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

SANTA FE SPRINGS, Calif.--(BUSINESS WIRE)--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.”

For more information on the BioCode® SARS-CoV-2 Assay, visit: www.apbiocode.com

About Applied BioCode

Applied BioCode is an IVD manufacturer that designs, develops, and commercializes multiplex testing products. The company has combined “digital barcodes” with immuno- and molecular chemistry to create a new, bio-inspired Barcoded Magnetic Beads (BMB) technology. The micro BMBs, about the diameter of a human hair, are tagged with immunochemistry or molecular probes, allowing the digital barcodes to be easily scanned and accurately identified up to 4,096 barcodes with no ambiguity for biological targets. The BioCode® Respiratory (17-plex) Pathogen Panel and Gastrointestinal (17-plex) Pathogen Panel based on the BioCode® MDx-3000 automated system have been cleared for use in the US by the FDA . Applied BioCode also partners with a variety of diagnostic companies with applications that include the infectious disease, autoimmune disease, allergy, gut microbiome, and veterinary markets.