SANTA FE SPRINGS, Calif.–(BUSINESS WIRE)–
The BioCode® SARS-CoV-2 Assay is a multiplex nucleic acid assay for the qualitative detection of SARS-CoV-2 nucleic acids in nasopharyngeal swabs and bronchoalveolar lavage. The BioCode® SARS-CoV-2 runs on the BioCode® MDx-3000, an automated molecular diagnostic system. BioCode® SARS-CoV-2 Assay can deliver up to 564 sample results in a day (188 sample results in an 8 hour shift) to help address the testing needs. Applied BioCode has submitted the notification to the U.S. Food and Drug Administration (FDA) for release of the test under Emergency Use Authorization (EUA).
The BioCode® SARS-CoV-2 Assay is designed to provide 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 our FDA-cleared BioCode® Respiratory Pathogen Panel for a more complete respiratory infection profile of patients.
“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,” said Dr. Winston Ho, Ph.D., Applied BioCode’s President. He further commented, “Our automated assay can provide CLIA high complexity laboratories with the capability to perform high throughput, walk away testing to meet the testing needs. 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.”