A Promega Corp. product received approval from the U.S. Food and Drug Administration to be used in the Centers for Disease Control and Prevention’s test for the new coronavirus.
The Fitchburg-based company announced Wednesday that one of its master mixes is approved under an FDA Emergency Use Authorization as an amplification reagent for the CDC-developed test. Promega’s master mix is one of four approved for use with the CDC test.
“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 director of clinical diagnostics Heather Tomlinson said in a statement.
The amplification master mix is one piece of the testing process, allowing scientists to make millions to billions of copies of RNA from one sample. Because it can increase the specific RNA of the new coronavirus, scientists can then study the sample in detail to determine whether the coronavirus is present.
“Think of a testing protocol as a puzzle. Each product used is like a piece that must fit together exactly,” Tomlinson said. “The CDC is looking for more pieces that work with this puzzle and still fit exactly. This gives labs more flexibility to use more approved options in the testing process.”
The CDC test is one of more than 20 approved by the FDA Emergency Use Authorization, and some states are also creating and validating their own tests. The CDC test is used by public health labs that work with the CDC.
The mix has been used in other tests for the coronavirus internationally since January. More than 50 other Promega products are also being used to test for coronavirus, Tomlinson said.
Promega materials support about 15 testing kits globally, such as the Logix Smart Coronavirus COVID-19 Test developed by Co-Diagnostics in Utah.
Promega ramped up production on several key materials used in the fight to story the coronavirus from spreading, the company said last month. It currently has the capacity to manufacture and ship the mix, but Tomlinson noted that future shipments may need to be allocated strategically “to ensure labs have enough to keep operating from week to week.”