Download Wall Street Analyst Forum`s - Corporate-ir

The Wall Street Analyst Forum’s 17th
Annual Analyst Conference
Forward Looking
Statements…
During this presentation, our remarks will include
forward-looking statements. These statements are
neither promises nor guarantees, but involve risks and
uncertainties that could cause actual results to differ
materially from those anticipated or indicated. Any
forward-looking statements should be considered in light
of such risks and uncertainties including, without
limitation, those detailed in the Company's filings with
the SEC, including those discussed in the prospectus
supplement.
Our Current Mission
“To eradicate mortality from
colorectal cancer through
early detection using applied
genomics”
The Promise of EXAS
• Large unmet medical market
• No controversy- early detection provides less
costly treatment & saves lives
• Pre-Gen-Plus is first “average risk” marketed
genomics diagnostic for CRC
• Molecular biology & mutations associated
with CRC are well known
• Ability to detect these mutations in stool,
which provides us with a biological advantage
• PreGen-Plus is the most accurate noninvasive diagnostic available
Five-year
Survival Rate for CRC
Two-thirds of Patients
are Diagnosed Too Late
100
75
95%
100
80%
75
50
50
25
25
0
Dukes A Dukes B
Early Diagnosis
37% of Patients
0
55%
10%
Dukes C Dukes D
Late Diagnosis
63% of Patients
A Success and a Failure
Colorectal vs. Cervical Cancer Death
Estimates
Screening Colo
60,000
FOBT
Colo
Flex Sig
50,000
Pap
40,000
10,000
0
1950
1960
Cervical
1970
1980
Colorectal
Source: World Health Organization, American Cancer Society
1990
2000
The Opportunity in CRC
People Over the Age of 50
Should Be Screened Regularly
2002
2003
2004
2005
100
80
People
Over 50
60
(Millions)
40
20
0
80% Unscreened
20% Screened
Increases by 4 Million Each Year
A New Genetic Model
Validation of PreGen
Plus
• PreGen-Plus is a single test comprised of 23 molecular
markers of CRC
• PreGen-Plus has significant clinical publications
–
–
–
–
Gastroenterology (2000,04, and 04)
Clinical Colorectal Cancer (2003)
New England Journal of Medicine (2004)
Journal of Molecular Diagnostics 2004
• Blue Shield California Technology Assessment
• Patients are more compliant
–
–
–
–
Single whole stool specimen
No bowel preparation
No medication or dietary restrictions
No sample manipulation
Clinical Utility
= f (A x C x D)
Accuracy
FOBT
Flex Sig
Colonoscopy
PreGen-Plus™
Compliance
Distribution /
Access
Our Short Term Strategy
 Develop Cancer Specific Non-Invasive Assay
 Demonstrate Superiority to Already Recommended
Screening Modality in Average Risk Population (MCS)
 Introduce Commercial Assay-PreGen-Plus™ through
LabCorp
• Product Adoption/Guideline Inclusion/Payor Policy
Observations &
Confirmations
The Importance of
Guideline Inclusion
Multi-Society Task Force/ACS
• 13 State Mandates
• NCQA/HEDIS Guidelines
• Requirement for self insured
• Positive impact on payors
• Will tip the scales for some doctors
How to get into
Guidelines
Requirements
• Peer reviewed studies to prove
equality/superiority
• Acceptability to patients
• Comparable or lower complication rates & costs
• Feasibility in general clinical practice
• Thought leader support
• Demand
American Cancer Society
2015 Challenge Goals
General
• 50% reduction in age-adjusted
cancer mortality rates
• 25% reduction in age-adjusted
cancer incidences rates
Reduce
Cancer
Colorectal Cancer
• Increase to 75% the proportion of people
over the age of 50 years who have CRC
screening consistent with ACS guidelines
– e.g., FOBT, flex sig, DCBE, colonoscopy
Increase
Screening
Payors
Managed Care / Self-Insured Employers
• Clinical Studies
• Thought Leaders
• Provider Pressure
• Membership Demand
• Cost Effectiveness
• NCQA/HEDIS Guidelines
EXAS Value Drivers
• Guideline Inclusion
• Payor Policy Decisions
• Strong Development Strategy
– Improved Assay for CRC
– Assay for Pre-Cancer
Applied Research
Development Strategy
• Stage I
√ Develop Cancer Specific Assay
√ Demonstrate Superiority to Already Recommended Screening
Modality in Average Risk Population (MCS)
√ Introduce Commercial Assay through partner
– Guideline Inclusion
• Stage II
– Increase Performance
• Cancer
• Adenomas
– Decrease Cost
• Stage III
– Apply Assay to Platform
• Kit Development
Assay Improvements
(Stage II)
• Increase DNA Yield
– Effipure DNA Prep.
• Sample Handling
– Stabilize Sample During Collection Method
• Marker Reformulation
–
–
–
–
De Novo Mutation Scanning (e.g. APC MCR)
Hypermethylation
Cancer Detection
Pre-Cancer Detection
Next Generation
Assay performance
Tumor tissue analysis
V1 assay
Cancer tissues analyzed
Assay positive samples
(95% CI)
94
68
Adenoma tissues analyzed
Assay positive samples
(95% CI)
50
31
72.3%
(62.2-81.1%)
62.0%
(47.2-75.4%)
V2 assay
94
88
50
46
93.6%
(86.6-97.6%)
92.0%
(80.8-97.8%)
The Future
More Depth in
Colorectal Cancer
Other Screening
Opportunities
Expanding
Internationally
The Wall Street Analyst Forum’s 17th Annual
Analyst Conference