Promega master mix approved for use in CDC’s COVID-19 diagnostic panel

Promega Corporation said that its GoTaq Probe 1-Step RT-qPCR System is now available in Centers for Disease Control and Prevention COVID-19 diagnostic protocol for emergency use.

Available through the CDC’s Emergency Use Authorization (EUA), the Promega tool is an approved master mix option for the 2019-Novel Coronavirus Real-Time RT-PCR Diagnostic Panel of the CDC.

Recently, the FDA gave approval of an amendment to the CDC’s diagnostic COVID-19 assay that includes acknowledgement that Promega master mix is an approved amplification reagent for laboratories using the assay from the CDC. The assay protocol is used by several public health labs and clinical testing labs across the US and is referenced by various labs across the world.

Heather Tomlinson – Promega Director of Clinical Diagnostics 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 master mix approved for use in CDC’s COVID-19 diagnostic panel. Photo courtesy of Business Wire.

According to Promega, the GoTaq Probe 1-Step RT-qPCR System is a ready-to-use master mix of optimized components for strong RT-qPCR using hydrolysis probes.

Promega, which is engaged in providing automation, sample extraction, and diagnostic reagents across the world, commenced scaling up manufacturing in January to address the high demand for coronavirus related tools. The company’s reagents are also incorporated currently in 15 COVID-19 diagnostic tests produced by other major diagnostic manufacturers.