GenoSensor COVID-19 RT-PCR KIT Granted FDA Emergency Use Authorization

GenoSensor Corporation (Tempe, AZ, USA) has received FDA Emergency Use Authorization (EUA) for its GS COVID-19 RT-PCR KIT which provides accurate, reproducible, high-quality results for clinical decision-making for patients with suspected COVID-19 (coronavirus) infection. With its high sensitivity detection (single copy detection) when run according to its instructions for use in a qualified clinical lab, it is one of the most sensitive tests currently available under an FDA EUA.

GenoSensor develops and delivers products and services for genomic research, drug discovery, predisposition gene screening, therapeutic assessment, and other bioscience applications. The company’s GS COVID-19 RT-PCR KIT is a molecular test specifically detecting the SARS-CoV-2 virus that causes COVID-19. The test is intended for the qualitative detection of nucleic acids from SARS-CoV-2 in nasopharyngeal and oropharyngeal swab samples from patients who meet the CDC SARS-CoV-2 clinical criteria.

The real-time reverse transcription polymerase chain reaction (RT-PCR) test detects three genes from the SARS-CoV-2 virus from clinical nasopharyngeal swab specimens. In addition, GenoSensor’s GS COVID-19 RT-PCR KIT also includes an internal positive control gene (GUSB) that serves as an extraction, reverse transcription, and PCR amplification control for each sample to minimize false negative results. The GS COVID-19 RT-PCR test runs on the Applied Biosystems 7500 Fast Dx Real-Time PCR Instrument and is available for the 96 well plate (22 clinical samples) and 384 well plate (94 clinical samples), with test results provided in less than 90 minutes.

“Beginning in the early days of the COVID-19 outbreak in Wuhan, China, GenoSensor has been working with our international and U.S. colleagues to develop a highly sensitive and highly specific diagnostic that will provide healthcare teams and public health professionals with the diagnostic data they need to help people today and in the future,” said Dr. James Xia, founder and President of GenoSensor Corporation. “The GS COVID-19 RT-PCR KIT has achieved this goal and is now available. We are grateful to the FDA for their assistance and for this Emergency Use Authorization. We also greatly appreciate the support we have received from members of our Arizona bioscience community throughout this process.”

“The GS COVID-19 RT-PCR KIT is a much-needed addition to the tool set that communities across the country are using to respond to the COVID-19 health emergency,” said Joan Koerber-Walker, President and CEO of AZBio. “The GenoSensor team has worked tirelessly to develop this test and obtain the FDA Emergency Use Authorization. Thanks to their committed efforts, more testing is now possible in Arizona and across the US.”

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