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August 17, 2021

US FDA approves two Thermo Fisher Covid-19 test kits

The Covid-19 kits are designed with increased target redundancy to address emerging SARS-CoV-2 variants.

US-based laboratory equipment supplier Thermo Fisher Scientific has received emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for two of its next-generation Covid-19 assays.

The two assays are the TaqPath Covid-19 Fast PCR Combo Kit 2.0 and TaqPath COVID-19 RNase P Combo Kit 2.0.

Both kits are designed with increased target redundancy to address current and emerging SARS-CoV-2 variants.

The PCR-based kits target eight different genes across three regions of the SARS-CoV-2 virus.

Thermo Fisher Scientific genetic testing solutions senior medical director 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 TaqPath Covid-19 Fast PCR Combo Kit 2.0 tests raw saliva samples and provides results in around two hours. It is designed to enable broad, high-frequency testing.

The test targets three different viral genomic regions and aims to reduce the risk of failing to detect SARS-CoV-2.

The TaqPath COVID-19 RNase P Combo Kit 2.0 has an approximate turnaround time of three hours.

It is designed to detect SARS-CoV-2 from individuals whose healthcare providers suspect they have Covid-19, as well as asymptomatic patients.

The company’s first-generation TaqPath Covid-19 Combo Kit secured EUA from the FDA last March.

In April, Thermo Fisher Scientific reported a 59% increase in revenue to $9.91bn in the first quarter of this year compared to last year.

The company’s diluted earnings per share (EPS) for the quarter, calculated using generally accepted accounting principles (GAAP), stood at $5.88. This was a 198% increase from $1.97 a year earlier.

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