3 October 2018 - - US-based diagnostic company Applied BioCode has received US Food and Drug Administration 510(k) clearance for BioCode Gastrointestinal Pathogen Panel with high throughput BioCode MDx-3000 molecular system, the company said.
The comprehensive BioCode Gastrointestinal Pathogen Panel tests for 17 most common bacteria, viruses, and parasites that cause infectious diarrhea.
Applied BioCode said the clearance of the BioCode GPP comes after the successful completion of a clinical study that included more than 1,558 prospective samples, archived positives and contrived samples. The study was conducted at multiple hospital-based clinical laboratories located in different geographical areas of the United States.
The BioCode MDx-3000 system was designed for medium to high volume molecular testing in large hospitals and reference laboratories.
The system automates the PCR amplification, hybridization/target capture, and detection steps of molecular diagnostic testing.
It provides laboratories with the capability to run highly multiplexed panels which improves lab efficiency, reduces labor and reagent cost, minimizes contamination, and may result in better patient outcomes.
The BioCode MDx-3000 system offers the high-volume laboratories with an alternative to high cost, single use, cartridge based molecular test systems.
The automated walk away system can process up to 94 samples in about 3.5 hours or up to 3,196 results in an 8-hour shift. The user-friendly system also offers result masking capabilities within panels to address variation in test ordering patterns and potential changes in panel reimbursement.
The BioCode MDx-3000 system has the capability to process up to 3 different syndromic panels on the same run and also offers a User Defined Mode where laboratories can develop their own multiplex assays to run on the system.
Applied BioCode develops, manufactures, and commercializes multiplex testing products. The company has combined "digital barcodes" with immunochemistry and molecular probes to create a new, bio-inspired Barcoded Magnetic Beads technology.
The microscale BMB, with a diameter of human hair, is tagged with immunochemistry or molecular probes, allowing the digital barcode to be easily scanned and accurately identified for very high number (4,096 barcodes) of biological targets with no ambiguity.
The company products will focus on the molecular infectious disease segment of the market with assays that detect pathogens for gastrointestinal infections, respiratory infections and others.
Applied BioCode also partners with a variety of diagnostic companies with applications that include the infectious disease, autoimmune disease, allergy, gut microbiome, and veterinary markets. The BioCode MDx 3000 system with GPP panel has also obtained the CE-Mark for use in European countries conforming to CE-Mark regulations.