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Real-Time Diagnostics | Data Transmission | Integration | Analytics

ApolloDx's mDx Platform - Real-Time Results Transmitted Instantly

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ApolloDx is developing a Mobile Diagnostic Platform comprised of a smart device attached to an analyzer. This system provides and transmits laboratory-quality, GPS-tagged results in 10 minutes or less. It is capable of multiplexing a broad range of analytes from ions to cells and discerning viable versus non-viable pathogens. The bidirectional data transmission with real-time analytics enables medical professionals to practice evidence-based medicine.

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Page 1: ApolloDx's mDx Platform - Real-Time Results Transmitted Instantly

Real-Time Mobile Diagnostics & AnalyticsConfidential - Patents Pending

Real-Time Diagnostics | Data Transmission | Integration | Analytics

Page 2: ApolloDx's mDx Platform - Real-Time Results Transmitted Instantly

Real-Time Mobile Diagnostics & AnalyticsConfidential - Patents Pending

Current IVD Testing versus True POCT & Real-Time Analytics

Label specimen

Sort

Obtain/review results

Collect specimen

Hours to days

for results

Problem

Process samples

Perform pre-analytical

procedures

Real-time results at a lower cost +

Solution

Bidirectional data transmission

provides real-time analytics enabling

medical professionals to make high-

quality decisions and to practice

evidence-based medicine.

Receive results

hours to days later

Send to laboratory

+

True point-of-care,

real-time testingServers

Note: The problem depicted above also applicable for veterinarians, biosurveillance, food security, agriculture, water testing and more.

Page 3: ApolloDx's mDx Platform - Real-Time Results Transmitted Instantly

Real-Time Mobile Diagnostics & AnalyticsConfidential - Patents Pending

System Description

• World’s First: Mobile diagnostic platform that

detects and wirelessly transmits GPS-tagged results

to the ApolloDx data repository

• Lightweight, handheld and battery-operated

system controlled by smart device that

provides the user interface

• Overcomes the turnaround time problem

Page 4: ApolloDx's mDx Platform - Real-Time Results Transmitted Instantly

Real-Time Mobile Diagnostics & AnalyticsConfidential - Patents Pending

Detecting & Connecting

This mobile phone-sized system provides

and transmits laboratory-quality GPS-tagged

results in 10 minutes or less.

MRSA

Page 5: ApolloDx's mDx Platform - Real-Time Results Transmitted Instantly

Real-Time Mobile Diagnostics & AnalyticsConfidential - Patents Pending

Ease-of-Use

The intuitive software enables use by

medical professionals, technicians, first

responders and civilian population. This

platform is designed to qualify for CLIA

waiver.

Page 6: ApolloDx's mDx Platform - Real-Time Results Transmitted Instantly

Real-Time Mobile Diagnostics & AnalyticsConfidential - Patents Pending

Broad Range of Analytes

This test system uses an electrochemical

detection method that detects a broad range of

analytes as shown below. Test results are

qualitative and/or quantitative, depending on

requirements.LITHIUM

0.53mmol/L

Page 8: ApolloDx's mDx Platform - Real-Time Results Transmitted Instantly

Real-Time Mobile Diagnostics & AnalyticsConfidential - Patents Pending

Viable versus Non-Viable Pathogen Detection

ApolloDx’s system: designed to distinguish between viable and non-viable

pathogens.

• Culture takes from 1 to 30 days depending on the species, which is problematic in the

context of life-threatening infections.

• Polymerase chain reaction (PCR) cannot distinguish viable bacterial cells from non-

viable cells.

Viable Pathogen Non-Viable Pathogen

Viable but nonculturable (VBNC) http://en.wikipedia.org/wiki/Viable_but_nonculturable

Page 10: ApolloDx's mDx Platform - Real-Time Results Transmitted Instantly

Real-Time Mobile Diagnostics & AnalyticsConfidential - Patents Pending

Thermal Stability

The electrochemical detection system works well in

harsh environmental conditions.

Page 11: ApolloDx's mDx Platform - Real-Time Results Transmitted Instantly

Real-Time Mobile Diagnostics & AnalyticsConfidential - Patents Pending

Long Shelf Life

Chemistry used in the test strips and cartridges is designed to

have a shelf life of 5 to 10 years in thermally challenging

environments.

Test strip Test cartridge

Page 12: ApolloDx's mDx Platform - Real-Time Results Transmitted Instantly

Real-Time Mobile Diagnostics & AnalyticsConfidential - Patents Pending

Low Cost, Laboratory Quality Results

Smart device, analyzer and test device are

reusable equipment intended for years of service.

Analyzer cost ~ cost of a smart device.

Test strips and cartridges are single-use

consumables competitive with current market

pricing.

Test strip Test cartridge

Analyzer

Smart Device with

ApolloDx app

Page 13: ApolloDx's mDx Platform - Real-Time Results Transmitted Instantly

Real-Time Mobile Diagnostics & AnalyticsConfidential - Patents Pending

Geographical Platform Deployment

Platform enables laboratory quality testing in the field and near the patient.

Page 14: ApolloDx's mDx Platform - Real-Time Results Transmitted Instantly

Real-Time Mobile Diagnostics & AnalyticsConfidential - Patents Pending

Transmits Real-Time Results

Results can be aggregated into a heat map for real-time and trending purposes.

Test Location Result Value Date Latitude Longitude

Theophylline Salt Lake City Negative < 1 mcg/mL 7/9/14 12:14 PM 40.75132456 111.88332136

Theophylline Dallas Positive 5 mcg/mL 7/9/14 11:48 AM 32.77580000 96.79670000

Theophylline Dallas Positive 12.5 mcg/mL 7/9/14 11:44 AM 32.77578766 96.79668149

Page 15: ApolloDx's mDx Platform - Real-Time Results Transmitted Instantly

Real-Time Mobile Diagnostics & AnalyticsConfidential - Patents Pending

Data Integration

The ApolloDx API provides

HIPAA compliant methods for

integrating with existing systems.

LIS Integration

EHR Integration

Heat Mapping

Health Services

Real-Time Analytics

Real-Time Trends

ApolloDx API

Only wireless system: ApolloDx

Page 16: ApolloDx's mDx Platform - Real-Time Results Transmitted Instantly

Real-Time Mobile Diagnostics & AnalyticsConfidential - Patents Pending

Data Analytics

Bidirectional data

transmission provides real-

time analytics enabling

medical professionals to

make high-quality decisions

and to practice evidence-

based medicine.

Healthcare provider

ApolloDx Data Repository

and Backend SystemsSmart device with

ApolloDx’s app

Page 17: ApolloDx's mDx Platform - Real-Time Results Transmitted Instantly

Real-Time Mobile Diagnostics & AnalyticsConfidential - Patents Pending

Intellectual Property

Multiple Patents Pending• Diagnostic consumable design and interface with smartdevice

• Smartphone used for controlling medical devices (with

exceptions)

• Downloadable application controlling a diagnostic test

• Electro- and/or pressure-activation forces used to move fluids

within diagnostic consumable controlled by a MCD*

• Electron-generating signals used on a consumable to

quantitate results of a diagnostic test controlled by a MCD

• Analyte-specific, comprehensive support network used to

geocentrically surround the user.

*MCD: Mobile Computing Device

Page 18: ApolloDx's mDx Platform - Real-Time Results Transmitted Instantly

Real-Time Mobile Diagnostics & AnalyticsConfidential - Patents Pending

The ApolloDx System

Test device ServersTest strip

User ComponentsApolloDx Data Repository

and Backend Systems

Smart Device

with ApolloDx app

L

Page 19: ApolloDx's mDx Platform - Real-Time Results Transmitted Instantly

Real-Time Mobile Diagnostics & AnalyticsConfidential - Patents Pending

How It Works

Scan IDs of provider

and patient

Collect sample,

apply to test strip

Insert test strip

into test device

Qualitative and/or

quantitative results

in ≤10 minutes

LITHIU

M

0.5

3mmol/L

Transmits data

real-time to the ApolloDx

data repository

Page 20: ApolloDx's mDx Platform - Real-Time Results Transmitted Instantly

Real-Time Mobile Diagnostics & AnalyticsConfidential - Patents Pending

Current Prototype Testing Device

ApolloDx Test Device

Page 21: ApolloDx's mDx Platform - Real-Time Results Transmitted Instantly

Real-Time Mobile Diagnostics & AnalyticsConfidential - Patents Pending

USB Port

Smart Device

Connection

USB Power

Built in Battery

Sample Port

Inside View of Prototype Test Device

Page 22: ApolloDx's mDx Platform - Real-Time Results Transmitted Instantly

Real-Time Mobile Diagnostics & AnalyticsConfidential - Patents Pending

“Within any industry, as technology

becomes more decentralized, it manifests

in the form of more efficient, lower cost

and more personalized products or

services.”

Clayton Christiansen

Professor of Business Administration

Harvard University

Decentralizing Testing

Page 23: ApolloDx's mDx Platform - Real-Time Results Transmitted Instantly

Real-Time Mobile Diagnostics & AnalyticsConfidential - Patents Pending

“With point-of-care testing, I

think we’ll be amazed by what

happens in five years. And

we’ll be stupefied at what

we’ll be able to do in 10

years.”

Point of Care Testing

Timothy R. Hamill, MD

Vice Chair, CAP POCT Committee

Director of Clinical Laboratories

Univ. of California / San Francisco

CAP Today - May 2014

Page 24: ApolloDx's mDx Platform - Real-Time Results Transmitted Instantly

Real-Time Mobile Diagnostics & AnalyticsConfidential - Patents Pending

ApolloDx’s Mobile Diagnostic Platform: System Features

• Ease-of-use

• Broad range of analytes

• Multiplexing

• Thermal stability

• Long shelf life

• Low cost for laboratory-quality results

• In field and near patient use capability

World’s first mobile diagnostic platform detects and

wirelessly transmits GPS-tagged results:

• Connectivity to L.I.S.

• Globally accessible data repository

• Data integration and analytics

• Fast assay development time

• Strong intellectual property

position

Page 25: ApolloDx's mDx Platform - Real-Time Results Transmitted Instantly

Real-Time Mobile Diagnostics & AnalyticsConfidential - Patents Pending

ApolloDx’s Mobile Diagnostic Platform: Impact on Diagnostics

Decentralizing laboratory testing with real-time laboratory-

quality results plus data consolidation, integration and

analytics capability:

• Speeds diagnosis

• Improves outcomes

• Lowers costs

• Increases satisfaction

Page 27: ApolloDx's mDx Platform - Real-Time Results Transmitted Instantly

Real-Time Mobile Diagnostics & AnalyticsConfidential - Patents Pending