Applied BioCode Receives CE Mark Certification for BioCode® MDx 3000 with 18-plex Gastrointestinal Pathogen Panel

SANTA FE SPRINGS, Calif. –(BUSINESS WIRE)– Applied BioCode announced today that they have received CE mark certification for the BioCode® MDx 3000 with 18-plex Gastrointestinal Pathogen Panel. This will allow commercial distribution of the first MDx 3000 systems in Europe as well as in all countries recognizing the CE mark.

“We are extremely pleased to receive the CE mark certification for our BioCode® MDx 3000 system with 18-plex Gastrointestinal Pathogen Panel,” said Winston Ho Ph.D. “Our system will help hospitals and clinical laboratories to provide high volume syndromic testing to their patients at a more affordable cost. The GI Pathogen Panel is the first of many syndromic panels we expect to bring to our customers.”

The BioCode® MDx 3000 utilizes proprietary Barcoded Magnetic Beads and automates the PCR amplification, hybridization/ target capture and detection processes of molecular diagnostic testing. The system can process up to 94 samples in about 3.5 hours, or up to 3,384 results in an 8-hour shift. The automated system was designed to reduce hands-on time, maximize test throughput, and minimize the potential for sample contamination. It has the ability to process up to 3 different assay panels on the same run and provides the capability to automatically mask any test results within individual panels for tests not ordered on the patient. Based on the 96-well microplate, the system offers both throughput advantages and cost savings compared to cartridge-based systems. The MDx 3000 system also offers a User Defined Mode where laboratories can develop their own multiplex assays to run on the system.

The BioCode® 18-plex Gastrointestinal Pathogen Panel (GPP) includes the most common pathogenic bacteria, viruses, and parasites. The BioCode® GPP includes targets for the bacteria (Campylobacter, Clostridium difficile toxin A&B, Salmonella, Shigella, Shiga toxin producing E.coli, E. coli O157, Enterotoxigenic E.coli, Enteropathogenic E. coli, Enteroaggregative E. coli, Vibrio parahaemolyticus, Vibrio spp., (Vibrio vulnificus, Vibrio cholerae), Yersinia enterocolitica), viruses (norovirus group I/II, adenovirus 40/41, rotavirus A), and parasites (Giardia, Cryptosporidium, Entamoeba histolytica).