Thermo Fisher Scientific has secured an emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its TaqPath Covid-19 Fast PCR Combo Kit 2.0 and the TaqPath COVID-19 RNase P Combo Kit 2.0 assays.
The new accurate assays have been developed with increased target redundancy to recoup for current mutations, as well as for emerging SARS-CoV-2 variants.
Both PCR-based kits leverage an enhanced design from the original TaqPath assays to target eight different genes across three regions of the virus, which leads to Covid-19.
The TaqPath COVID-19 Fast PCR Combo Kit 2.0 has been designed to evaluate raw saliva and use a simple workflow from sample collection direct to PCR to help conserve supplies. It helps to deliver results in around two hours to support high-frequency testing.
With an around three-hour turnaround time, the TaqPath COVID-19 RNase P Combo Kit 2.0 will help identify SARS-CoV-2 from individuals suspected of Covid-19 by their health care provider and from patients who are asymptomatic.
Thermo Fisher Scientific genetic testing solutions senior medical director Dr Manoj Gandhi 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 company secured EUA status from the FDA for the first generation TaqPath Covid-19 Combo Kit in March 2020.
In March this year, Thermo Fisher launched Applied Biosystems TaqMan SARS-CoV-2 Mutation Panel, which is a customisable menu of 22 verified real-time PCR assays for the detection of SARS-CoV-2 mutations.
