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Slide 1: ® DirectHit® Test Panel for Breast Cancer A Personalized Approach to Anticancer Therapy www.cccdiag.com
Slide 2: 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
Slide 3: 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
Slide 4: CURRENT TESTING LANDSCAPE • Routine testing IHC/FISH o ER/PR e o Her-2 e • Oncotype Dx o Recurrence after surgery • MammaPrint/TargetPrint o Recurrence after surgery o ER/PR/HER-2 status No tests available to determine best chemotherapy regimen
Slide 5: DirectHit® Biomarkers • Drugs - FDA approved, NCCN recommended • Clinical literature support links drug and biomarkers DRUG Antiestrogens Taxanes/Vinca Alkaloids 5 FU Trastuzumab Gemcitibine* Anthracyclines * Platinum Drugs* * DirectHit® assays in development BIOMARKERS Estrogen Receptor Beta-Tubulin III Thymidylate Synthase HER2/neu Ribonucleotide Reductase Topoisomerase IIα ERCC-1
Slide 6: THE SOLUTION • • • • Diagnostic service for individual patients Predicts response to chemotherapy/hormonal drugs Excludes ineffective drug treatments Enables personalized treatment selection
Slide 7: DirectHit Technology ® • Quantitative immunofluorescence analysis • Simultaneous analysis of 4 biomarker classes • Correlates biomarker expression with clinical response Cytokeratin stain
Slide 8: DirectHit® Test Panel for Breast Cancer • DirectHit® is a Test Panel - includes in one test: o o ER, HER-2 Biomarkers for commonly used chemotherapy drugs IHC/FISH Estrogen Receptor HER-2 Estrogen Receptor Thymidylate Synthase HER-2 BetaTubulin Ill
Slide 9: DirectHit® Methods 1. Slide Processing 2. Imaging FFPE Tissue Biomarkers 4. DRI Expression 3. Cancer Cell ID
Slide 10: DirectHit Prediction Accuracy ® Hormonal Treatment DirectHit® is more accurate than standard methods IHC 68%* DirectHit® 94% 0                           20                                         40                               60                                80                        Response Rate * Based on ongoing retrospective clinical trials
Slide 11: DirectHit Prediction Accuracy ® Trastuzumab Treatment DirectHit® is more accurate than standard methods IHC 44%* DirectHit® 100% 0                           20                                     40                               60                                80                              100 * Based on ongoing retrospective clinical trials Response Rate
Slide 12: DirectHit Prediction Accuracy ® DirectHit® accurately predicts response to: Antiestrogens and Trastuzumab Resistant Accuracy 100% Sensitive Accuracy 94% Resistant Accuracy 100% Response Rate
Slide 13: DirectHit Prediction Accuracy ® DirectHit® accurately predicts response to chemotherapy Response Rate
Slide 14: DirectHit Results Summary ® • High degree ER measurement accuracy • Accurate chemotherapy response • Able to identify ineffective treatments Drug Class Antiestrogens Trastuzumab Taxanes/ Vinca Alkaloids 5FU/Xeloda Biomarker Estrogen Receptor HER-2/neu beta-tubulin III Thymidylate Synthase Other Tests Response Rate 68%* 44%* Not available Not available DirectHit Response Rate 94% 100% 88% 85% * Based on ongoing retrospective clinical trials
Slide 15: DirectHit® Test Panel for Breast Cancer Cost Savings • • • • Single drug treatment - Taxotere Assumption = 50% efficacy Drug Cost/100 patients = $1.75 M Drug Savings/50 resistant patients = $878,850
Slide 16: 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
Slide 17: 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
Slide 18: DirectHit® Test Panel for Breast Cancer Benefits for Patients 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
Slide 19: THE FUTURE • Expanded breast cancer biomarker selection • Expanded health insurance coverage • Extension of DirectHit® platform to GI cancer o o o Retrospective trials in progress Commonly used chemotherapy drugs Preliminary results = 85% predictive accuracy
Slide 20: CONTACTS • Website – cccdiag.com • Customer Service – 410-633-4885 x1002 • Email – customerservice@cccdiag.com • Technical Questions – 410-633-4885 x1071