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Gene By Gene is set to launch a diagnostic test to detect nucleic acid from the SARS-CoV-2 virus that causes Covid-19 infection in response to the global pandemic.
The molecular-based assay that detects viral RNA in respiratory specimens is designed to deliver patient results within 24 hours of a specimen arriving at the Gene By Gene lab. The company expects to ramp up the sample processing to 7,000 tests a week later this month.
Gene By Gene president and CEO Bennett Greenspan said: “We were confident we could answer the call for additional testing capabilities in the US to help combat the spread of the Covid-19 outbreak.
“Thanks to the determination and swift action of our dedicated staff, including a team of highly experienced lab professionals, Gene By Gene will aid medical personnel in their efforts to quickly identify and treat patients who are ill through our quality testing services.”
The company said that it will not collect respiratory specimens of suspected Covid-19 cases.
Specimens will be processed at the company’s Level II Biosafety Laboratory and are required to be collected by a qualified healthcare professional in a healthcare facility or other suitable environment.
Gene By Gene performs the Covid-19 RNA test in accordance with the Centers for Disease Control and Prevention (CDC) and the US Food and Drug Administration (FDA) guidelines for assay validation and implementation.
The test is yet to receive emergency use authorisation (EUA) from the FDA. It is currently available to authorised healthcare providers in the US for the detection of nucleic acid from SARS-CoV-2.