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

Applied BioCode declared 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 identifying the CE mark.

“We are very 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 support hospitals and clinical laboratories to provide high volume syndromic testing to their patients at a more reasonable cost. The GI Pathogen Panel is the first of many syndromic panels we expect to bring to our clients.”

The BioCode MDx 3000 utilizes proprietary Barcoded Magnetic Beads and automates the PCR amplification, hybridization/ target capture and detection procedures of molecular diagnostic testing. The system can procedure 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 decrease hands-on time, maximize test throughput, and minimize the potential for sample contamination. It has the ability to procedure 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.

 

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