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FDA Authorizes Thermo Fisher’s COVID-19 New Test Collection Method
Thermo Fisher can now run COVID-19 tests from saliva samples collected with the Spectrum Solutions SpectrumDNA SDNA-1000 collection device on the Amplitude Solution.
FDA recently granted emergency use authorization to Thermo Fisher Scientific to run new saliva sample collection methods on its COVID-19 tests.
The company’s molecular diagnostics Spectrum Solutions SpectrumDNA SDNA-1000 collection device on the Amplitude Solutions empowers clinical labs to expand testing capacity with minimal hands-on time, equipment, and staffing.
The system collects saliva samples from individuals infected with the coronavirus. The collection devices provide long-term stability while protecting DNA and RNA transcriptions post-collection to ensure accurate test results.
The test can flex its high-throughput capabilities to address testing needs for various organizations, including companies, schools, universities, and communities, to help them return to normal life.
Notably, the kit’s multi-gene target design and updated software are also designed to help labs detect SARS-CoV-2 variants, such as the most recently prominent Delta variant.
“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 at Thermo Fisher Scientific, said in the announcement.
“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,” Gandhi continued.
Early in the pandemic, Thermo Fisher Scientific launched its COVID-19 test kit. Then in October, the company received emergency use authorization for the testing kit to include an additional sample collection method provided by Everlywell.
In August 2021, FDA granted authorization for two of the company’s PCR-based COVID-19 test kits.
The test kits — TaqPath COVID-19 Fast PCR Combo Kit 2.0 and TaqPath COVID-19 RNase P Combo Kit 2.0 — are designed with increased target redundancy to compensate for current mutations and emerging SARS-CoV-2 variants.
The assays target eight different genes across three regions of the virus that causes COVID-19, ensuring the accuracy of results where gene expression may vary as new mutations emerge.
