News & Analysis as of

Is Next Generation Sequencing Ready for Personalized Medicine?

Next generation sequencing (NGS) promises to transform the delivery of health care by providing in one test diagnostic and prognostic information that had previously only been available in multiple analyses. One application...more

BIO IPDx Symposium Highlights Uncertainty in Diagnostic Patenting

On July 22, BIO hosted the first IP and Diagnostics (IPDx) Symposium in Alexandria, Virginia, which was organized to open a dialogue regarding the latest developments in diagnostics and personalized medicine. The symposium...more

FDA Regulation of Laboratory Developed Tests: Benefit or Unnecessary Burden?

The U.S. Department of Food and Drug Administration (“FDA”) has previously announced an interest in regulating diagnostic tests used in providing personalized medicine clinical care. Interested stakeholders such as the...more

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