Press Release: Applied BioCode's Syndromic Gastrointestinal Pathogen Panel Approved by the FDA
Oct 15, 2018
Los Gatos, CA - Ximedica client Applied BioCode announced that it has received 510(k) clearance from the U.S. Food and Drug Administration for their BioCode Gastrointestinal Pathogen Panel (GPP) with high throughput BioCode® MDx-3000 molecular system.
The clearance was awarded after the successful completion of a clinical study that included more than 1,558 prospective samples, archived positives, and contrived samples. Applied BioCode had previously received CE Mark Certification for commercial distribution in May 2018. The comprehensive BioCode® Gastrointestinal Pathogen Panel tests for 17 of the most common bacteria, viruses, and parasites that cause infectious diarrhea. The BioCode® MDx-3000 system automates the PCR amplification, hybridization/target capture, and detection steps of molecular diagnostic testing. The system allows laboratories in medium to large-sized hospitals to run automated large multiplexed panels - leading to better patient outcomes, improved lab efficiencies, and overall lowered healthcare costs.
Applied BioCode partnered with Ximedica on the development of a barcoded magnetic bead platform, using Ximedica’s modular engineering and design approach, rapid prototyping capability, and manufacturing launch expertise to create a novel IVD instrument.
About Applied BioCode
Applied BioCode is a publicly traded diagnostic company that develops, manufactures, and markets Barcoded Magnetic Beads (BMBs) and detection systems to facilitate the development of highly multiplexed nucleic acids or protein detection assays. The BMB technology offers up to 4,096 unique digital barcodes for multiplex analysis with unmatched decoding accuracy. Our easy-to-use BioCode® systems employ steady state detection without requiring flow cytometers that are prone to channel blockage or sample cross-contamination. The system is well suited for clinical diagnostic applications such as detection of pathogens, drug resistance markers, cancer markers & mutation analysis, as well as specific applications for the life science research and agricultural testing markets. For more information, please visit the company’s website at www.apbiocode.com.
Ximedica is a full-service ISO 13485-certified and FDA-registered medical device and diagnostics product development firm. For 30 years Ximedica has provided a unique growth platform enabling organizations to successfully deploy medical technology products into the market. Its headquarters are in Providence, R.I., with offices in Hong Kong, Minneapolis, San Francisco and Silicon Valley. In November of 2014, SV LifeSciences, a Boston-based private equity firm, acquired a majority stake in Ximedica, enabling the company to execute its growth strategy. For more about Ximedica, visit http://www.ximedica.com/.