FDA Authorizes Thermo Fisher’s PCR-Based COVID-19 Test Kits

FDA recently granted emergency use authorization for Thermo Fisher Scientific’s two PCR-based COVID-19 test kits.

The test kits, TaqPath COVID-19 Fast PCR Combo Kit 2.0 and TaqPath COVID-19 RNase P Combo Kit 2.0, are designed with increased target redundancy to compensate for current mutations and emerging SARS-CoV-2 variants.

The assays target eight different genes across three regions of the virus that causes COVID-19, ensuring accuracy of results where gene expression may vary as new mutations emerge, a Thermo Fisher Scientific spokesperson explained.

"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," Manoj Gandhi, senior medical director for genetic testing solutions at Thermo Fisher Scientific, said in the announcement.

"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,” Gandhi continued.

The TaqPath COVID-19 Fast PCR combo Kit 2.0 assesses raw saliva and uses a simple workflow from sample to PCR to help preserve supplies. Results of the test are available to patients in two hours.

And the TaqPath COVID-19 RNase P Combo Kit 2.0 can detect SARS-CoV-2 from individuals suspected of COVID-19, as well as asymptomatic patients. The turnaround time for this test is about three hours.

In March 2020, FDA issued the fourth COVID-19 diagnostics emergency use authorization to Thermo Fisher for its TaqPath COVID-19 Combo Kit.

Then in October, the agency expanded the authorization for the TaqPath Combo Kit to be used in combination with Everlywell’s COVID-19 Test Home Collection Kit, allowing individuals to self-collect nasal swab specimens when authorized by a healthcare professional.

CLIA-certified laboratories running Thermo Fisher’s TaqMan SARS-CoV-2 RNase P Assay Kit processes these samples. Patients can view results through the Everlywell online platform.

And most recently, Thermo Fisher Scientific updated its Applied Biosystems TaqMan SARS-CoV-2 Mutation Panel to detect the Delta and Lambda COVID-19 strains.

Last March, the company launched the research panel, which contains a customizable menu of verified real-time PCR assays to identify SARS-CoV-2 mutations. 

The panel can run a few or hundreds of samples to identify one or many mutations, enabling laboratories to meet the need for multiple testing with real-time PCR instruments already in use.