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DEVELOPMENT OF THE PANDX INTEGRATED DIAGNOSTIC PLATFORM
UC BERKELEY
Wallace White, Director, Point-of-Care Diagnostics
March 5, 2015
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
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
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
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
by Global Good
7
by Global Good
8
by Global Good
9
Afar, Ethiopia
by Global Good
10
Afar, Ethiopia
by Global Good
11
12
“Please thank your teachers
for educating you
to be able to do this work.”
13
Overview of the PanDx project
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
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
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
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
Sagie Pillay, CEO of South Africa’s
lab service, with PanDx
19
1: Complete Solutions
20
21
2: Flow
22
Callao, outside Lima, Peru
23
Callao, outside Lima, Peru
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
Patient flow with POC
Day 1
Patient sees clinician
Clinic runs tests
Patient receives diagnosis
26
3: Multiple Perspectives, Multiple Customers
27
South American hospital
28
South American hospital’s NICU
29
4: In Diagnostics We Trust?
30
http://www.passportchop.com/wp-content/uploads/2010/11/Kempinski-Hotel-Security.jpg
31
32
Diagnostics
33
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
5: Life in the Lab
36
37
38
39
Emory’s treatment of the first Ebola patients in the US
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
6: Developed Dx in Developing Settings
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
Health Center Labs in Developing Countries Today
Botshabelo CHC, South Africa
Lab
44
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
PanDx: Multi-technology diagnostics for health centers worldwide
2. Flexible
3. Robust
1. Easy to use
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
PanDx: Multi-technology diagnostics for health centers worldwide
1. Easy to use
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
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
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
Intended Full Menu
Immunoassay
53
Evolution of Concepts
54
55
Handheld
Standalone
Modular Stack
56
57
Console
Advanced Processor
Standard Processor
58
59
60
Current Status
61
Phase 1.5 development progress
CURRENT
62
Current cartridges, by
MTB
HIV p24
ALT
63
Current Breadboard
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
Tools of smallpox eradication
Jet injector Bifurcated needle
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
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
THANK YOU

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

  • 1. DEVELOPMENT OF THE PANDX INTEGRATED DIAGNOSTIC PLATFORM UC BERKELEY Wallace White, Director, Point-of-Care Diagnostics March 5, 2015
  • 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 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 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 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
  • 11. 11
  • 12. 12 “Please thank your teachers for educating you to be able to do this work.”
  • 13. 13 Overview of the PanDx project
  • 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 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 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 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 Sagie Pillay, CEO of South Africa’s lab service, with PanDx
  • 20. 20
  • 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 Patient flow with POC Day 1 Patient sees clinician Clinic runs tests Patient receives diagnosis
  • 26. 26 3: Multiple Perspectives, Multiple Customers
  • 29. 29 4: In Diagnostics We Trust?
  • 31. 31
  • 33. 33
  • 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 5: Life in the Lab
  • 36. 36
  • 37. 37
  • 38. 38
  • 39. 39 Emory’s treatment of the first Ebola patients in the US
  • 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 6: Developed Dx in Developing Settings
  • 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 Health Center Labs in Developing Countries Today Botshabelo CHC, South Africa Lab
  • 44. 44
  • 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 PanDx: Multi-technology diagnostics for health centers worldwide 2. Flexible 3. Robust 1. Easy to use
  • 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 PanDx: Multi-technology diagnostics for health centers worldwide 1. Easy to use
  • 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 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 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
  • 54. 54
  • 56. 56
  • 58. 58
  • 59. 59
  • 61. 61 Phase 1.5 development progress CURRENT
  • 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 Tools of smallpox eradication Jet injector Bifurcated needle
  • 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 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