Thermo Fisher granted EUA by FDA for two further assays

Thermo Fisher Scientific has been granted emergency use authorisation (EUA) by the U.S. Food and Drug Administration (FDA) for the TaqPath COVID-19 Fast PCR Combo Kit 2.0 and the TaqPath COVID-19 RNase P Combo Kit 2.0.

The two assays designed with increased target redundancy to compensate for current mutations and emerging SARS-CoV-2 variants.

Both PCR-based kits leverage an updated design from the original TaqPath assays, targeting eight different genes across three regions of the virus that causes COVID-19. This built-in redundancy helps ensure accuracy of results in situations where gene expression in the virus vary as new mutations emerge.

Manoj Gandhi, senior medical director for genetic testing solutions, Thermo Fisher Scientific, said: "The Delta variant is just the latest example of how SARS-CoV-2 mutations can have a major impact on the efficacy of global pandemic management. We are working to keep laboratories, public health officials and communities one step ahead of the virus, and these tests play a key role, alongside our full menu of diagnostic solutions, in supporting that effort."

The TaqPath COVID-19 Fast PCR Combo Kit 2.0 assesses raw saliva and uses a workflow from sample collection direct to PCR to help preserve supplies. Results are returned in approximately two hours.

The TaqPath COVID-19 RNase P Combo Kit 2.0 is designed with an approximate three-hour turnaround time and can detect SARS-CoV-2 from individuals suspected of COVID-19 by their healthcare provider, as well as from patients who are asymptomatic.

The first generation TaqPath COVID-19 Combo Kit received EUA from the FDA in March 2020.