Applied BioCode Submits 510(k) Application to FDA for BioCode MDx-3000 with Gastrointestinal Pathogen Panel

SANTA FE SPRINGS, Calif.–(BUSINESS WIRE) — Applied BioCode announced today that it has submitted the BioCode MDx-3000 with 18-Plex Gastrointestinal Pathogen Panel (GPP) to the U.S. Food and Drug Administration (FDA) for 510(k) clearance.

The BioCode MDx-3000 system was designed for high volume molecular testing in large hospitals and reference laboratories. The system automates the PCR amplification, hybridization/target capture, and detection steps of molecular diagnostic testing. It provides laboratories with the ability to run highly multiplexed panels which improves lab efficiency, reduces labor and reagent cost, minimizes sample contamination, and may result in better patient outcomes.

The BioCode MDx-3000 system offers the high volume laboratory an alternative to high cost molecular test systems. The user-friendly system also offers target masking capabilities within panels to address variation in test ordering patterns and potential changes in panel reimbursement. Bi-directional data integration to laboratory information systems simplifies laboratory processes and reduces transcription errors.

The comprehensive BioCode GPP tests for 18 of the most common bacteria, viruses, and parasites that cause infectious diarrhea. The submission of the BioCode GPP comes after the successful completion of a clinical study that included more than 1,550 prospective samples. The study was conducted at several hospital-based clinical laboratories located in different geographical areas in the United States. Applied BioCode anticipates commercial release of the BioCode MDx-3000 with GPP in the early spring of 2018, pending FDA clearance.

Dr. Winston Ho, Ph.D., Applied BioCode’s President, said: “Feedback from our U.S. clinical trial sites has been extremely positive and reinforces the need for a more automated high throughput multiplex molecular test system. 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, “The Gastrointestinal Pathogen Panel will be the first of many syndromic multiplex panels to be commercialized on the BioCode MDx-3000.”