FDA Clearance and CL...
2nd October 2018 Content supplied by: Applied BioCode
Syndromic Gastrointestinal Pathogen Panel Approved by the FDA
Applied BioCode has received U.S. Food and Drug Administration 510(k) clearance for BioCode Gastrointestinal Pathogen Panel (GPP) with high throughput BioCode® MDx-3000 molecular system.
The comprehensive BioCode® Gastrointestinal Pathogen Panel tests for 17 most common bacteria, viruses, and parasites that cause infectious diarrhea. 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.
"We are honored to receive 510(k) clearance from the U.S. FDA for our Gastrointestinal Pathogen Panel with BioCode® MDx-3000 system," said President Winston Ho, Ph.D. "It marks a major milestone for our company and provides yet another validation for our digital Barcode Magnetic Bead technology. 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 cost to the healthcare. The Gastrointestinal Pathogen Panel is the first of many syndromic panels we expect to bring to our customers."
Date Published: 2nd October 2018
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