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Real-Time Mobile Diagnostics & Analytics
Confidential - Patents Pending
Real-Time Diagnostics | Data Transmission | Integration | Analytics
Real-Time Mobile Diagnostics & Analytics
Confidential - 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 testing
Servers
Note: The problem depicted above also applicable for veterinarians, biosurveillance, food security, agriculture, water testing and more.
Real-Time Mobile Diagnostics & Analytics
Confidential - 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
Real-Time Mobile Diagnostics & Analytics
Confidential - Patents Pending
Detecting & Connecting
This mobile phone-sized system provides
and transmits laboratory-quality GPS-tagged
results in 10 minutes or less.
MRSA
Real-Time Mobile Diagnostics & Analytics
Confidential - 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.
Real-Time Mobile Diagnostics & Analytics
Confidential - 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
0.53
mmol/L
Real-Time Mobile Diagnostics & Analytics
Confidential - Patents Pending
Multiplexing
Unlike other diagnostic technologies, ApolloDx’s is designed
to simultaneously detect a range of heterogeneous analytes,
for example proteins and oligonucleotides.
Protein Gene
Real-Time Mobile Diagnostics & Analytics
Confidential - 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
Real-Time Mobile Diagnostics & Analytics
Confidential - Patents Pending
Fast Assay Development Time
Facility
External
Validation*
Internal Validation
HIV U of Nebraska Publication 2 weeks
MRSA U of Ottawa 2-3 days 2 weeks
L-selectin U of Virginia 1.5 weeks first experiment
Theophylline U of Virginia 1 week
*Using ApolloDx reagents
NOTE: Traditional diagnostic assay validation time: 6-12 months!
Real-Time Mobile Diagnostics & Analytics
Confidential - Patents Pending
Thermal Stability
The electrochemical detection system works well in
harsh environmental conditions.
Real-Time Mobile Diagnostics & Analytics
Confidential - 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
Real-Time Mobile Diagnostics & Analytics
Confidential - 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
Real-Time Mobile Diagnostics & Analytics
Confidential - Patents Pending
Geographical Platform Deployment
Platform enables laboratory quality testing in the field and near the patient.
Real-Time Mobile Diagnostics & Analytics
Confidential - 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
Real-Time Mobile Diagnostics & Analytics
Confidential - 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
Real-Time Mobile Diagnostics & Analytics
Confidential - 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
Real-Time Mobile Diagnostics & Analytics
Confidential - 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
Real-Time Mobile Diagnostics & Analytics
Confidential - Patents Pending
The ApolloDx System
Test device ServersTest strip
User Components
ApolloDx Data Repository
and Backend Systems
Smart Device
with ApolloDx app
L
Real-Time Mobile Diagnostics & Analytics
Confidential - 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
3
mmol/L
Transmits data
real-time to the ApolloDx
data repository
Real-Time Mobile Diagnostics & Analytics
Confidential - Patents Pending
Current Prototype Testing Device
ApolloDx Test Device
Real-Time Mobile Diagnostics & Analytics
Confidential - Patents Pending
USB Port
Smart Device
Connection
USB Power
Built in Battery
Sample Port
Inside View of Prototype Test Device
Real-Time Mobile Diagnostics & Analytics
Confidential - 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
Real-Time Mobile Diagnostics & Analytics
Confidential - 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
Real-Time Mobile Diagnostics & Analytics
Confidential - 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
Real-Time Mobile Diagnostics & Analytics
Confidential - 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
Real-Time Mobile Diagnostics & Analytics
Confidential - Patents Pending
Contact Information
ApolloDx, LLC
310 East 300 South
Salt Lake City, UT 84111-2605 USA
+1 801 652 6334
www.apollodx.com
Real-Time Mobile Diagnostics & Analytics
Confidential - Patents Pending

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

  • 1. Real-Time Mobile Diagnostics & Analytics Confidential - Patents Pending Real-Time Diagnostics | Data Transmission | Integration | Analytics
  • 2. Real-Time Mobile Diagnostics & Analytics Confidential - 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 testing Servers Note: The problem depicted above also applicable for veterinarians, biosurveillance, food security, agriculture, water testing and more.
  • 3. Real-Time Mobile Diagnostics & Analytics Confidential - 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
  • 4. Real-Time Mobile Diagnostics & Analytics Confidential - Patents Pending Detecting & Connecting This mobile phone-sized system provides and transmits laboratory-quality GPS-tagged results in 10 minutes or less. MRSA
  • 5. Real-Time Mobile Diagnostics & Analytics Confidential - 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.
  • 6. Real-Time Mobile Diagnostics & Analytics Confidential - 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 0.53 mmol/L
  • 7. Real-Time Mobile Diagnostics & Analytics Confidential - Patents Pending Multiplexing Unlike other diagnostic technologies, ApolloDx’s is designed to simultaneously detect a range of heterogeneous analytes, for example proteins and oligonucleotides. Protein Gene
  • 8. Real-Time Mobile Diagnostics & Analytics Confidential - 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
  • 9. Real-Time Mobile Diagnostics & Analytics Confidential - Patents Pending Fast Assay Development Time Facility External Validation* Internal Validation HIV U of Nebraska Publication 2 weeks MRSA U of Ottawa 2-3 days 2 weeks L-selectin U of Virginia 1.5 weeks first experiment Theophylline U of Virginia 1 week *Using ApolloDx reagents NOTE: Traditional diagnostic assay validation time: 6-12 months!
  • 10. Real-Time Mobile Diagnostics & Analytics Confidential - Patents Pending Thermal Stability The electrochemical detection system works well in harsh environmental conditions.
  • 11. Real-Time Mobile Diagnostics & Analytics Confidential - 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
  • 12. Real-Time Mobile Diagnostics & Analytics Confidential - 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
  • 13. Real-Time Mobile Diagnostics & Analytics Confidential - Patents Pending Geographical Platform Deployment Platform enables laboratory quality testing in the field and near the patient.
  • 14. Real-Time Mobile Diagnostics & Analytics Confidential - 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
  • 15. Real-Time Mobile Diagnostics & Analytics Confidential - 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
  • 16. Real-Time Mobile Diagnostics & Analytics Confidential - 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
  • 17. Real-Time Mobile Diagnostics & Analytics Confidential - 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
  • 18. Real-Time Mobile Diagnostics & Analytics Confidential - Patents Pending The ApolloDx System Test device ServersTest strip User Components ApolloDx Data Repository and Backend Systems Smart Device with ApolloDx app L
  • 19. Real-Time Mobile Diagnostics & Analytics Confidential - 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 3 mmol/L Transmits data real-time to the ApolloDx data repository
  • 20. Real-Time Mobile Diagnostics & Analytics Confidential - Patents Pending Current Prototype Testing Device ApolloDx Test Device
  • 21. Real-Time Mobile Diagnostics & Analytics Confidential - Patents Pending USB Port Smart Device Connection USB Power Built in Battery Sample Port Inside View of Prototype Test Device
  • 22. Real-Time Mobile Diagnostics & Analytics Confidential - 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
  • 23. Real-Time Mobile Diagnostics & Analytics Confidential - 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
  • 24. Real-Time Mobile Diagnostics & Analytics Confidential - 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
  • 25. Real-Time Mobile Diagnostics & Analytics Confidential - 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
  • 26. Real-Time Mobile Diagnostics & Analytics Confidential - Patents Pending Contact Information ApolloDx, LLC 310 East 300 South Salt Lake City, UT 84111-2605 USA +1 801 652 6334 www.apollodx.com
  • 27. Real-Time Mobile Diagnostics & Analytics Confidential - Patents Pending