BioCode® Gastrointestinal Pathogen Panel with an Efficient, Automated MDx-3000 System
Michael Aye, Ph.D. Applied BioCode
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Chapters
Introduction
Agenda
Applied BioCode, Inc. - Company Background
Applied BioCode, Inc. - Company Milestones
Barcoded Magnetic Beads (BMB): Digital Technology
BMB Composition & Fabrication: Semiconductor Fabrication method
Application of BMB Technology - Biochemistry for Nucleic Acids and Protein Detection
Multiplex Detection Method - Schematic for endpoint PCR detection using BMB
Application of BMB Technology - Optical Imaging & Detection
Applied BioCode Technology - Multiplex Applications/Capabilities
BioCode MDx 3000 – Automation
BioCode GPP: Scalable Workflow with MDx 3000
MDx 3000 Automation in action
Gastrointestinal Pathogen Tests
Gastrointestinal Pathogen Panel (GPP)
BioCode GI Pathogen Panel
BioCode MDx 3000: GPP Intra-Assay Variability
BioCode GI Pathogen Panel: Limit of Detection (Bacteria)
BioCode GI Pathogen Panel: Limit of Detection (Viruses & Parasites)
BioCode GPP Clinical Trials: 4 geographically distinct sites (1,558 prospective samples)
BioCode GI Pathogen Panel: Reproducibility at 3 clinical sites
BioCode GPP Clinical Trials: Reference Methods
BioCode GPP Clinical Trials - Clinical Performance: Campy & C. difficile
BioCode GPP Clinical Trials - Clinical Performance: Salmonella & Shigella/ EIEC
BioCode GPP Clinical Trials - Clinical Performance: STEC & E. coli O157
BioCode GPP Clinical Trials - Clinical Performance: EAEC & ETEC
BioCode GPP Clinical Trials - Clinical Performance: Vibrio spp & Yersinia enterocolitica
BioCode GPP Clinical Trials - Clinical Performance: Viruses
BioCode GPP Clinical Trials - Clinical Performance: Parasites
BioCode GPP Clinical Trials - Clinical Performance: Archived Positives
BioCode GPP Clinical Trials - Clinical Performance: Contrived Samples
BioCode GPP Clinical Trials - Clinical Performance: Invalid Rate
BioCode GPP Clinical Trials - Clinical Performance: Mixed Infections/ Co-detection
BioCode GPP 510(k) - Package Insert Limitations
BioCode GPP- Scalable Workflow with MDx 3000
BioCode GPP - High-throughput Workflow with MDx 3000
BioCode GPP - Workflow with MDx 3000
BioCode GPP Extraction Comparison - easyMAG & MagNA Pure 96
BioCode GPP (Internal Control) - easyMAG & MagNA Pure 96
Future Panel - Respiratory Panel (Nasopharyngeal Swab)
BioCode Respiratory Pathogen Panel
Applied BioCode MDx 3000 - Key System features
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