Genomic technology company GenoSensor has secured emergency use authorisation (EUA)) from the US Food and Drug Administration (FDA) for its GS COVID-19 real-time reverse transcription-polymerase chain reaction (RT-PCR) diagnostic kit.

The high throughput kit has been developed to deliver precise and reproducible quality results for clinical decision-making for patients with suspected COVID-19 infection.

GenoSensor’s molecular test will help identify the SARS-CoV-2 virus that is responsible for COVID-19 disease

The GS COVID-19 RT-PCR test is a molecular test, which is designed to identify the SARS-CoV-2 virus that results in novel coronavirus disease.

GenoSensor’s test facilitates 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 GS COVID-19 RT-PCR test is provided with full-process positive, negative and internal controls.

The test enables to identify three genes from the SARS-CoV-2 virus from clinical nasopharyngeal swab specimens.

GenoSensor’s kit is also comprised of an internal positive control gene (GUSB), which acts as an extraction, reverse transcription and PCR amplification control for each sample to reduce false negative results.

The Applied Biosystems 7500 Fast Dx real-time PCR instrument will be used to run the GS COVID-19 RT-PCR test.

The kit, which generates test results within 90 minutes, is available for the 96 well plate (22 clinical samples) and 384 well plate (94 clinical samples).

GenoSensor founder and president Dr James Xia said: “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.

“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.”

Recently, the FDA has granted EUA status for saliva-based COVID-19 test. The EUA status allows the immediate use of saliva in COVID-19 testing exclusively applying the Spectrum SDNA-1000 saliva collection device, which enables to protect and preserve RNA used to detect infection.