Rapid Detection of Infectious Agents using SiNW Technologies.

Transcription

1 Rapid Detection of Infectious Agents using SiNW Technologies. Presentation to ABIC 2010, Saskatoon, Canada. September 14th, Dr. Graeme K. Frith, Exocyte Limited.

2 Introduction History Strategy Technology Further Development Case Study: Detect IT Current Projects Statement of Work Data

3 Disclaimer This presentation contains certain statements that are not historical facts and may be forward-looking statements that are subject to a variety of risks and uncertainties. There are a number of important factors that could cause actual results to differ materially from those projected or suggested in any forwardlooking statement made by Exocyte Ltd ( the Company ). These factors include, but are not limited to: (i) the Company's and/or the Company's partners ability to successfully complete product development and commercialization; (ii) the Company's and/or the Company's partners ability to obtain required governmental approvals, including product and patent approvals, the impact of industry regulations, the difficulty of predicting regulatory authority approvals, the regulatory environment and changes in policies of various countries; (iii) the acceptance and demand for new detection technologies and products and the Company's ability to attract and/or maintain manufacturing, sales, distribution and marketing partners; and (iv) the Company's and/or the Company's partners ability to develop and commercialise services and products before its competitors and the impact of competitive products and pricing, the availability and pricing of components used in the manufacture of products, uncertainties regarding market acceptance of innovative products newly launched, currently being sold or in development. In addition, significant fluctuations in financial results may occur as a result of the timing of customer payments and the timing of costs and expenses related to the Company's research and development program. Without limiting the generality of the foregoing, no assurance is given as to when the Company s products will be launched or whether that launch will be commercially successful, and words such as "may," "will," "to," "expect," "plan," "believe," "anticipate," "intend," "could," "would," "estimate," or "continue" or the negative or other variations thereof or comparable terminology is intended to identify forwardlooking statements. Investors are cautioned that all forward-looking statements involve risks and uncertainties. The Company, its subsidiaries, Directors, Officers, Associates or Advisors shall under no circumstance be liable to investor or any other third party for any lost profits or lost opportunity, indirect, incidental, consequential, special, or punitive damages whatsoever.

4 Exocyte History Exocyte Reading, UK. EJIVR spin-out, 2005 Patent estate, know-how & in-licensing Subject Matter Expert consultancy services Government Partnering US DOD, DHS & State Department. BTRP US DOD CRADA s, SBIR grant proposals. Next generation diagnostics & detection platforms Commercial Partnering System Integrator & University projects Strategic alliances, grants & fee for service Multiple commercial relationships Funding Privately-owned & self-funded Model 1.0. working prototype Model 2.0. hand-held embedded device

5 Exocyte Strategy Our Vision to lead the development of cost-effective the development of integrated detection and diagnostic platforms in detection & diagnostic specific high-value sectors. in sectors. Areas of Interest Bio-threat & emerging pathogen detection & Emerging Pathogen Detection Host responses: infection, injury & intervention & Pathogen Biomarker Responses Environmental contamination: fuel & water Contamination Market Targets Point of need integrated detection & reporting Point-of-need detection & reporting Government agencies In-line detection platforms High value commercial markets markets Performance Advantages Sensitivity, specificity, speed, reproducibility, specificity, speed, label-free, targets, multiplexing, no amplification, device & no amplification, integration, TRL/ MRL 4-5, communications integration, TRL4-6, cost. manufacturing & supply chain, cost.

6 Technology USP s Multiple Analytes Bacteria, Viruses, Fungi, Toxins Proteins, Nucleic Acids, Carbohydrates Sensitivity & Specificity 2-5 fmol Antigen 2 mins fmol Nucleic Acid 5-30 mins Multiplexing capability SiNW s/chip Quantitative & context-rich data Device Integration Small, Portable & Low Power. Retro-fit, PoC, PoN, Stand-off CMOS Compatible Secure manufacturing & supply chain QA, QC, low cost, high volume

7 Technology Description What is Happening? Direct detection of single molecule binding events. Detecting changes in electrical resistance (FET) Sensitivity & Specificity SiNW detection surface. High surface area/ volume Individually addressable. Detecting ligand quality. Reproducibility Amplification Label-free. Amplification-independent. Signal α target copy number. Miniaturisation & Portability Chip + Detector + Reporter. Point of Care & Need; retro-fit integration Integrated Reporting Real time data processing Real time reporting formats 3G, Internet, RFID

8 SiNW Chip Design (a) Contact metal pads 300uM x 300uM 500uM/pad (c) 5 SiNW/cluster 100uM long, 30-50nm wide (b) 40 SiNW clusters 200uM/cluster 2uM/SiNW (d) 200 SiNW/chip. Each independently addressable sensor

9 Surface Chemistry Common Platform Nucleic Acid Hybridization Antigen Capture Target Detection Ligand NH C = O NH C = O Coupling Chemistry C = O NH NH NH NH Si Si SiNW Si O O Si O Si O Si O Si O Si Activation

10 Real time Multiplexing Nature Reviews Cancer, 5 (2005) 161. Detecting ligand (e.g. mab, oligo, MIP ) covalently attached to SiNW Selective binding causes a change in resistance of SiNW This causes a change in charge density DEBYEV Field Effect Field effect is measured, transmitted, displayed in a device

11 Model 2.0 Development Model 1.0 Model 2.0 Envisaged products Embedded Device design Current design Chip manufacture Hand-held Surface Chemistry In-line

12 Case Study Russia Disease Surveillance Projects Enhancing disease surveillance in North Caucus. Animal Diseases: FMD, ASF, CSF. Zoonotic Diseases: Threat Agents. Current situation Central & regional reference laboratories Multiple labs, assay formats, variable results Poor coordination with sanitary control system PACS, EIDSS & TADR Access to key individuals, sites, reagents & technologies Identify capability gaps & future needs Improve Detect-to-Treat/ Detect-to-Decontaminate Act Local Field-deployable detection & reporting system High-value data: multiplexing, sensitivity, specificity Transmit data in real time, quickly coordinate response.

13 Risks to North America FMDV UK 2001 Pan Asia O: a stable genome in a global economy 2000 cases, 7-10 M culled, 85% $16B/ 8B, impact on rural economy & GDP. ASF RF North Caucus, backyard farms & wild boars Stamping out policy- no vaccine or diagnostics Virus stable in animal & meat products North America Agriculture 17% GDP, 13% employment Extensive trade across Canada, US & Mexico Trans-border disease surveillance. Product value. Trans-Border Need Field-deployable detection & reporting system High-value data: multiplexing, sensitivity, specificity Transmit relevant data in real time.

14 Case Study Detect IT Sample Collection & Preparation SiNW Detection Model 1.0 Secure Global Reporting

15 Case Study Detect IT Project Requirement Active Disease Surveillance Platform Real time multiplexed detection Field-deployable, sensitive & specific Prototype Joint development project Integrated detection & reporting elements Mobile secure HL7 data transmission. Results Biotin Avidin detection 2-5fmol Data collection, processing & 2 minutes Demonstration TRL 4-5 Next steps Raising finance Model 2.0 embedded sensor Investigating new markets & partners

16 Current Projects Area Bio-Threat Surveillance Potential Role Real-time detection, identification & reporting Mass screening & response to intervention Fuels Improve fuel supply, storage and efficiency Reduce servicing, repair & replacement costs Ballast Water Detection & decontamination of microbes Port entry, reduce servicing & repair costs Food Safety Detection of pathogens, toxins, antibiotics & GM Assess exclusion & decontamination methods BioPharma Vaccine, biologics & small drug discovery Assay consolidation, QA & QC testing

17 Statement of Work Proposed Work Agent Milestone & Outcome Recovery and characterisation of target Virus, bacteria, fungi, biomarker, protein, DNA. Ligand Generate, screen & select high-affinity ligands mabs, Fabs, scfv s, oligo s, MIPS Prototype Generate SiNW chip & lab test against target. Sample processing, dose-response curves Test Field test optimal SiNW chip design Investigate device integration Deploy Provide customer with functionalised chips Agreed volume & price.

18 Model Protein Project

19 Toxin Project

20 Serum Bio-Markers Chua et al, Anal. Chem. 2009, 81,

21 DNA-PNA Hybridisation Project Guo et al, Anal. Chem. 2007, 79,

22 SNiP Project

23 Questions? Dr. Graeme K. Frith, Exocyte Ltd. +44(0) Thank you!