MarkPap® TECHNOLOGY Focal Points BioSciCon, Inc. 12/31/2018.

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Presentation transcript:

MarkPap® TECHNOLOGY Focal Points BioSciCon, Inc. 12/31/2018

Focal Points Technology Overview Company Overview MarkPap® Products Pap Test Market 12/31/2018

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. : 12/31/2018

PAPANICOLAOU STAINING OF A CONVENTIONAL PAP SMEAR AND A THINPREP PAP TEST THIN-LAYER 12/31/2018

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 12/31/2018

MarkPap® Test BIOMARKER 12/31/2018

MarkPap® Test BIOMARKER BIOMARKER 12/31/2018

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 12/31/2018

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. 12/31/2018

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. 12/31/2018

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. 12/31/2018

MarkPap® Research Kit 12/31/2018

MarkPap® Solution 12/31/2018

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. 12/31/2018

Combo Controls for QC/QA MarkPap® KIT ACCESSORY CONTROL SLIDES 12/31/2018

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 12/31/2018

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. 12/31/2018

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. 12/31/2018

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 12/31/2018

Success Ingredients Clinical Laboratory Trial Data RS DN + FP 1/3 FP PS FN BCC 2x DP (TP) RW 2x 12/31/2018

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) 12/31/2018

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. 12/31/2018

Customers Cytopathology laboratories (~3,400) Research laboratories HMO Women’s Health Centers Doctor’s offices DoD WHO 12/31/2018

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 12/31/2018

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. 12/31/2018

Contact Information BioSciCon, Inc. 14905 Forest Landing Circle Rockville, MD 20850-2934 P/F: (301) 610-9130 www.bioscicon.com 12/31/2018