White House proposes measures to speed genomic test development

Discussion in 'Biology & Genetics' started by Plazma Inferno!, Jul 7, 2016.

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    The White House announced on Wednesday measures aimed at advancing President Barack Obama's precision medicine initiative, including plans to speed the development of tests used to identify genetic mutations and guide medical treatment.
    The U.S. Food and Drug Administration said it planned to issue a proposal on Wednesday to create performance standards to guide development of next generation sequencing (NGS) tests. These tests scan a person's DNA and identify genetic differences that could be responsible for a patient's symptoms.
    The standards would be designed to assess how accurately a test identifies a genetic variant. The developer would certify that it had met those standards. Currently the FDA itself determines the test's accuracy.
    A second FDA proposal would allow test developers to use data from publicly accessible genetic databases, not just their own data, to demonstrate that the test accurately predicts disease. Califf said the approach could potentially get rid of the need for the FDA to review the tests before they reach the market.
    The FDA's action is part of a broader government initiative to promote the development of individually tailored medicines.
    As part of the project, the National Institutes of Health will invest $55 million to build the infrastructure needed to collect genetic data from more than 1 million volunteers.

    http://www.reuters.com/article/us-usa-health-precisionmedicine-idUSKCN0ZN001
     

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