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.