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

Applied BioCode, Inc. (Santa Fe Springs, CA, USA) has secured Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for its BioCode SARS-CoV-2 Assay.

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. It 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 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 eight-hour shift) to help address COVID-19 testing needs. 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. “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.”

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Applied BioCode, Inc.