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Regulatory considerations for companion diagnostic devices

Eunice Y Lee1, Hsin-Chieh Jennifer Shen

  • 1Division of Molecular Genetics & Pathology, Office of In Vitro Diagnostics & Radiological Health, Center for Devices & Radiological Health, US FDA, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.

Biomarkers in Medicine
|January 22, 2015
PubMed

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Keywords:
assaybiomarkercodevelopmentin vitro companion diagnosticmedical devicepersonalized medicineprecision medicineregulation