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

6 by Global Good

7 by Global Good

8 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

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:

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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 http://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

THANK YOU