Applied BioCode announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance for the use of Roche MagNA Pure 96 Extraction System with its BioCode MDx-3000 and Gastrointestinal Pathogen Panel (GPP).
Image: Applied BioCode secures FDA approval for Roche MagNA Pure 96 Extraction System. Photo: Courtesy of the U.S. Food and Drug Administration.
Applied BioCode has recently secured FDA 510(k) clearance for the BioCode GPP and BioCode MDx-3000 System, using the bioMerieux NUCLISENS easyMAG extraction system.
With the addition of the MagNA Pure 96 System, the company is expected to gain access to higher volume laboratories that use the Roche system for sample extraction.
Applied BioCode said that its MagNA Pure 96 System is capable of extracting DNA/RNA from up to 96 patient samples in approximately 60mins.
In addition, the Roche MagNA Pure 96 System when combined with the BioCode MDx-3000 system would facilitate laboratories to easily process up to 188 patient samples in a single, 8-hour shift.
The comprehensive BioCode Gastrointestinal Pathogen Panel is designed to provide results for the 17 most common bacteria, viruses, and parasites that cause infectious diarrhea.
The panel is comprised of targets for bacteria including Campylobacter jejuni, C Campylobacter coli, Clostridium difficile toxin A&B, Salmonella spp., Shigella/Enteroinvasive E. coli, Shiga-like toxin producing E.coli, E. coli O157, Enterotoxigenic E.coli, Enteroaggregative E. coli, Vibrio parahaemolyticus, Vibrio spp. including Vibrio vulnificus and Vibrio cholerae, Yersinia enterocolitica.
It also has targets for viruses including norovirus group I/II, adenovirus 40/41, rotavirus A, and parasites like Giardia lamblia, Cryptosporidium types C. hominis, C. parvum, and Entamoeba histolytica.
The company has designed BioCode MDx-3000 system to offer high volume laboratory with an alternative to high cost, single use, cartridge-based molecular test systems.
BioCode MDx-3000 is a user-friendly automated system that also offers target masking capabilities within panels to address variation in test ordering patterns and potential changes in panel reimbursement.
Furthermore, the system is capable of processing up to 3 different multiplex panels on the same run and offers a user defined mode where laboratories are allowed to develop their own multiplex assays to run on the system.
Applied BioCode claims that its BioCode GPP was the first of many syndromic infectious disease panels developed for the BioCode MDx-3000 System