DirectHit® Test Panel forBreast 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.

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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

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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 ReceptorTaxanes/Vinca Alkaloids Beta-Tubulin III

5 FU Thymidylate SynthaseTrastuzumab HER2/neuGemcitibine* Ribonucleotide Reductase

Anthracyclines * Topoisomerase IIαPlatinum Drugs* ERCC-1

* DirectHit® assays in development5

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

ThymidylateSynthase

IHC/FISH EstrogenReceptor

Beta-Tubulin Ill

HER-2EstrogenReceptor

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DirectHit® Test Panel for Breast Cancer

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 TreatmentDirectHit® 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

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Response Rate

Resistant Accuracy 100%

Resistant Accuracy 100%

Sensitive Accuracy 94%

DirectHit® Prediction Accuracy

DirectHit® accurately predicts response to chemotherapy

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Response Rate

DirectHit® Results Summary

• High degree ER measurement accuracy• Accurate chemotherapy response• Able to identify ineffective treatments

Drug Class Biomarker Other TestsResponse

Rate

DirectHitResponse

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%

14* Based on ongoing retrospective clinical trials

• Single drug treatment - Taxotere• Assumption = 50% efficacy• Drug Cost/100 patients = $1.75 M• Drug Savings/50 resistant patients = $878,850

Cost Savings

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DirectHit® Test Panel for Breast Cancer

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 interpretation16

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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

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DirectHit® Test Panel for Breast Cancer

THE FUTURETHE 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

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