Skip to main content
Premium Trial:

Request an Annual Quote

Zymo Research Granted FDA Emergency Use Authorization for Coronavirus Molecular Kit

NEW YORK ─ The US Food and Drug Administration on Thursday granted Emergency Use Authorization to life science reagent company Zymo Research for its Quick SARS-CoV-2 rRT-PCR Kit for the detection of SARS-CoV-2 coronavirus.

The molecular kit, developed by the Irvine, California-based firm, has been authorized as a laboratory test for the detection of nucleic acid from SARS-CoV-2 in upper and lower respiratory specimens from patients suspected of COVID-19, the agency said.

Nucleic acid extraction and purification is performed manually or using the Zymo Research Quick-DNA/RNA Viral MagBead extraction kit on the automated Thermo Fisher KingFisher Flex Purification System.

The Quick SARS-CoV-2 rRT-PCR Kit runs on the Bio-Rad CFX96 Touch real-time PCR detection system, according to the FDA's instructions for use. SARS-CoV-2 nucleic acid is extracted, isolated, and purified from patient specimens, and the purified nucleic acid is reverse transcribed into cDNA prior to PCR amplification and detection using the real-time PCR instrument.