Transcript Document

MarkPap® TECHNOLOGY
Focal Points
BioSciCon, Inc.
7/18/2015
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Focal Points
 Technology
Overview
 Company Overview
 MarkPap® Products
 Pap Test Market
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BioSciCon’s
MarkPap® Technology
BioSciCon sponsors the development of MarkPap®
Technology Products to enhance the visibility and
detection of abnormal cells on Pap smears and
monolayers of cervical specimens by introducing a
new, proprietary biomarker of cellular abnormality.
:
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PAPANICOLAOU STAINING OF A CONVENTIONAL PAP
SMEAR AND A THINPREP PAP TEST THIN-LAYER
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Why Enhancing Pap Test?

50 M Pap tests per year in the U.S

15% false negatives

The use of biomarker may reduce false negative readings over
50%

13,000 new cervical cancers per year in the US

If MarkPap® Test were available, these numbers would have
been different: 12,000 new cases, 7% false negatives
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MarkPap® Test
BIOMARKER
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MarkPap® Test
BIOMARKER
BIOMARKER
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MarkPap® Product Family
MarkPap® Test
Phase 2/3 Clinical Trial
Service available for research
purposes only
MarkPap® Research Kit
Beta-testing
Commercially available for
research purposes only
MarkPap® Solution
Commercially available for
research purposes only
MarkPap® Processor
Under development
MarkPap® Workstation
Under development
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BioSciCon’s Mission Statement
Our primary mission is to bring the
MarkPap® test to the public as soon as
possible and save women lives.
The MarkPap® family of products will be
manufactured and sold through
partnerships with established medical
device providers.
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Company Information
Biomedical Science Consulting Company ,
BioSciCon, Inc. is a woman-owned small business with
BioSciCon Center located in Rockville, MD with two
laboratory locations (Clarksburg and Bethesda, MD),
and seven clinical sites (universities, women ‘s health
centers and OB/GYN doctors offices) throughout the
state of Maryland and The District of Columbia.
BioSciCon was incorporated in 1996.
The MarkPap® product development is supported in part
by SBIR, NIH Phase-1 and Phase-2 grants and the
Montgomery County TGP Grant/Loan.
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MarkPap® Products
Commercially Available Now
 MarkPap®
TEST: Method and service.
 MarkPap® RESEARCH
KIT : A set of reagents,
instructions and control designed to facilitate the use of
the test.
 Kit
Accessories: Cytopreservative solution for
optimal enzyme and cellular preservation in extended
period of time.
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MarkPap® Research Kit
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MarkPap® Solution
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Product Features, Advantages and Benefits
Visual Biomarker


 Red,
granular
deposit inside
abnormal cervical
squamous cells.
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
1. Reduces false negative
reading to less than 4%.
2. Increases accuracy
(sensitivity/specificity) above
90%.
3. Doubles “true” positives
(cytology standard).
4. Reduces screening time
to 3 min, re-screen time to 1
min per slide.
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Combo Controls for QC/QA
MarkPap® KIT
ACCESSORY
CONTROL SLIDES
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Product Features, Advantages and Benefits
Control Slides


MarkPap® Test Kit contains
COMBO control slides.


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COMBO control slides
serve as QC/QA
Specimen processing
easily controlled
Inter-laboratory
consistency
Reduced liability
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Product Features, Advantages and Benefits
Low Cost
 Inexpensive,
simple test.
 Total
cost (material and screening) lower
then Pap. Much less expensive then
ThinPrep Pap test.
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Product Features, Advantages and Benefits
Same infrastructure as Pap Test

Immediately applicable. Based on the existing
Pap test infrastructure.
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Same lab space, equipment and personnel
(cytoprep, cytotech, pathologist). Simple and
customer friendly. Few hours training needed for
MarkPap® test.

This is an “enchanced Pap-test” and all currently
used classifications (TBS, Bethesda 2001)
apply.
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Success Ingredients
Intellectual property
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Parent patent “CAP-PAP TEST” (November 2000)
Patent pending “Cap-Pap Test Kit” (January 2003)
PCT: “MPSystem” (January 2004)
Trademark: “MarkPap®” (April 2004)
Copyright: “MarkPap® System” (December 2003)
Know-how: Clinical Laboratory Trials’ Results
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Success Ingredients
Clinical Laboratory Trial Data
RS
DN + FP
1/3
PS
FN
FP
BCC
2x
DP (TP)
RW
2x
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Cervical cancer is a preventable
disease IF detected on time
MarkPap® test improvements
 < 4% false negatives
 Doubles “true” positives
 Increases accuracy >90%
 Low cost—simple
 Increases productivity
 Lowers liability (QC/QA)
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Pap Test Market Trends
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Increase outreach among
under-served minorities in the
United States.
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Global expansion into
developing countries.
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Development of simple, low
cost methods to service large
populations.

Industrial standards and
Quality Assurance.
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Customers

Cytopathology laboratories (~3,400)
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Research laboratories

HMO

Women’s Health Centers

Doctor’s offices

DoD

WHO
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Market Opportunity
U.S.A Only
WORLD
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50 M tests annually in the U.S.

Women at risk:

3.6 M (7%) cytologically abnormal
tests


15% - 20% false negatives

13,000 newly diagnosed cervical
cancer cases
Half a million women develop
cervical cancer annually of whom
more then 50% will die. About
80% of all these women are from
the developing world.
Kills more women then childbirth.

4,500 cervical cancer deaths

40-50% HPV infected
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Potential markets:
 EU: 42 M
 World: 110 M
 At risk: 2 billion
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Product Pipeline
 MarkPap® Test: Clinical trials phase II/III.
Investigational Plan for IDE study in development.
 MarkPap® Kit, MarkPap® Solution, COMBO
Controls

All products are available in the US for research
only. Not for diagnostic use. They are available
for global marketing.
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Contact Information
BioSciCon, Inc.
14905 Forest Landing Circle
Rockville, MD 20850-2934
P/F: (301) 610-9130
www.bioscicon.com
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