Thermo Fisher Wins EUA for Next-Gen COVID-19 Test as Delta Rages On

Thermo Fisher Scientific has won emergency use authorization for a next-generation COVID-19 test as the Delta Variant wreaks havoc.

The Waltham, MA-based company said FDA granted the EUA for the TaqPath COVID-19 Fast PCR Combo Kit 2.0 and the TaqPath COVID-19 RNase P Combo Kit 2.0 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 the accuracy of results in situations where gene expression in the virus varies 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."

Thermo Fisher Scientific received EUA for the first generation of the TaqPath COVID-19 Combo kit in March of 2020. FDA said the test was granted several modifications through supplemental EUA requests between March and July 2020. TaqPath was granted CE mark in late March.

Right now, there has been a surge in COVID-19 cases in the U.S. – led by the Delta variant. The U.S. is averaging 124,000 new cases a day, up about 86% over the past 14 days. Deaths are up 75% over the same period, according to a report from Barrons.  

There are more than 200,000,000 cases of COVID-19 worldwide, according to statistics from Johns Hopkins. The data show there are more than 36,680,000 confirmed cases in the U.S. with 621,636.