Transcript Document
Presenter
Anna Daily Ph.D.-Senior Scientist
March 9, 2012
Breast Health Providers Conference
Why A New Approach to Breast
Cancer Screening?
Of women age 40 and over with insurance
coverage only 50% participate in yearly
screenings.
Why women don’t participate:
Dense Breast Tissue
Lack of Facility Access
Some find procedure painful
Cost prohibitive for uninsured
False Positive rate of 5% per exam= 50% over
per patient lifetime
Ascendant Diagnostics is
Developing:
A Low Cost
Non-Invasive
Screening Method for Breast Cancer
Detects proteins present in tear samples
Based on technology licensed from UAMS
An inexpensive, highly accurate test that can diagnose
cancer at earlier stages is highly sought after
Why Tears?
Easy and Quick to Collect
Pain Free
Non-invasive
Contain Protein in High Concentrations
Easy to Prep for Test
SELDI TOF MS
Figure 3: Tears will be collected
Figure
4: Tears
will be
Collect
Tear
Sample
using a tuberculine
syringe
with
collected
using
a
tuberculine
the needle removed
syringe with the needle
removed
Analyze Tears by
Mass Spectrometry
Figure**: Raw SELDI data indicating possible biomarkers at m/z 4038.
Look for Differences
Mass Spectrometry
x104
4045.798
2.5
2.0
1.5
1.0
14691.861
0.5
16421.046
3122.430
17439.815
13899.559
8211.195
11719.514
0.0
2000
4000
6000
8000
10000
12000
14000
16000
Private Industry
Quest
LabCorp
PeaceHealth Labs
18000
20000
m/z
Intensity
Bigger peak=more protein
Intens. [a.u.]
Separates samples based on Size
Increasing size
Drug Testing
Monitoring Pain Medication
Monitor metabolic disorders
Genomics vs. Proteomics
DNA Sequences
Predictive of Risk
Not Diagnostic
Protein Structure and
Function
Diagnostic
Imaging is the Gold Standard
Technique
Ionizing
Radiation
Breast
Compression
False
Negative
Rate
False
Positive
Rate
Mammography
Yes
YES
10-30%
Up to 75%
Ultrasound
No
No
>30%
Up to 65%
PET
Yes
No
15-25%
25 to 75%
MRI
No
No
1-15%
25 to 75%
Tear Testing
80% Sensitive
75% Specific
90% Sensitive
90% Specific
$75.00 per test vs. $200 for mammogram
Regulatory Pathway
CLIA: Clinical Laboratory Improvements Amendment
Physicians Clinics
and Hospitals
supplied with
prepackaged
mailers
Collect Tear
samples from
patients
Results
returned to
Physician
Tear samples go
directly to
partnered
medical testing
facility
Ascendant
Diagnostics
team member
carries out
analysis
Figure 5: Pathway from collection of samples to results.
Carry out
Mass
Spectrometry
Return results
to Ascendant
Diagnostics
Timeline
Licensed
Technology;
Business
Case;
Established
Strategic
Partnerships
Protein
Biomarker
Identification;
2 cohorts of
300 patients;
establish
more
partnerships;
develop CLIA
protocol
2011
2012
Clinical
Validation;
Marketing
and Sales
Team Build
up
Contract
Development
of POC Lab
on a Chip
and Contract
Development
of Reagents;
Sales and
Mktg.
Other
Cancer
biomarkers;
lines
between
treatment
and level of
protein
2013
2014
2015
Collaborations
• University of Arkansas Statewide Mass Spectrometry Facility
–
–
–
–
established February 2011
Acess to mass spectrometry instrumentation
Collabroations on Grant applications
Aid in development of CLIA based protocol
• The Breast Center
– established February 2012
– 300 tear samples over the next 2 years
• Peace Health Labs
– Established August 2011
– Aid and in development and testing of CLIA lab protocol
• Winthrop P. Rockefeller Cancer Institute Women’s clinic
(UAMS)
– In Progress
– 300 tear samples over the next 2 years
Management Team
Scientific Advisory Board
Contact Information
Omid Moghadam
CEO
479-571-2592 [email protected]
Anna Daily Ph.D.
Scientist
479-571-2592
Benefits of
Tear-Based
Screening
High
Specificity
Pain Free
Non
Invasive
[email protected]
Lower
Cost
Increase
Early
Detection
Rapid
Results