FDA Grants EUA for Two Next-Gen COVID-19 Assays from Thermo Fisher
The global leader in serving science, Thermo Fisher Scientific has announced that the U.S. Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for the TaqPath COVID-19 Fast PCR Combo Kit 2.0 and the TaqPath COVID-19 RNase P Combo Kit 2.0.
The second-gen PCR-based kits provide more accurate results for current mutations and emerging SARS-CoV-2 variants
The highly accurate assays are developed with increased target redundancy to compensate for current mutations and emerging SARS-CoV-2 variants. Both PCR-based kits leverage an overhauled design from the original TaqPath assays, targeting eight different genes across three regions of the virus that causes the COVID-19 disease. This integrated redundancy helps ensure the accuracy of results in situations where gene expression in the virus varies as new mutations and variants materialise.
Manoj Gandhi, senior medical director for genetic testing solutions, Thermo Fisher Scientific stated:
“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 simple workflow from sample collection direct to PCR to help preserve supplies. Results are returned in approximately 2 hours to facilitate broad, high-frequency testing.
The TaqPath COVID-19 RNase P Combo Kit 2.0 is designed with an approximate turnaround time of 3 hours and can detect SARS-CoV-2 from individuals suspected of COVID-19 by their health care provider, as well as from patients who are asymptomatic.*
The first generation Thermo Fisher TaqPath COVID-19 Combo Kit received EUA from the FDA in March 2020.
For more information on the TaqPath platform, please visit: www.thermofisher.com/covid19evolved