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FDA expands EUA for TaqPath COVID-19 combo kit

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“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,” Mark Stevenson, executive vice president and chief operating officer of Thermo Fisher Scientific, said in a press release. “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. 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.”

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.

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