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GenoSensor Granted FDA Emergency Use Authorization for High Throughput COVID-19 RT-PCR Diagnostic for Use in U.S.

April 20, 2020 Off By BusinessWire

FDA Emergency Use Authorization for the GS™ COVID-19 RT-PCR KIT was issued on April 16, 2020. View FDA Letter: https://www.fda.gov/media/137090/download
With a high sensitivity detection (single copy detection) when run according to its instructions for use in a qualified clinical lab, the GS™ COVID-19 RT-PCR test is one of the most sensitive tests currently available under an FDA Emergency Use Authorization.
GS™ COVID-19 RT-PCR KIT 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.

TEMPE, Ariz. & CHANDLER, Ariz.–(BUSINESS WIRE)–#Arizona–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% 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.

About SARS-CoV-2 (coronavirus) and COVID-19

Coronaviruses (CoV) are a large family of viruses that cause illness ranging from the common cold to more severe diseases such as Middle East Respiratory Syndrome (MERS-CoV), Severe Acute Respiratory Syndrome (SARS-CoV) and COVID-19 (SARS-CoV-2), a new coronavirus strain which has not previously been identified in humans. To learn more about SARS-CoV-2 (coronavirus) and COVID-19 please visit Coronavirus.gov.

About GenoSensor Corporation

GenoSensor Corporation is a genomic technology company, aiming to improve human healthcare by developing and marketing products and services for genomic research, drug discovery, predisposition gene screening, therapeutic assessment and other bioscience applications. GenoSensor’s focus is to provide products and services to customers who conduct genomic research and/or are in needs of genomic solutions in all life sciences. The company also develops assays for specific applications. To learn more, visit www.genosensorcorp.com.

About Arizona Bioindustry Association, Inc. (AZBio)

For 17 years, the Arizona Bioindustry Association (AZBio) has supported life science innovation and life science innovators in Arizona. A key component in Arizona’s life science ecosystem, AZBio is the only statewide organization exclusively focused on Arizona’s bioscience industry. AZBio membership includes patient advocacy organizations, life science innovators, educators, healthcare partners and leading business organizations. AZBio is the statewide affiliate of the Biotechnology Innovation Organization (BIO) and works in partnership with AdvaMed, MDMA, and PhRMA to advance innovation and to ensure that the value delivered from life-changing and life-saving innovation benefits people in Arizona and around the world.

For more information visit www.AZBio.org.