The new BioCode SARS-CoV-2 has been designed to run on the BioCode MDx-3000, an automated molecular diagnostic system
US-based biotechnology company Applied BioCode introduces BioCode SARS-CoV-2 Assay, a multiplex nucleic acid assay for the qualitative detection of SARS-CoV-2 nucleic acids in nasopharyngeal swabs and bronchoalveolar lavage.
The new BioCode SARS-CoV-2 has been designed to run on the BioCode MDx-3000, an automated molecular diagnostic system.
The new SARS-CoV-2 Assay is capable of delivering up to 564 sample results in a day, providing 188 sample results within an 8 hour, to address the testing needs.
Applied BioCode president Winston Ho said: “We are extremely pleased to provide our BioCode SARS-CoV-2 Assay with the high throughput automated MDx-3000 system to help with the fight against the COVID-19 pandemic.
“Our automated assay can provide CLIA high complexity laboratories with the capability to perform high throughput, walk away testing to meet the testing needs.
Applied BioCode seeks the US FDA Emergency Use Authorization (EUA) for the new test
Applied BioCode has submitted the notification to the US Food and Drug Administration (FDA) for release of the test under Emergency Use Authorization (EUA).
The BioCode SARS-CoV-2 Assay is said to deliver accurate results by detecting two different regions of the SARS-CoV-2 virus N gene which are also utilized by the CDC EUA assay.
The assay can be run as an independent assay or in parallel with the FDA approved BioCode Respiratory Pathogen Panel for a more complete respiratory infection profile of patients.
The company has secured FDA-510K approvals for Respiratory 17-plex Pathogen Panel and Gastrointestinal 17-plex Pathogen Panel based on its BioCode MDx-3000 automated system.
Winston Ho added: “Furthermore, our multiplex respiratory pathogen panel offers comprehensive tests combined with flexible ordering and reporting capabilities. We are very proud of our company’s ability to respond to this crisis and are committed to provide sensitive and reliable diagnostic information to laboratorians to better manage their patients.”
Applied BioCode is an in vitro diagnostic device (IVD) manufacturer engaged in designing, developing, and commercialising multiplex testing products.