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April 13, 2021

FDA grants EUA to Thermo Fisher’s automated system for Covid-19 test

The US Food and Drug Administration (FDA) has granted emergency use authorization (EUA) to Thermo Fisher Scientific’s new automated system for Covid-19 testing.

The US Food and Drug Administration (FDA) has granted emergency use authorization (EUA) to Thermo Fisher Scientific’s new automated system for Covid-19 testing.

The Amplitude Solution with the TaqPath COVID-19 High-Throughput Combo Kit allows clinical and public health labs to scale gold standard PCR testing and process up to 8,000 samples daily, even with small staff numbers, as long as there is an assured supply of kits, reagents and consumables to meet testing requirements.

Currently, the Amplitude Solution is used worldwide, including in European and Japanese labs.

Thermo Fisher Scientific executive vice-president and chief operating officer Mark Stevenson said: “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.

“For population-wide testing programmes, 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.

“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.”

Aiding clinical labs to increase testing capacity, the molecular diagnostic testing system merges Thermo Fisher’s extraction and real-time PCR instruments with Tecan Group’s liquid handling products.

Using a high-throughput version of Thermo Fisher’s Applied Biosystems TaqPath COVID-19 Combo Kit, the modular system processes samples in four steps with minimum hands-on time and lab space needed.

The kit has a multi-gene target design and updated interpretive software to aid laboratories in identifying SARS-CoV-2 variants.

Thermo Fisher noted that clinical laboratory improvement amendments (CLIA) certified laboratories, or similarly qualified non-US labs, will now be able to carry out testing with the Amplitude Solution with TaqPath COVID-19 High-Throughput Combo Kit.

Last month, Thermo Fisher Scientific launched the Applied Biosystems QuantStudio 5 Dx Real-Time PCR System for clinical laboratories and assay developers.

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