Thermo Fisher specimen collection device granted FDA EUA

Oct. 20, 2021

Thermo Fisher Scientific received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) to run COVID-19 tests from saliva samples collected with a self-contained device, according to a company news release.

Called the Spectrum Solutions SpectrumDNA SDNA-1000 collection device, the product is a self-contained system that provides 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 company said.

The product is designed for use with the company’s Amplitude Solution, which is a high-throughput molecular diagnostic system that allows labs to scale up to 8,000 samples per day. The accompanying test kit's multi-gene target design and updated interpretive software is designed to help labs detect SARS-CoV-2 variants.

Visit Thermo Fisher Scientific for more news