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  • Establishment of the Australian In Situ Hybridization Program for the Assessment of HER2 Amplification in Breast Cancer: A Model for the Introduction of New Biomarkers Into Clinical Practice

    Author(s)
    Farshid, G
    Armes, JE
    Bell, R
    Cummings, M
    Fox, S
    Francis, G
    Haswell, M
    Morey, A
    Mccue, G
    Raymond, W
    Robbins, P
    Bilous, M
    Griffith University Author(s)
    Francis, Glenn D.
    Year published
    2010
    Metadata
    Show full item record
    Abstract
    n August 2006, the Australian government announced a decision to subsidize trastuzumab therapy for early breast cancer, to commence 6 weeks later. It was mandated that HER2 gene amplification, determined by in situ hybridization (ISH), be shown, and that the sponsor company, Roche Products Pty Ltd, should fund this testing. This announcement potentially required provision of ISH testing for HER2 for every newly diagnosed breast cancer, where previously HER2 testing had been performed by immunohistochemistry with support from a single fluorescence ISH (FISH) reference laboratory for indeterminate cases. The Australian ...
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    n August 2006, the Australian government announced a decision to subsidize trastuzumab therapy for early breast cancer, to commence 6 weeks later. It was mandated that HER2 gene amplification, determined by in situ hybridization (ISH), be shown, and that the sponsor company, Roche Products Pty Ltd, should fund this testing. This announcement potentially required provision of ISH testing for HER2 for every newly diagnosed breast cancer, where previously HER2 testing had been performed by immunohistochemistry with support from a single fluorescence ISH (FISH) reference laboratory for indeterminate cases. The Australian HER2 Testing Advisory Board, an independent expert group, responded to the challenge of rapidly providing accurate nationwide ISH testing. Bright-field ISH was selected as the testing platform and a decentralized testing model, with support from a central FISH laboratory, was adopted. An implementation plan was developed addressing standards for training, accreditation, and quality assurance. Within 6 weeks, 8 pathology laboratories were accredited for ISH testing and by September 2008, 2 years after the announcement, 22 ISH testing laboratories were taking part in the national program and almost 20,000 ISH tests had been performed. This article describes the design and rapid implementation of a nationwide program of bright-field ISH as the first-line testing platform for HER2 status in early breast cancer. We believe that this model for the coordinated and large-scale implementation of a new biomarker test has wide application, given that accurate assessment of a range of novel biomarkers is being used increasingly to determine eligibility for new targeted treatment modalities.
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    Journal Title
    Diagnostic Molecular Pathology
    Volume
    19
    Issue
    4
    DOI
    https://doi.org/10.1097/PDM.0b013e3181e1cc9d
    Subject
    Clinical sciences
    Publication URI
    http://hdl.handle.net/10072/37057
    Collection
    • Journal articles

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