NEW YORK (GenomeWeb) – Applied BioCode announced today that it has received CE mark certification for its BioCode MDx 3000 molecular testing platform and Gastrointestinal Pathogen Panel (GPP).
The BioCode MDx-3000 is a high-volume, automated PCR-based molecular diagnostics platform designed for use by large hospitals and reference labs. The system can process up to 94 samples in about 3.5 hours, or up to 3,384 results in an 8-hour shift, the Santa Fe Springs, California-based firm said.
The GPP tests for nucleic acids of 18 common bacteria, viruses, and parasites that cause infectious diarrhea.
Earlier this year, Applied BioCode submitted the platform and test to US regulators for clearance.
"Our system will help hospitals and clinical laboratories to provide high-volume syndromic testing to their patients at a more affordable cost," Applied BioCode President Winston Ho said in a statement. "The GI Pathogen Panel is the first of many syndromic panels we expect to bring to our customers."
Applied BioCode is developing additional infectious disease tests including ones for respiratory and sexually transmitted infections.