Direct Hit Power Point Presentation

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DirectHit ® Test Panel for Breast Cancer www.cccdiag.com A Personalized Approach to Anticancer Therapy ®

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CCC Diagnostics Our mission: To create innovative approaches to cancer disease management by integrating discoveries in diagnostic, therapeutic and information technologies. CCC Diagnostics was founded in 2004 by a group of former researchers at Johns Hopkins University, including the late Dr. Paul Ts’o, former Director of the Biophysics Div. of JHU School of Public Health. 2

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THE CHALLENGE Current treatments…30-50% effective Significant side effects Annual costs can exceed $30,000 per patient Effective treatment relies on drug selection No way to select personalized chemotherapy 3

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CURRENT TESTING LANDSCAPE Routine testing IHC/FISH ER/PR  Hormonal therapy Her-2  Trastuzumab Oncotype Dx Recurrence after surgery MammaPrint/TargetPrint Recurrence after surgery ER/PR/HER-2 status No tests available to determine best chemotherapy regimen

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DirectHit ® Biomarkers Drugs - FDA approved, NCCN recommended Clinical literature support links drug and biomarkers DRUG BIOMARKERS Antiestrogens Estrogen Receptor Taxanes/Vinca Alkaloids Beta-Tubulin III 5 FU Thymidylate Synthase Trastuzumab HER2/neu Gemcitibine* Ribonucleotide Reductase Anthracyclines * Topoisomerase IIα Platinum Drugs* ERCC-1 * DirectHit® assays in development

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THE SOLUTION Diagnostic service for individual patients Predicts response to chemotherapy/hormonal drugs Excludes ineffective drug treatments Enables personalized treatment selection

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DirectHit ® Technology Quantitative immunofluorescence analysis Simultaneous analysis of 4 biomarker classes Correlates biomarker expression with clinical response Cytokeratin stain

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HER-2 DirectHit ® is a Test Panel - includes in one test: ER, HER-2 Biomarkers for commonly used chemotherapy drugs Thymidylate Synthase IHC/FISH Estrogen Receptor Beta- Tubulin Ill HER-2 Estrogen Receptor DirectHit ® Test Panel for Breast Cancer

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DirectHit ® Methods FFPE Tissue Biomarkers 1. Slide Processing 2. Imaging 4. DRI Expression 3. Cancer Cell ID

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DirectHit ® Prediction Accuracy Hormonal Treatment DirectHit ® is more accurate than standard methods 0                           20                                         40                               60                                80                             100 IHC 68%* DirectHit ® 94% Response Rate * Based on ongoing retrospective clinical trials

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DirectHit ® Prediction Accuracy Trastuzumab Treatment DirectHit ® is more accurate than standard methods 0                           20                                     40                               60                                80                              100 IHC 44%* DirectHit ® 100% Response Rate * Based on ongoing retrospective clinical trials

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DirectHit ® Prediction Accuracy DirectHit ® accurately predicts response to: Antiestrogens and Trastuzumab Response Rate Resistant Accuracy 100% Resistant Accuracy 100% Sensitive Accuracy 94%

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DirectHit ® Prediction Accuracy DirectHit ® accurately predicts response to chemotherapy Response Rate

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DirectHit ® Results Summary High degree ER measurement accuracy Accurate chemotherapy response Able to identify ineffective treatments Drug Class Biomarker Other Tests Response Rate DirectHit Response Rate Antiestrogens Estrogen Receptor 68%* 94% Trastuzumab HER-2/neu 44%* 100% Taxanes/ Vinca Alkaloids beta-tubulin III Not available 88% 5FU/Xeloda Thymidylate Synthase Not available 85% * Based on ongoing retrospective clinical trials

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Single drug treatment - Taxotere Assumption = 50% efficacy Drug Cost/100 patients = $1.75 M Drug Savings/50 resistant patients = $878,850 Cost Savings DirectHit ® Test Panel for Breast Cancer

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Unique Attributes of DirectHit Quantitative immunofluorescent (QIF) based analysis Standardized measurements Five signals/cell can be analyzed Tissue structure and topography preserved Only commercial test to apply QIF to protein biomarkers Proprietary patient database for interpretation ®

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DirectHit ® Ordering Process Obtain requisition form from website or contact CCC Diagnostics Complete Requisition Form Fax the completed Requisition Form to CCC Diagnostics Account registration by CCC Diagnostics Customer Service Verify patient's insurance coverage Sample collection kit will be sent to designated location via FedEx Provide (6) slides from patients formalin fixed, paraffin embedded tissue Return to CCC Diagnostics via supplied FedEx package Results sent to the physician within six business days of scheduled test date

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DirectHit ® as a Diagnostic Service will: Individualize anticancer therapy selection Lessen exposure to ineffective therapies Reduce potential side effects Save significant treatment costs Improve quality of life Benefits for Patients DirectHit ® Test Panel for Breast Cancer

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THE FUTURE Expanded breast cancer biomarker selection Expanded health insurance coverage Extension of DirectHit ® platform to GI cancer Retrospective trials in progress Commonly used chemotherapy drugs Preliminary results = 85% predictive accuracy

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CONTACTS Website – cccdiag.com Customer Service – 410-633-4885 x1002 Email – customerservice@cccdiag.com Technical Questions – 410-633-4885 x1071