• Regulatory NewsRegulatory News

    MDIC Works to Standardize Oversight of NGS-based Assays

    To advance the regulatory science of diagnostic testing and assay development, the Medical Device Innovation Consortium (MDIC) posted a new landscape analysis report Wednesday to provide a snapshot of all known projects related to next-generation-sequencing (NGS) oncology reference samples.   The landscape analysis report serves as a catalog of information on 35 projects marked as either completed, ongoing or under development. Projects were divided into five categorie...
  • Regulatory NewsRegulatory News

    Proposed Precertification Approach on In Vitro Clinical Tests Raises Questions

    Comments submitted to Congress on a recent discussion draft for a new risk-based approach to the regulation of in vitro clinical tests (IVCTs) raised questions and concerns around the IVCT precertification framework. The IVCT draft legislation would provide regulatory standardization for FDA-reviewed tests and laboratory developed tests (LDTs)—most of which do not meet the same standards in analytical and clinical validation—whereas IVCT precertification would enable ...
  • Regulatory NewsRegulatory News

    Diagnostics: Bipartisan Duo Offers Bill to Alter Regulations

    The ongoing overhaul of diagnostic and lab-developed test (LDT) regulations turned another corner last week, with Reps. Larry Bucshon, M.D. (R-IN) and Diana DeGette (D-CO) releasing a discussion draft of a bill that would offer a new direction for the US Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS). The 215-page discussion draft, known as the Diagnostic Accuracy and Innovation Act (DAIA), draws some similarities to another dr...