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    Agendia - Dr. Bernhard Sixt, Ceo

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    fdablog
    Agendia's CEO Dr. Bernhard Sixt discusses the importance of patient safety and FDA regulation for diagnostic tests like MammaPrint. He notes Agendia received the first ever FDA clearance for MammaPrint in 2007 and four total clearances by 2009, showing regulation enables innovation when it provides oversight, builds confidence, and supports industry investments through transparent labeling.

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    Agendia - Dr. Bernhard Sixt, Ceo

    Uploaded by

    fdablog
    88 views1 page
    Agendia's CEO Dr. Bernhard Sixt discusses the importance of patient safety and FDA regulation for diagnostic tests like MammaPrint. He notes Agendia received the first ever FDA clearance for MammaPrint in 2007 and four total clearances by 2009, showing regulation enables innovation when it provides oversight, builds confidence, and supports industry investments through transparent labeling.

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    FDA-2010-N-0274-0056.1

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    Agendia's CEO Dr. Bernhard Sixt discusses the importance of patient safety and FDA regulation for diagnostic tests like MammaPrint. He notes Agendia received the first ever FDA clearance for MammaPrint in 2007 and four total clearances by 2009, showing regulation enables innovation when it provides oversight, builds confidence, and supports industry investments through transparent labeling.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    88 views1 page

    Agendia - Dr. Bernhard Sixt, Ceo

    Uploaded by

    fdablog
    Agendia's CEO Dr. Bernhard Sixt discusses the importance of patient safety and FDA regulation for diagnostic tests like MammaPrint. He notes Agendia received the first ever FDA clearance for MammaPrint in 2007 and four total clearances by 2009, showing regulation enables innovation when it provides oversight, builds confidence, and supports industry investments through transparent labeling.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 1

    AGENDIA – Dr.

    Bernhard Sixt,
    Sixt, CEO
    ƒ Patient safety must be priority #1

    ƒ 2007: MammaPrint first FDA IVDMIA clearance ever

    ƒ 2007-2009: 4 FDA IVDMIA clearances for MammaPrint

    ƒ Regulation enables innovation

    ƒ Industry needs to build confidence & value through FDA oversight

    ƒ Labeling must be clear and transparent

    ƒ Regulation will support investments & growth of the industry

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