FDA Issues EUA for New Saliva Sample Collection for Thermo Fisher Device
The company announced the Emergency Use Authorization (EUA) for use with its Spectrum Solutions SpectrumDNA SDNA-1000 collection device on the Amplitude Solution.
The Food and Drug Administration (FDA) has issued Thermo Fisher Scientific an EUA to run COVID-19 tests from saliva samples collected with their Spectrum Solutions SpectrumDNA SDNA-1000 collection device on the Amplitude Solution.
According to the company, 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. This gives laboratories the ability to scale up COVID-19 PCR testing and process up to 8000 samples a 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," Manoj Gandhi, senior medical director of genetic testing solutions, Thermo Fisher Scientific, said. "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."
The Amplitude Solution is a molecular diagnostic system with high-throughput capabilities can be flexed to address testing needs for companies, schools, universities and communities. The kit's multi-gene target design and updated interpretive software is also designed to help labs detect SARS-CoV-2 variants.