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AMP commends SACGHS whole genome sequencing focus, raises ethical questions and forms working group
Date:6/16/2010

ical utility: AMP believes an effective approach to establishing clinical utility will depend upon a multi-disciplinary research agenda and there should be a central repository to submit clinical and analytical data of these analyses to further inform the interpretation and clinical utility of results.

  • Bioinformatics: The vast amounts of data will require investments in bioinformatics technology not only to analyze, manage and store the data, but also to enable secure access to the data in a useful manner. AMP believes measures to standardize the data for entry into interoperable electronic medical records and to simplify the reporting of sequencing results will be required to ensure responsible adoption and implementation of this technology.

  • Duty to report: AMP encourages the Committee to consider the complicated ethical issues associated with the duty to report all data, update interpretations as new evidence emerges, and the appropriateness of masking data irrelevant to the test prescriber's indication.

  • Reimbursement & Coverage: AMP believes that reimbursement policies should be modernized to appropriately represent the value of the information obtained from laboratory tests that utilize whole genome analysis (or next-generation sequencing) techniques.

  • DNA patents: As whole genome sequencing becomes more widely used in the clinical setting, DNA patents on specific sequences may restrict the reporting and interpreting of the full results of such testing. AMP fears laboratories performing whole genome sequencing will face infringement liability or risk incomplete reporting of clinically significant data.

    AMP strives to educate health professionals and the public on molecular pathology and applauds the SACGHS for releasing its draft report on Genetics Education and Training of Health Care Professionals, Public Health Providers, and Consumers. AMP intends to submit comments later this month.
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  • Contact: Mary Steele Williams
    mwilliams@amp.org
    301-634-7921
    Association for Molecular Pathology
    Source:Eurekalert

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