1. MarkPap® TECHNOLOGY
Focal Points
BioSciCon, Inc.
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2. Focal Points Technology Overview Company Overview MarkPap® Products
Pap Test Market
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3. 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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4. PAPANICOLAOU STAINING OF A CONVENTIONAL PAP SMEAR AND A THINPREP PAP TEST THIN-LAYER
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5. 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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6. MarkPap® Test
BIOMARKER
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7. MarkPap® Test
BIOMARKER
BIOMARKER
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8. 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
MarkPap® Processor
Under development
MarkPap® Workstation
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9. 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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10. 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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11. 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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12. MarkPap® Research Kit
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13. MarkPap® Solution
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14. Product Features, Advantages and Benefits Visual Biomarker
Red, granular deposit inside abnormal cervical squamous cells.
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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15. Combo Controls for QC/QA
MarkPap® KIT
ACCESSORY
CONTROL SLIDES
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16. Product Features, Advantages and Benefits Control Slides
MarkPap® Test Kit contains COMBO control slides.
COMBO control slides serve as QC/QA
Specimen processing easily controlled
Inter-laboratory consistency
Reduced liability
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17. 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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18. Product Features, Advantages and Benefits Same infrastructure as Pap Test
Immediately applicable. Based on the existing Pap test infrastructure.
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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19. Intellectual property
Success Ingredients
Intellectual property
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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20. Success Ingredients Clinical Laboratory Trial DataRS
DN + FP
1/3 FP PS FN
BCC 2x
DP (TP) RW 2x
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21. 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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22. Pap Test Market Trends
Increase outreach among under-served minorities in the United States.
Global expansion into developing countries.
Development of simple, low cost methods to service large populations.
Industrial standards and Quality Assurance.
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23. Customers Cytopathology laboratories (~3,400) Research laboratories
HMO
Women’s Health Centers
Doctor’s offices
DoD
WHO
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24. Market Opportunity U.S.A Only WORLD 50 M tests annually in the U.S.
3.6 M (7%) cytologically abnormal tests
15% - 20% false negatives
13,000 newly diagnosed cervical cancer cases
4,500 cervical cancer deaths
40-50% HPV infected
WORLD
Women at risk:
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.
Potential markets:
EU: 42 M
World: 110 M
At risk: 2 billion
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25. 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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26. Contact Information
BioSciCon, Inc.
14905 Forest Landing Circle
Rockville, MD
P/F: (301)
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