FDA clears new saliva sample collection method for automated high-throughput COVID-19 testing system


CARLSBAD, California, October 18, 2021 / PRNewswire / – Thermo Fisher Scientific, the global leader in serving science, today announced that it has received Emergency Use Clearance (EUA) from the United States Food and Drug Administration (FDA) for perform COVID-19 testing from saliva samples collected with the Spectrum SpectrumDNA SDNA-1000 Solution Collection Device on the Amplitude solution.

SDNA saliva collection devices are stand-alone systems that ensure sample consistency and long-term stability while protecting DNA and RNA transcripts after collection to ensure accurate test results with just two milliliters of saliva. The Amplitude solution gives laboratories the ability to scale COVID-19 PCR tests and process up to 8,000 samples in a single day.

“With the increase in COVID-19 cases due to more transmissible variants such as the Delta variant, routine testing for SARS-CoV-2 remains an effective strategy to curb the pandemic,” said Manoj Gandhi, Senior Medical Director of Genetic Testing Solutions, Thermo Fisher Scientific. “By giving laboratories and public health officials additional flexibility in collecting samples over a high-throughput system, we improve their ability to meet the increased demand that helps monitor the spread of COVID-19 and, eventually, to save lives. “

The Amplitude solution is a molecular diagnostic system that enables clinical laboratories to expand their testing capacity with minimal labor, equipment and personnel. Its high-speed capabilities can be adapted to meet the testing needs of businesses, schools, universities and communities to help them return to pre-pandemic life. The kit’s multigene target design and updated interpretation software are also designed to help laboratories detect SARS-CoV-2 variants.

For more information on the Amplitude platform, visit: https://www.thermofisher.com/amplitude

About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the global leader in serving science, with annual sales exceeding $ 30 billion. Our mission is to empower our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life science research, solving complex analytical challenges, improving patient diagnostics and therapies, or increasing the productivity of their laboratories, we’re here to support them. Our global team of more than 80,000 colleagues deliver an unmatched combination of innovative technologies, purchasing convenience and pharmacy services through our industry-leading brands including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon . For more information, please visit www.thermofisher.com.

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SOURCE Thermo Fisher Scientific

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