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RapiPlex : A Rapid, Multiplex, Immunoassay platform for universal - - PowerPoint PPT Presentation
RapiPlex : A Rapid, Multiplex, Immunoassay platform for universal - - PowerPoint PPT Presentation
+ RapiPlex : A Rapid, Multiplex, Immunoassay platform for universal application at the Point of Care June 2013 RapiPlex: Introduction + + Unique wholly owned intellectual property + Up to 12 analyte Multiplex + Quantitative and/or Qualitative +
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Jim Merselis CEO Niamh O’Luanaigh COO Shane Moynihan Head of Engineering Jim Walsh Executive Chairman Diarmuid Flavin BD Advisor
Leadership Team
Greater than 100 years proven experience in the Diagnostics and Healthcare Industries:
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Unmet need for a versatile universal application POC Platform
RapiPlex
Versatile Multiplex IP Position Robust Manufacturing Convenient & Compact Accurate Rapid Low Cost
+ 5 patent families + FTO — Choate, Hall & Stewart (Boston) + Up to 12 analytes simultaneously + All immunoassay formats + Multiple biological samples + Small & large sample sizes (20μl to 1ml) + Simple to use + Designed for CLIA waiver + Volume-driven low cost per test + Results in 5 to15 minutes + Quantitative results + Qualitative results + No visual interpretation + Integrated & Automated batch calibration & controls + Compact reader footprint + Add sample, wait, read + No maintenance + Patient records + Robust manufacturing processes + IVD materials
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Demonstrated validated assays on RapiPlex
Drugs of Abuse Cardiac Markers + Test for the presence of a small molecule + Competitive assay format + Semi-quantitative / Qualitative + Saliva & urine samples + Demonstrates 2 analyte multiplexing Cocaine Amphetamime + Test for the presence of an complex protein + Sandwich assay format + Quantitative + Whole blood/serum/plasma sample + Demonstrates 2 analyte multiplexing CRP Myoglobin
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Biosensia Intellectual Property
+ 5 patent applications
Cartridge System Fluidics Overall Design of the Multiplex Cartridge Sampling Handling Methods Instrumentation
+ Nationalisation in EU, US, Japan, China, Australia & Ireland + FTO – Choate, Hall & Stewart – Boston
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RapiPlex: An Integrated sample to answer multi-faceted point of care platform
+ A Portfolio of Innovative technologies integrated into one universal platform 1. Fluidics cartridge 2. Immunodiagnostic assays 3. Integrated fluorescent reader + The RapiPlex system can be adapted to accurately measure any immunologically active substance
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Self Contained Single Use Cartridge
+ Integrated sample handling that simplifies user procedure + Multi channel configuration which facilitates testing across broad dynamic ranges + Each cartridge can house up to 12 test zones, detecting 1-12 Biomarkers from 1 Sample + User adds sample and ‘walks away’. Whole blood, serum, plasma, saliva, urine, stool samples and milk verified on the platform + Cartridge dimension 2” x 2.9” x 0.3” (base) and 0.8” (top) + Low cost to manufacture and assemble
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Reader: User Friendly Operation, Designed for CLIA Waiver
+ Universal reader for all assay cartridges + Simultaneous multiplex quantitative and/or qualitative analysis + Highly sensitive optical detection of fluorescence + Compact platform suitable for lab, clinical or field use + Portable – battery or mains power + Foolproof and failsafe automated operation + Intuitive software interface controls all aspects of the test, and requires only minimal intervention by user + Multiple connectivity options + Easy to use – insert cartridge and read
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Reader: Features
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+ Connectivity
LAN for data transfers USB for data export and updates Wi-Fi available Thermal transfer printer
+ On board data storage for > 5000 cartridge
scans
+ Field Updateable + Software Controls
Self check on start up Self testing & regulation during scan Integrated error reporting and notification Calibration Data & interval Multiple user levels
+ Multiplex up to 6 channels + Simple automated work flow + Results presented as they occur
Hard and soft copies
+ Integrated cartridge bar code reader
Lot specific calibration – lot and expiry
+ Optional wand bar code scanner + Large color 7” touch screen
Graphics, text and images possible Simple user interface
+ Compact Form Factor – 12” x 9.5” x 6” + Configurable to interface with LIMS
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RapiPlex: Graphic User Interface (selected screens)
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+ Screen colour design: GREY: Report or Prompt GREEN: Successful operation, attract attention AMBER: Alert RED: Warning! + Cartoon Instruction Graphics
Inform user of procedure Screen formats
QC Test Passed
Please Remove Cartridge
(Warning 231)
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RapiPlex: Graphic User Interface (selected screens)
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How RapiPlex fulfills customer requirements
Point of Care Customer Requirement RapiPlex
Good correlation of analytical results of a PoC with a lab system
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Analytical performance of a PoC system similar to lab system
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Whole blood as sample material (finger prick and venous)
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Fast Turn-Around-Time
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Small and large sample volume
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No system maintenance
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High operator convenience
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Simple Intuitive user interface
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Fool proof and failsafe operation
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Recent Publications & Press
+ Featured in Clinical Laboratory News October 2012 + Featured in IVD Technology June/July 2012 + AACC Oak Ridge Conference ‘Emerging Technologies for 21st Century Clinical Diagnostics 2012 Poster 1 “Evaluation of a multiplex drugs of abuse detection platform with integrated sample handling technologies” Poster 2 “RapiPlex a small volume whole blood quantitative microfluidic florescent point of care platform” + Featured in Clinica Medtech Ventures April 2012 + Featured in as ‘One to Watch’ in Irish Times Innovation Magazine August 2011
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Summary
+ Rapid, multiplexing, quantitative diagnostic platform + Versatile, easy to use and suitable for a use with a multitude of biological samples + Unique portfolio of IP + RapiPlex Platform is suited for application in a variety of growth POCT markets + Demonstrated expertise in the integration of fluidics, photonics and IVD assay’s + Strategic partnerships being sought to bring product to market
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