GenoSensor’s High-Throughput COVID-19 RT-PCR Diagnostic Granted FDA EUA

GenoSensor Corporation has received FDA Emergency Use Authorization for the GS COVID-19 RT-PCR KIT.
 
GenoSensor Corporation (GenoSensor) is a genomic technology company based in Tempe, Arizona that develops and delivers products and services for genomic research, drug discovery, predisposition gene screening, therapeutic assessment, and other bioscience applications. GenoSensor has been supporting researchers, educators, and laboratories since 2003 and is a member of the Arizona Bioindustry Association (AZBio).
 
“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,” stated 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,” stated 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 U.S.”
 
The GS COVID-19 RT-PCR KIT
The GS COVID-19 RT-PCR KIT provides accurate, reproducible, high-quality results for clinical decision-making for patients with suspected COVID-19 (coronavirus) infection.
 
The GS COVID-19 RT-PCR test 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 test has a full-process positive, negative and internal controls.
 
The GS COVID-19 RT-PCR test is a real-time reverse transcription polymerase chain reaction (RT-PCR) test which detects three genes from the SARS-CoV-2 virus from clinical nasopharyngeal swab specimens. In addition, the 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 KIT provides:
 

• Accuracy: Assay 3 target genes unique to SARS-CoV-2 having higher specificity and exhibiting lower risk for mutation
• Specificity: Targeted specificity to 100 percent of currently available complete genomes for SARS-CoV-2.
• Simplicity: Ready to use all-in-one master mix reagents and controls minimize variability
• Throughput: Two kit package options of viral detection for up to 94 specimens
• High quality, high performance and reliability

 
The GS COVID-19 RT-PCR test runs on the Applied Biosystems 7500 Fast Dx Real-Time PCR Instrument. Kits are available for the 96 well plate (22 clinical samples) and 384 well plate (94 clinical samples) and provides test results in less than 90 minutes.
 
The GS COVID-19 RT-PCR KIT is intended for use by trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures. Instructions for use, the FDA EUA letter, and other documentation is provided at GenoSensorCorp.com.
 
The GS COVID-19 RT-PCR KIT has not been cleared or approved by the FDA. However, it has been authorized by the FDA under an EUA. The test has been authorized only for the detection of RNA from SARS-CoV-2 virus to aid in the diagnosis of SARS-CoV-2 virus infection, not for any other viruses or pathogens. The test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.