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FDA Authorizes New Saliva Sample Collection Method

Thermo Fisher Scientific, the world leader in serving science, today announced that it received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) to run COVID-19 tests from saliva samples collected with the Spectrum Solutions SpectrumDNA SDNA-1000 collection device on the Amplitude Solution.

SDNA saliva collection devices are self-contained systems that provide sample consistency and long-term stability while protecting DNA and RNA transcripts post-collection to help ensure accurate test results with only two milliliters of saliva. The Amplitude Solution gives laboratories the ability to scale COVID-19 PCR testing and process up to 8,000 samples in a single day.

"With the increase of 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 enabling labs and public health officials with additional flexibility in sample collection on a high-throughput system, we are improving their ability to meet the increased demand which helps to monitor the spread of COVID-19 and, eventually, save lives."

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by Route of Administration (Oral, Injectors, Implantable, Syrups, Gels, Pulmonary, Solutions, Tablets, Syringes), Application (Cancer, Diabetes), Facility of Use (Hospitals), COVID-19 Impact

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The Amplitude Solution is a molecular diagnostic system that empowers clinical labs to expand testing capacity with minimal hands-on time, equipment and staffing. Its high-throughput capabilities can be flexed to address testing needs for companies, schools, universities and communities to help them return to pre-pandemic life. The kit's multi-gene target design and updated interpretive software is also designed to help labs detect SARS-CoV-2 variants.

Source: Thermofisher
Date: Oct 18, 2021


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