• Regulatory NewsRegulatory News

    Evaluating Next-Generation Sequencing: From Design Concept to Performance Standards

    Discussions are underway on how the US Food and Drug Administration (FDA) plans to develop new ways of regulating next-generation sequencing (NGS) diagnostics. Kicking off a two-day public workshop today, FDA Commissioner nominee Robert Califf said that NGS tests hold great promise for patients, but still present "tremendous uncertainty." The issue, he said, is determining "how accurate [and] how useful can we make the predictions that come from these tests." Califf als...
  • Regulatory NewsRegulatory News

    FDA Looks to Develop Regulatory Strategies for Genomic Testing

    To further the president's Precision Medicine Initiative (PMI), the US Food and Drug Administration (FDA) is working to develop regulatory systems for diagnostics using next generation sequencing (NGS) technologies. Background Since 2014, FDA has sought input from the public on how it could develop a regulatory system appropriate for reviewing and regulating NGS technologies. The agency says it believes such a system "could potentially be applied to many other types o...
  • Regulatory NewsRegulatory News

    precisionFDA: A Crowd-Sourced, Cloud-Based Platform for Precision Medicine

    The US Food and Drug Administration (FDA) has announced the launch of a new crowd-sourced, cloud-based platform, precisionFDA, to enable developers of genomic sequencing diagnostics to share data and methodologies. precisionFDA In a post to FDA Voice Wednesday, FDA Chief Health Informatics Officer Taha Kass-Hout and Policy Advisor for the Office of In Vitro Diagnostics and Radiological Health David Litwack laid out the plan and goals for precisionFDA. The new platfo...
  • Genome Sequencing Costs Set To Plunge Below $1,000 For The First Time

    • 10 January 2012
    A Connecticut company, Life Technologies Corp, is announcing that they have manufactured a machine that has  broken the $1,000 genome sequencing barrier that has long been seen as a milestone in providing affordable sequencing technologies to the public. The machine itself is set to cost between $99,000 and $149,000-well below the $750,000 that some current genome sequencing models cost. The machine reportedly uses materials that can sequence the an entire human ge...