Promega has secured approval for the usage of its GoTaq Probe 1-Step RT-qPCR System in Centers for Disease Control and Prevention’s (CDC) COVID-19 Emergency Use Authorization (EUA) diagnostic panel.
The system is now a recommended master mix option for the CDC’s 2019-Novel Coronavirus Real-Time RT-PCR Diagnostic Panel, which is available through the EUA of the Food and Drug Administration (FDA).
Promega clinical diagnostics director Heather Tomlinson said: “Thanks to the CDC acting quickly to make product additions to their protocol, labs now have one more CDC-approved master mix when performing the 2019-Novel Coronavirus Real-Time RT-PCR Diagnostic Panel.
“The Promega GoTaq Probe 1-Step RT-qPCR System expands the testing capacity in the US by being another option for labs to use for the amplification process in the CDC’s testing protocol.”
Promega reagents are currently incorporated in 15 COVID-19 diagnostic tests
The GoTaq Probe 1-Step RT-qPCR System is a turn-key master mix of optimised components for robust RT-qPCR using hydrolysis probes.
The FDA has granted an approval to the CDC’s diagnostic COVID-19 assay that includes Promega’s master mix as an approved amplification reagent for laboratories using the CDC’s assay.
CDC’s assay protocol is being used by many public health labs and clinical testing labs in the US and is referenced by thousands of labs around the world.
Established in 1978, Promega is engaged in providing advanced solutions in the areas of genomics, proteomics, cellular analysis, drug discovery and human identification.
The company supplies automation, sample extraction and diagnostic reagents around the world, and is scaling up manufacturing to address the raising demand for COVID-19 related tools.
Promega claimed that its reagents are currently being incorporated in 15 COVID-19 diagnostic tests produced by other diagnostic manufacturers across the world.
Recently, Bodysphere has secured the US FDA’s EUA for its new testing kit to diagnose COVID-19 within two minutes.
The new diagnostic test has been designed to use antibodies in blood to test for current or past infection.
