The document discusses the development of the PanDx integrated diagnostic platform by UC Berkeley. It provides an overview of the project, which aims to create a portable diagnostic device that can quickly diagnose diseases like HIV, TB, and malaria using different sample types in resource-limited settings. The device is being designed to be affordable, reliable, and able to function in areas with limited electricity. Updates are provided on the development progress, including demonstration cartridges being tested for tuberculosis, HIV p24 antigen, and ALT clinical chemistry assays. The goal is to have fully functional breadboard prototypes and performance data from hundreds of demonstration cartridge tests in multiple assays by the end of the current development phase in September 2015.

1. DEVELOPMENT OF THE PANDX INTEGRATED DIAGNOSTIC PLATFORM
UC BERKELEY
Wallace White, Director, Point-of-Care Diagnostics
March 5, 2015

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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.

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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

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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

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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

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by Global Good

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by Global Good

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by Global Good

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Afar, Ethiopia
by Global Good

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Afar, Ethiopia
by Global Good

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“Please thank your teachers
for educating you
to be able to do this work.”

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Overview of the PanDx project

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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)

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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

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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

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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:

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Sagie Pillay, CEO of South Africa’s
lab service, with PanDx

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1: Complete Solutions

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2: Flow

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Callao, outside Lima, Peru

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Callao, outside Lima, Peru

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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

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Patient flow with POC
Day 1
Patient sees clinician
Clinic runs tests
Patient receives diagnosis

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3: Multiple Perspectives, Multiple Customers

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South American hospital

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South American hospital’s NICU

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4: In Diagnostics We Trust?

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http://www.passportchop.com/wp-content/uploads/2010/11/Kempinski-Hotel-Security.jpg

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Diagnostics

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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?

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5: Life in the Lab

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Emory’s treatment of the first Ebola patients in the US

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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

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6: Developed Dx in Developing Settings

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Health Center Labs in Developing Countries Today
From 2012–2013 Halteres-Stratos market study for BMGF
in Ethiopia, Kenya, Brazil, and South Africa

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Health Center Labs in Developing Countries Today
Botshabelo CHC, South Africa
Lab

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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

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PanDx: Multi-technology diagnostics for health centers worldwide
2. Flexible
3. Robust
1. Easy to use

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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

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PanDx: Multi-technology diagnostics for health centers worldwide
1. Easy to use

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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

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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

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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

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Intended Full Menu
Immunoassay

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Evolution of Concepts

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Handheld
Standalone
Modular Stack

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Console
Advanced Processor
Standard Processor

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Current Status

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Phase 1.5 development progress
CURRENT

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Current cartridges, by
MTB
HIV p24
ALT

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Current Breadboard

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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.

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Tools of smallpox eradication
Jet injector Bifurcated needle

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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.”

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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. THANK YOU