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Thermo Fisher Scientific Receives CE Mark for TaqPath COVID-19 RNase P 2.0 Testing Kit

NEW YORK – Thermo Fisher Scientific said on Thursday that it has received CE-IVD marking for its TaqPath COVID-19 RNase P 2.0 kit, which has been designed to provide accurate results by compensating for current and future COVID-19 viral mutations.

The test was also granted Emergency Use Authorization by the US Food and Drug Administration in July.

The kit has been designed to detect active SARS-CoV-2 infections by identifying the presence of any one of eight gene targets from the virus, Thermo Fisher said. By surveying across multiple genes, it can provide accurate results even as mutations occur. The kit also uses an RNase P control to ensure sample integrity, quality, and extraction and can assess nasopharyngeal and nasal swab samples to detect active COVID-19 cases. The test has a turnaround time of about three hours.

"SARS-CoV-2 is continuing to mutate, and this assay is the latest in our efforts to make sure our tests are future proofed against those variants," Manoj Gandhi, senior medical director for genetic testing solutions at Thermo Fisher, said in a statement. "With this product, we are offering customers the next generation of our COVID-19 diagnostic test that has inbuilt checks and balances in the face of emerging variants."