Perspective for the development of companion diagnostics and regulatory landscape to encourage personalized medicine in Japan

Breast Cancer

Volumn 23, Issue 1, 2016, Pages 19-23

  Tazawa, Yoshiaki ^a  

^a Roche Diagnostics KK   (Japan)

Author keywords

Clinical laboratory improvement amendments (CLIA); Companion diagnostics (CDx); Laboratory developed tests (LDTs); Next generation sequencer (NGS); Quality management of clinical laboratory testing

Indexed keywords

BIOLOGICAL MARKER; EPIDERMAL GROWTH FACTOR RECEPTOR; K RAS PROTEIN; ANTINEOPLASTIC AGENT; DIAGNOSTIC KIT;

ARTICLE; CANCER THERAPY; CLINICAL PRACTICE; CLINICAL TRIAL (TOPIC); COMPANION DIAGNOSTIC; DIAGNOSTIC PROCEDURE; DNA SEQUENCE; DRUG EFFICACY; DRUG SAFETY; HEALTH CARE QUALITY; HUMAN; JAPAN; LABORATORY TEST; MEDICAL TECHNOLOGY; MOLECULAR DIAGNOSTICS; MOLECULARLY TARGETED THERAPY; NEXT GENERATION SEQUENCING; PERSONALIZED MEDICINE; PRACTICE GUIDELINE; PRIORITY JOURNAL; RISK ASSESSMENT; DIAGNOSTIC KIT; DRUG DEVELOPMENT; FOOD AND DRUG ADMINISTRATION; GENETICS; HEALTH CARE POLICY; HIGH THROUGHPUT SEQUENCING; METABOLISM; MOLECULAR PATHOLOGY; NEOPLASMS; UNITED STATES;

ANTINEOPLASTIC AGENTS; DRUG DISCOVERY; HEALTH POLICY; HIGH-THROUGHPUT NUCLEOTIDE SEQUENCING; HUMANS; JAPAN; MOLECULAR TARGETED THERAPY; NEOPLASMS; PATHOLOGY, MOLECULAR; PRECISION MEDICINE; REAGENT KITS, DIAGNOSTIC; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84952875120     PISSN: 13406868     EISSN: 18804233     Source Type: Journal    
DOI: 10.1007/s12282-015-0586-y     Document Type: Article

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