FDA Grants Emergency Use Authorization for Two Next-Generation COVID-19 Assays from Thermo Fisher Scientific
Thermo Fisher Scientific, the world leader in serving science, today 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, both highly accurate 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.
"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," said Manoj Gandhi, senior medical director for genetic testing solutions, Thermo Fisher Scientific. "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 about two hours to enable broad, high-frequency testing.
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 health care 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. For more information on the TaqPath platform, please visit: www.thermofisher.com/covid19evolved
For In Vitro Diagnostic Use. For Emergency Use Authorization Only | Rx Only
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $30 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 80,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.