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March 5, 2015 PoCDx Seminar - Wallace White, Stratos - Development of the PanDx Integrated Diagnostic Platform

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March 5, 2015 PoCDx Seminar - Wallace White, Stratos - Development of the PanDx Integrated Diagnostic Platform

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Development of the PanDx Integrated Diagnostic Platform

Wallace White
Director, Point-of-Care Diagnostics
Stratos Product Development

UC Berkeley, March 5, 2015

After a decade developing point-of-care diagnostics for commercial clients, Stratos Product Development was approached by the Bill and Melinda Gates Foundation for a bigger challenge: creating a single system capable of all the diagnostics needed at primary health clinics in developing countries. In this—the first public talk on the project—Wallace White will describe the development of the PanDx system and share observations from the health-clinic visits on three continents that have informed it.

Video of the talk is available on YouTube: https://www.youtube.com/watch?v=9oewE5NH4mI

Development of the PanDx Integrated Diagnostic Platform

Wallace White
Director, Point-of-Care Diagnostics
Stratos Product Development

UC Berkeley, March 5, 2015

After a decade developing point-of-care diagnostics for commercial clients, Stratos Product Development was approached by the Bill and Melinda Gates Foundation for a bigger challenge: creating a single system capable of all the diagnostics needed at primary health clinics in developing countries. In this—the first public talk on the project—Wallace White will describe the development of the PanDx system and share observations from the health-clinic visits on three continents that have informed it.

Video of the talk is available on YouTube: https://www.youtube.com/watch?v=9oewE5NH4mI

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March 5, 2015 PoCDx Seminar - Wallace White, Stratos - Development of the PanDx Integrated Diagnostic Platform

  1. 1. DEVELOPMENT OF THE PANDX INTEGRATED DIAGNOSTIC PLATFORM UC BERKELEY Wallace White, Director, Point-of-Care Diagnostics March 5, 2015
  2. 2. 2 Stratos is 90 product development professionals in downtown Seattle. The firm was founded in 1987 and creates great products in the Consumer Electronics, Healthcare, Industrial and Enterprise industries. Our client base is widely distributed throughout the United States, Europe and Asia.
  3. 3. 3 Professional Disciplines PRODUCT STRATEGY INDUSTRIAL DESIGN MECHANICAL ENGINEERING ELECTRICAL ENGINEERING PROJECT MANAGEMENT MANUFACTURING STRATEGY SOFTWARE ENGINEERING QUALITY ENGINEERING INTERACTION DESIGN APPLIED RESEARCH Address all stages of product development in-house Veteran design and engineering staff with long-term tenure Cross-discipline, comingled team structure and setting PhD level Optics, Electrical Engineering, and Biochemistry Staff
  4. 4. 4 Life Science Projects Experience Clients Point of Care and In Vitro Diagnostics Critical Care Monitoring and Ventilation Ultrasound Imaging and Therapeutics Drug Delivery and Device Combinations Surgical Tools and Orthopedic Devices Oral and Endoscopic Imaging Catheter Platform Systems Minimally Invasive Devices Global Health Consumer Health
  5. 5. 5 Consumer Electronics Projects Experience Clients Gaming Platforms and Controllers Digital Set-Top Boxes Audio Video Components Projection Systems Personal and Household Electronics Photo Imaging and Printing Desktop and Portable Computing Mobile Handset Devices Personal Computing Peripherals Toys and Entertainment
  6. 6. 6 by Global Good
  7. 7. 7 by Global Good
  8. 8. 8 by Global Good
  9. 9. 9 Afar, Ethiopia by Global Good
  10. 10. 10 Afar, Ethiopia by Global Good
  11. 11. 11
  12. 12. 12 “Please thank your teachers for educating you to be able to do this work.”
  13. 13. 13 Overview of the PanDx project
  14. 14. 14 Point of Care & In Vitro Diagnostics • Liquid and airborne sample collection • Extended storage, stability • Microfluidic control and manifolds • Macro-liquid handling • Magnetic separation • PCR and isothermal control • Fluorescence, Glucometry, Flow Cytometry • Quantitative lateral flow • Voltammetry • Electrochemiluminescence • Surface Plasmon Resonance (SPR)
  15. 15. 15 Can you create a new device that quickly diagnoses HIV, TB, malaria, and other diseases… accepts different samples, like blood, saliva, and sputum… is affordable… and reliable… and will work in a small clinic that has only a few hours of electricity a day? http://www.gatesnotes.com/About-Bill-Gates/Why-Our-Foundation-Takes-On-Grand-Challenges
  16. 16. 16 Today, five public-private partnerships have taken up the challenge. The journey from idea to reality is a long one. For one thing, the partners had to figure out whether making such a machine was even technically feasible. It is—several of them have working prototypes. http://www.gatesnotes.com/About-Bill-Gates/Why-Our-Foundation-Takes-On-Grand-Challenges
  17. 17. 17 http://www.gatesnotes.com/About-Bill-Gates/Why-Our-Foundation-Takes-On-Grand-Challenges This is one of them, the Stratos, which our foundation is developing with a Seattle-based medical engineering company:
  18. 18. 18 Sagie Pillay, CEO of South Africa’s lab service, with PanDx
  19. 19. 19 1: Complete Solutions
  20. 20. 20
  21. 21. 21 2: Flow
  22. 22. 22 Callao, outside Lima, Peru
  23. 23. 23 Callao, outside Lima, Peru
  24. 24. 24 Day 1 Patient sees clinician Day 2 Patient provides sample Day 3 Lab runs test Day 4 (or later) Patient receives diagnosis Patient flow with batch testing
  25. 25. 25 Patient flow with POC Day 1 Patient sees clinician Clinic runs tests Patient receives diagnosis
  26. 26. 26 3: Multiple Perspectives, Multiple Customers
  27. 27. 27 South American hospital
  28. 28. 28 South American hospital’s NICU
  29. 29. 29 4: In Diagnostics We Trust?
  30. 30. 30 http://www.passportchop.com/wp-content/uploads/2010/11/Kempinski-Hotel-Security.jpg
  31. 31. 31
  32. 32. 32 Diagnostics
  33. 33. 33
  34. 34. 34http://journals.plos.org/plosntds/article?id=10.1371/journal.pntd.0002324 33% of the adults’ samples matched none of the tests… How different are things here?
  35. 35. 35 5: Life in the Lab
  36. 36. 36
  37. 37. 37
  38. 38. 38
  39. 39. 39 Emory’s treatment of the first Ebola patients in the US
  40. 40. 40 Emory’s treatment of the first Ebola patients in the US Dedicated POC Lab • No aerosols = no centrifuges • Avoided costly, unwanted transport • Reduced risks of transmission • Immediate results
  41. 41. 41 6: Developed Dx in Developing Settings
  42. 42. 42 Health Center Labs in Developing Countries Today From 2012–2013 Halteres-Stratos market study for BMGF in Ethiopia, Kenya, Brazil, and South Africa
  43. 43. 43 Health Center Labs in Developing Countries Today Botshabelo CHC, South Africa Lab
  44. 44. 44
  45. 45. 45 Product Mission is bringing high-performance, fast tests to Level 1 Health Centers, where patients, clinicians, and therapies are ready for them. • Results ready during a patient visit • Reliable results with minimal training • A broad menu of tests • Nucleic acids • Immunoassays • Clinical chemistry • Gold-standard point-of-care performance Photos from Halteres-Stratos study for BMGF Bottom: early mockup of PanDx
  46. 46. 46 PanDx: Multi-technology diagnostics for health centers worldwide 2. Flexible 3. Robust 1. Easy to use
  47. 47. 47 PanDx: Multi-technology diagnostics for health centers worldwide 1. Easy to use • Fully automatic from sample to answer • Each cartridge contains all of its reagents • No biosafety cabinet needed • No computer experience needed Rendering of PanDx
  48. 48. 48 PanDx: Multi-technology diagnostics for health centers worldwide 1. Easy to use
  49. 49. 49 2. Flexible • Modular for scalability • Random access: any bay can run any test • Up to 90 NATs, 270 IAs, or 540 Clinical Chemistry tests per 15-bay system per day • Wireless connectivity to LIS and the Cloud PanDx: Multi-technology diagnostics for health centers worldwide 1. Easy to use
  50. 50. 50 PanDx: Multi-technology diagnostics for health centers worldwide 2. Flexible 3. Robust • Designed around proven technologies • Integrated 1.5-hour battery backup • Sealed against dust and water • Automation and internal controls give confidence in the results • Operates up to 40 ºC, capable of running assays below ambient • If one bay fails, the others can stay in service 1. Easy to use
  51. 51. 51 M. tuberculosis HIV Viral Load HIV p24 Antigen ALT Assay Type Semi-quantitative Nucleic Acid Quantitative Nucleic Acid Quantitative Immunoassay Quantitative Clinical Chemistry Sample 1–6 mL sputum 1–2 mL whole blood from venipuncture ~100 µL whole blood from heelstick ~40 µL whole blood from fingerstick Target Performance >70% sensitivity on AFB– LOD 50 copies/mL LOD 50 pg/mL 10–1000 U/L, 5% CV, R > 0.95 Target Turnaround Time <60 minutes <60 minutes <20 minutes <10 minutes COGS @ 10M Assuming 40M cartridges across all types $4.19 <$4 target $3.52 <$2 target Development status Demo in progress Paper study complete Demo in progress Demo in progress Example cartridges
  52. 52. 52 Intended Full Menu Immunoassay
  53. 53. 53 Evolution of Concepts
  54. 54. 54
  55. 55. 55 Handheld Standalone Modular Stack
  56. 56. 56
  57. 57. 57 Console Advanced Processor Standard Processor
  58. 58. 58
  59. 59. 59
  60. 60. 60 Current Status
  61. 61. 61 Phase 1.5 development progress CURRENT
  62. 62. 62 Current cartridges, by MTB HIV p24 ALT
  63. 63. 63 Current Breadboard
  64. 64. 64 At the end of current phase, September 2015 Chief deliverables: • Four fully functional breadboards • Performance data from spiked samples on hundreds of each demonstration cartridge (MTB, p24, ALT) • Documentation package of requirements, theory of operations, designs, and testing Feasibility and risk-reduction complete. Ready to execute commercial product development.
  65. 65. 65 Tools of smallpox eradication Jet injector Bifurcated needle
  66. 66. 66 Lessons from William Foege “We learned the need for OPTIMISM. The trouble with being an optimist, of course, is that people think you don’t know what’s going on. But it is the way to live. I tell students there is a place for cynicism and a place for pessimism and whenever you need it, contract for it but don’t get those people on your payroll. They will ruin your day. We were an optimistic group.”
  67. 67. 67 Wallace White Bill Dietze Ian Blanch Megan Kuhn Alan Klug Ryan Frazier Pam Roper Tim Ramsey Stephen Choi Greg Kirkos Jon Lundt Joseph Ullman Mike Nelson Julian Bibl Tom Kadavy Richard Klemm Nadine Hlawatsch Susanne Freyberg Stefan Wollweber Christian Moche Marko Pietraszczyk Holger Becker Claudia Gärtner Rob Taylor Melissa Mugambi Steve Buchsbaum Gene Walther Pete Dailey Rich Thayer Mickey Urdea Laura Penny David Boyle Roger Peck Bernhard Weigl
  68. 68. THANK YOU

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