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  • Regulatory NewsRegulatory News

    FDA Draft Guidance on Broader Labeling for Oncology Companion Diagnostics Draws Mixed Reactions

    Developers of companion diagnostic (CDx) tests as well as pharmaceutical and biotechnology groups and companies expressed mixed reactions to the US Food and Drug Administration (FDA) draft guidance on broader labeling of in vitro CDx assays for a specific group or class of oncology therapeutic products. The support and concerns were expressed through comments recently submitted to FDA’s draft guidance document, which was released  last December. Some commenters showe...
  • Regulatory NewsRegulatory News

    FDA, CMS: Second Parallel Review Decision Ever for NGS Test

    The US Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) on Thursday announced joint approval and coverage decisions for Foundation Medicine's FoundationOne CDx next generation sequencing (NGS) based test. The test was reviewed under FDA and CMS' parallel review program, and is only the second test to be approved and cleared under the program since its inception in 2011, the first being Exact Sciences' Cologuard colorectal cance...
  • Regulatory NewsRegulatory News

    EMA Lays out Plans for Companion Diagnostic Guideline

    The European Medicines Agency (EMA) on Friday released a concept paper for public consultation outlining issues it plans to address in an upcoming guideline on the challenges in developing companion diagnostics for personalized medicines. Specifically, EMA says its guideline will address the development of companion diagnostics for precision medicines in the clinical development and post-approval phases, and will include a glossary defining terms used in the guideline as...
  • Regulatory NewsRegulatory News

    FDA Finalizes Policy on Use, Approval of Companion Diagnostics

    The US Food and Drug Administration (FDA) has released a long-sought final guidance document on in vitro diagnostic (IVD) companion diagnostic (CDx) products—products intended to help guide the therapeutic use of new medicines based on a consumer's genetic characteristics. Background Regulators and industry have both been touting the benefits of companion diagnostics in recent years as the products have become, in the words of FDA, "more common." The benefits to both ...
  • Feature ArticlesFeature Articles

    Impact of Clinical Utility Requirements on In Vitro Diagnostic Assays

    The term "clinical utility" has come into increasingly common usage as healthcare stakeholders direct greater attention to the determination and establishment of the value of healthcare services, interventions and technologies. The meaning differs somewhat among the various stakeholders depending on their roles and interests. For example, one Medicare contractor (Palmetto) describes its requirement for evidence of clinical utility as "demonstrates change in physician trea...