Applied BioCode Submits FDA 510(k) Application for Syndromic BioCode® Respiratory Pathogen Panel

SANTA FE SPRINGS, Calif.–(BUSINESS WIRE)–Applied BioCode announced today that it has submitted the BioCode® Respiratory Pathogen Panel (RPP) for use on the BioCode® MDx-3000 Molecular System to the U.S. Food and Drug Administration (FDA) for 510(k) clearance. The BioCode® RPP tests nasopharyngeal swabs for 20 of the most common viruses and bacteria that cause upper respiratory infections. The submission of the BioCode® RPP comes after the successful completion of a clinical study that included more than 2,600 prospective samples at five clinical laboratories located in different geographical areas in the United States. The BioCode® RPP is intended for detection and differentiation of viruses and bacteria which include Influenza A and subtypes: H1, H1N1 2009pdm and H3, Influenza B, Respiratory Syncytial Virus A/B, Parainfluenza virus types 1, 2, 3, and 4, Human Metapneumovirus A/B, Rhinovirus/Enterovirus, Coronavirus OC43, HKU1, NL63, 229E, Adenovirus, Mycoplasma pneumoniae, Chlamydia pneumoniae, and Bordetella pertussis. Applied BioCode anticipates commercial release of the BioCode® Respiratory Pathogen Panel in December 2019, pending FDA clearance.

The BioCode® MDx-3000 system is designed for high volume, multiplex molecular testing at large hospitals and reference laboratories. The automated walk-away system performs up to 188 samples in an 8-hour shift and offers high volume laboratories an alternative to high cost, low throughput cartridge-based molecular test systems. It provides laboratories with the capability to run syndromic panels which improves lab workflow, reduces labor and cost to help provide better patient outcomes. The user-friendly system also offers “flexible target masking” capabilities within panels to address variation in test ordering patterns and potential changes in reimbursement.

Dr. Winston Ho, Ph.D., Applied BioCode’s President, said that “Feedback from our U.S. clinical trial sites has been positive, and reinforces the need for an automated high throughput multiplex MDx system, especially during flu season. The clinical trial sites were very pleased with the ease-of-use of the BioCode system and their ability to quickly train their staff on the system.” He followed on to say that “In addition to the 17-target BioCode® Gastrointestinal Pathogen Panel, which gained FDA clearance in 2018, the BioCode® Respiratory Pathogen Panel will be the second of many syndromic multiplex panels to be commercialized on the BioCode® MDx-3000.”

About Applied BioCode

Applied BioCode is an IVD manufacturer that designs, develops, manufactures, 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 BMB, with a diameter of human hair, is tagged with immunochemistry or molecular probes, allowing the digital barcode to be easily scanned and accurately identified for a very high number (4,096 barcodes) of biological targets with no ambiguity. 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. The BioCode® MDx-3000 system with GPP has obtained the CE-Mark for use in European countries, and is U.S. FDA cleared.

Contacts

Applied BioCode

Dr. Winston Z. Ho

President

1-833-246-2633