NEW YORK (GenomeWeb) – Applied BioCode said today that it has received US Food and Drug Administration 510(k) clearance for the BioCode Gastrointestinal Pathogen Panel (GPP) with the BioCode MDx-3000 molecular system.
The BioCode GPP tests for 17 of the most common bacteria, viruses, and parasites that cause infectious diarrhea. It runs on the BioCode MDx-3000, which automates PCR amplification, hybridization/target capture, and detection, and can process up to 94 samples in about 3.5 hours or generate up to 3,196 results in an eight-hour shift, Applied BioCode said.
FDA clearance was based on the results of a clinical study of more than 1,558 prospective samples, archived positives, and contrived samples at multiple hospital-based clinical laboratories around the US.
The clearance "marks a major milestone for our company and provides yet another validation for our digital barcode magnetic bead technology," Applied BioCode President Winston Ho said in a statement. "Our BioCode MDx-3000 system will help medium to large hospitals and clinical laboratories provide automated high-volume syndromic testing to their patients at a lower overall [heathcare] cost."
Ho also noted that the GPP is the first of many syndromic panels the company expects to make available for the system.