+ 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 + Simple Intuitive User Interface + Versatility, Portability and Ease of Use built in + M ultiple diagnostic applications + Low cost of goods 2
Leadership Team + Greater than 100 years proven experience in the Diagnostics and Healthcare Industries: Jim Merselis CEO Niamh O ’ Luanaigh COO Shane Moynihan Head of Engineering Jim Walsh Executive Chairman Diarmuid Flavin BD Advisor 3
Unmet need for a versatile universal application POC Platform + 5 patent families + FTO — Choate, Hall & Stewart (Boston) + Robust manufacturing processes IP Position + IVD materials + Up to 12 analytes Robust Multiplex simultaneously Manufacturing + All immunoassay formats + Compact reader footprint Convenient + Multiple biological samples RapiPlex + Add sample, wait, read & Versatile + Small & large sample sizes Compact + No maintenance (20 μ l to 1ml) + Patient records + Simple to use + Designed for CLIA waiver + Quantitative results Accurate Low Cost + Qualitative results + No visual interpretation + Volume-driven low cost per test Rapid + Integrated & Automated batch calibration & controls + Results in 5 to15 minutes 4
Demonstrated validated assays on RapiPlex Cardiac Markers Drugs of Abuse + Test for the presence of an complex protein + Test for the presence of a small molecule + Sandwich assay format + Competitive assay format + Quantitative + Semi-quantitative / Qualitative + Whole blood/serum/plasma sample + Saliva & urine samples + Demonstrates 2 analyte multiplexing + Demonstrates 2 analyte multiplexing CRP Cocaine Amphetamime Myoglobin
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
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 7
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 8
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 9
Reader: Features + + Connectivity + Multiplex up to 6 channels + Simple automated work flow LAN for data transfers USB for data export and updates + Results presented as they occur Wi-Fi available Hard and soft copies Thermal transfer printer + Integrated cartridge bar code reader + On board data storage for > 5000 cartridge Lot specific calibration – lot and expiry scans + Optional wand bar code scanner + Field Updateable + Large color 7 ” touch screen + Software Controls Graphics, text and images possible Self check on start up Simple user interface Self testing & regulation during scan + Compact Form Factor – 12 ” x 9.5 ” x 6 ” Integrated error reporting and notification + Configurable to interface with LIMS Calibration Data & interval Multiple user levels 10
RapiPlex: Graphic User Interface (selected screens) + 11
RapiPlex: Graphic User Interface (selected screens) + + Screen colour design: GREY : Report or Prompt GREEN : Successful operation, attract attention (Warning 231) AMBER : Alert RED : Warning! + Cartoon Instruction Graphics Inform user of procedure QC Test Passed Please Remove Cartridge Screen formats 12
How RapiPlex fulfills customer requirements + Point of Care Customer Requirement RapiPlex Good correlation of analytical results of a PoC with a lab system √ Analytical performance of a PoC system similar to lab system √ √ Whole blood as sample material (finger prick and venous) Fast Turn-Around-Time √ Small and large sample volume √ No system maintenance √ High operator convenience √ √ Simple Intuitive user interface Fool proof and failsafe operation √ 13
Recent Publications & Press + + Featured in Clinical Laboratory News October 2012 + Featured in IVD Technology June/July 2012 + AACC Oak Ridge Conference ‘ Emerging Technologies for 21 st 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 ‘
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
Contact Details + James Merselis CEO Biosensia Limited NovaUCD Belfield Innovation Park UCD Belfield Dublin 4 Ireland James.merselis@biosensia.com www.biosensia.com + 35317163650 16
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