Applied BioCode’s MDx-3000 Cleared for GI Pathogen Detection

October 8th, 2018 Editors Pathology

Applied BioCode, a company based in Santa Fe Springs, California, landed FDA clearance for its BioCode MDx-3000 molecular system for testing for 17 common gastrointestinal pathogens, including bacteria, viruses, and parasites. Clearance was based in part on a multi-center clinical study involving over 1,500 samples.

The device is intended for medium to high volume clinical and reference labs, automating PCR amplification, hybridization/target capture, and detection. The system, using the BioCode Gastrointestinal Pathogen Panel, can provide results from 94 samples in around 3.5 hours and 3,196 samples within 8 hours thanks to parallel processing.

Some features of the new device:

Automation of key system processes (amplification, hybridization, detection) reduces hands on time and the potential for sample contamination

Highly Multiplex Assays can have up to 100 different primers

Operators can program the system to suppress results for tests not ordered on the patient

Operators can run the same panel or mix different panels with the same protocols on one plate

Reagents are barcoded with test Type, Lot Number, and Expiration Date information

All results are available for transfer to the LIS after each run is completed

Automatic System Decontamination with UV light is performed after the sample process is completed and samples are removed

Product page: BioCode MDx 3000 System…

Via: Applied BioCode…

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