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FDA Clears Roche Extraction Platform For Use With Applied BioCode GI Pathogen Panel, System

NEW YORK (360Dx) – Applied BioCode said today that it has received US Food and Drug Administration 510(k) clearance for the use of the Roche MagNa Pure 96 Extraction System with the high-throughput BioCode MDx-3000 and BioCode Gastrointestinal Pathogen Panel.

Applied BioCode said that the clearance gives it access to higher volume laboratories that use the Roche MagNa Pure 96 System for sample extraction. The MagNa Pure 96 System purifies DNA, RNA, and viral nucleic acids from starting materials using magnetic glass particle technology. It extracts DNA/RNA from up to 96 patient samples in about one hour.

Combining the BioCode MDx-3000 system and the Roche MagNa Pure 96 System will allow laboratories to process up to 188 patient samples in a single, eight-hour shift, Applied BioCode said.

Santa Fe Springs, California-based Applied BioCode said its gastrointestinal pathogen panel provides results for the 17 most common bacteria, viruses, and parasites that cause infectious diarrhea. The panel includes targets for Campylobacter (C. jejuni and C. coli)Clostridium difficile toxin A&B, Salmonella spp.Shigella/Enteroinvasive E. coli, Shiga-like toxin producing E.coliE. coli O157, Enterotoxigenic E.coli, Enteroaggregative E. coliVibrio parahaemolyticusVibrio spp. (including Vibrio vulnificus and Vibrio cholerae), Yersinia enterocolitica, viruses: norovirus group I/II, adenovirus 40/41, rotavirus A, and parasites: Giardia lambliaCryptosporidium (C. hominis and C. parvum), and Entamoeba histolytica.

The firm said that its MDx-3000 system offers the high-volume laboratory an alternative to high-cost, single use, cartridge-based molecular test systems, and can process up to three different multiplex panels on the same run.

The FDA recently cleared use of the BioMérieux Nuclisense EasyMag extraction system with BioCode's gastrointestinal pathogen panel and MDx-3000 system.