













|
FDA-Cleared
Test |
# Bio-
Markers |
Application
|
Sensitivity
|
Specificity
|
NPV
|
|
CA 125 1
|
1
|
Tumor
Marker (primarily Ovarian) |
77
|
68
|
87
|
|
Fujirebio -
ROMA 2 |
2
|
Ovarian
Cancer |
88
|
67
|
96
|
|
Vermillion -
Ova 11 |
5
|
Ovarian
Cancer |
94
|
35
|
93
|

|
Pilot Study
Metrics & Milestones*
|
|
|
Number of Sites
|
11
|
|
Patients Enrolled
|
406
|
|
Prevalence of Appendicitis
|
28%
|
|
% of Patients who Underwent CT
|
37%
|
|
Samples Tested for Multi-Markers
|
197
|
|
Enrollment Completion (~500 Patients)
|
Nov 11
|
|
Follow-up FDA Meeting Request
|
Q4/11
|

|
|
MRP 8/14
|
Multi-Marker
|
||
|
|
Results
|
95% CI
|
Results*
|
95% CI
|
|
Sensitivity
|
90%
|
74 - 96
|
95%
|
87 - 99
|
|
Specificity
|
33%
|
25 - 42
|
40%
|
35 - 52
|
|
NPV
|
93%
|
81 - 98
|
97%
|
93 - 99
|

|
D-Dimer and AppyScore
|
||
|
Share Similar Regulatory Pathways
|
||
|
|
|
|
|
|
D-Dimer
|
AppyScore
|
|
Condition Being Evaluated
|
Pulmonary
Embolism |
Appendicitis
|
|
Rule-Out Test to Aid in Patient
Management (Low Disease Risk) |
Yes
|
Yes
|
|
Probability of the Disease
|
Low
|
Low
|
|
Use of Pretest Probability
|
Yes
|
Yes
|
|
Negative Predictive Value
|
High
|
High
|
|
Specificity
|
Moderate
|
Moderate
|
|
Competition
|
Significant
|
None
|
|
Number of Test Manufacturers
|
14
|
One
|



|
Summary Capitalization
|
|
|
Market Cap. (10/20/11)
|
$18.7M
|
|
Shares Outstanding*
|
8.0M
|
|
Public Float, est.
|
7.8M
|
|
|
|
|
Ownership Summary
|
|
|
Institutional Holdings, est.
|
26.4%
|
|
Insider Holdings, est.
|
3.0%
|
|
Summary Balance Sheet
|
|
|
Cash & Equiv. (9/30/11)
|
$4.8M
|
|
Total Assets (mrq)
|
$12.0M
|
|
Total Liabilities (mrq)
|
$5.7M
|
