19 tests per week.