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…