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Breast Cancer Diagnostic and Drug Technologies: Global Markets
Date:8/28/2012

S IN PATIENTS WITH LYMPH NODES THAT

ARE POSITIVE FOR CANCER (%) 31

TABLE 13 FIVE-YEAR SURVIVAL RATES CORRELATED WITH TUMOR STAGE (%) 31

HER2 31

COMPANION DIAGNOSTICS 32

TARGETED THERAPIES 32

PREDICTIVE DIAGNOSTICS 32

TABLE 14 PREDICTIVE DIAGNOSTIC FEATURES 32

PREDICTIVE SAFETY BIOMARKERS 33

COMMERCIALIZED BIOMARKER TESTS 33

TABLE 15 CURRENT BIOMARKER TECHNOLOGIES 34

TABLE 16 BIOMARKER USES 35

BIOMARKERS AND DRUG THERAPY 35

INCREASED USE OF BIOMARKERS IN DRUG DEVELOPMENT AND CLINICAL TRIALS 36

OBSTACLES TO BIOMARKER DEVELOPMENT 36

TABLE 17 MAJOR ISSUES AND CHALLENGES 36

BIOMARKERS TYPES 37

PREDICTIVE BIOMARKERS 37

TUMOR INTERSTITIAL FLUID BIOMARKERS 37

PHARMACOGENOMIC BIOMARKERS IN DRUG LABELS 38

BENEFITS OF PHARMACOGENOMICS 38

TABLE 18 PHARMACOGENOMICS TESTS IN USE 39

BARRIERS TO PHARMACOGENOMICS PROGRESS 39

BIOMARKERS IN DRUG LABELS 39

CLASSIFICATION OF BIOMARKERS 40

TABLE 19 BIOMARKERS FOR DRUG LABELS BASED ON SPECIFIC USE 40

TABLE 20 CANCER BIOMARKERS FOR FDA-MANDATED TESTING PRIOR TO DRUG USE 40

TABLE 21 CLINICALLY RELEVANT BIOMARKERS 40

FDA GUIDANCE 41

TABLE 22 APPROVED COMPANION DIAGNOSTICS, 2011 41

COMPANION DIAGNOSTICS AND SEVERAL REGULATORY ISSUES 43

TABLE 23 REGULATORY APPROVAL OF THE DIAGNOSTICS PATHWAY 44

FDA ROUTE 44

CLIA-BASED (LABORATORY-DEVELOPED TESTS) ROUTE 44

CHOOSING A REGULATORY PATHWAY 45

A CO-DEVELOPMENT PATH 45

ISSUES AND BARRIERS TO DEVELOPMENT 46

DRUG APPROVAL IN 2011 46

TABLE 24 APPROVED CANCER DRUGS, 2011 47

POST-LAUNCH EXPECTATIONS 47

DAKO'S EGFR IMMUNOHISTOCHEMISTRY ASSAY 47

ROLE OF REIMBURSEMENT BODIES 48

CONSIDERATIONS FOR NEW DRUG–DIAGNOSTIC PARTNERSHIPS 48

TABLE 25 FACTORS INFLUENCING THE
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