Applied BioCode SARS-CoV-2 Assay Granted Emergency Use Authorization


The BioCode® SARS-CoV-2 Assay is a CLIA high-complexity multiplex nucleic acid assay for the qualitative detection of SARS-CoV-2 nucleic acids in respiratory samples including nasopharyngeal swabs, nasal swabs, oropharyngeal swabs and bronchoalveolar lavage from individuals who are suspected of COVID-19 by their healthcare provider. 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 COVID-19 testing needs. The BioCode® SARS-CoV-2 Assay is only for use under the Food and Drug Administration’s Emergency Use Authorization.

The BioCode® SARS-CoV-2 Assay is designed to detect 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 assays can provide CLIA high complexity laboratories with the capability to perform high throughput, efficient testing to meet testing needs. Furthermore, our multiplex BioCode® 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.”