DirectHit® Test Panel for

Breast Cancer

www.cccdiag.com

A Personalized Approach to Anticancer Therapy

®

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

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 o ER/PR Hormonal therapyo Her-2 Trastuzumab

• Oncotype Dxo Recurrence after surgery

• MammaPrint/TargetPrinto Recurrence after surgeryo ER/PR/HER-2 status

No tests available to determine best chemotherapy regimen

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

THE SOLUTION

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

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

Cytokeratin stain

HER-2

• DirectHit® is a Test Panel - includes in one test: o ER, HER-2o Biomarkers for commonly used chemotherapy drugs

ThymidylateSynthase

IHC/FISHEstrogenReceptor

Beta-Tubulin Ill

HER-2EstrogenReceptor

DirectHit® Test Panel for Breast Cancer

DirectHit® Methods

FFPE Tissue Biomarkers

1. Slide Processing 2. Imaging

4. DRI Expression 3. Cancer Cell ID

DirectHit® Prediction AccuracyHormonal 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

DirectHit® Prediction AccuracyTrastuzumab 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

DirectHit® Prediction Accuracy

DirectHit® accurately predicts response to:Antiestrogens and Trastuzumab

Response Rate

Resistant Accuracy 100%

Resistant Accuracy 100%

Sensitive Accuracy 94%

DirectHit® Prediction Accuracy

DirectHit® accurately predicts response to chemotherapy

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/XelodaThymidylate

SynthaseNot available 85%

* 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

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 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

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

THE FUTURE

• Expanded breast cancer biomarker selection

• Expanded health insurance coverage

• Extension of DirectHit® platform to GI cancero Retrospective trials in progresso Commonly used chemotherapy drugso Preliminary results = 85% predictive accuracy

CONTACTS

• Website – cccdiag.com

• Customer Service – 410-633-4885 x1002

• Email – customerservice@cccdiag.com

• Technical Questions – 410-633-4885 x1071