FDA grants Thermo Fisher EUA for next-gen COVID tests 

Aug. 16, 2021

The U.S. FDA has granted Thermo Fisher Scientific emergency use authorization for two PCR-based kits leveraging an updated design that compensates for current mutations and emerging COVID variants.

Thermo's first-generation TaqPath Combo Kit received EUA from the FDA in March 2020. The updated versions — the TaqPath COVID-19 Fast PCR Combo Kit 2.0 and the TaqPath COVID-19 RNase P Combo Kit 2.0 — target eight different genes across three regions of the virus. The company says that this built-in redundancy will help ensure the accuracy of results in situations where gene expression in the virus varies as new mutations emerge.

The 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 RNase P Combo Kit 2.0, which requires a nasal swab, is designed with an approximate three-hour turnaround time and can detect SARS-CoV-2 from individuals suspected of COVID-19 infection, as well as from asymptomatic patients.

Read the press release