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The European Union’s In Vitro Diagnostic Medical Devices Regulation (IVDR, Regulation (EU) 2017/746) replaced the previous IVDD (Directive 98/79/EC) and entered into force on May 26, 2022. The IVDR introduces significant changes in the classification, conformity assessment, performance evaluation, and clinical evidence requirements for in vitro diagnostics (IVDs), including companion diagnostics (CDx).
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As the pharmaceutical market continues to expand across Asia-Pacific (APAC), countries like Japan, China, South Korea, and Australia have introduced specific regulatory frameworks for companion diagnostics (CDx). For global clinical trials and commercialization strategies, understanding the approval processes under authorities such as Japan’s PMDA (Pharmaceuticals and Medical Devices Agency) is essential.
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As personalized medicine becomes mainstream, companion diagnostics (CDx) play a critical role in selecting the right therapy for the right patient. However, regulatory authorities across the globe have distinct timelines, technical requirements, and processes for approving a drug and its associated diagnostic. These differences can hinder the simultaneous global launch of precision therapies.
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Companion diagnostics (CDx) are essential tools for personalized medicine. From initial clinical validation to ongoing performance monitoring, CDx developers must address both pre-market and post-market regulatory requirements. Each stage comes with specific documentation, compliance obligations, and regulatory interactions, especially across agencies like the FDA, EMA, and PMDA.
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Companion diagnostics (CDx) are essential in ensuring targeted therapies reach the right patients. However, global approval pathways involve distinct submission formats, timelines, and regulatory expectations. Without structured timeline management, developers risk delays in therapy launches, regulatory rejections, and increased costs.
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Labeling for companion diagnostics (CDx) is more than just a product insert — it’s a critical regulatory document that links the diagnostic to its intended therapeutic product. Regulatory authorities such as the FDA, EMA, and PMDA place significant emphasis on precise, consistent, and evidence-supported labeling to avoid misleading claims and ensure safe use.
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In companion diagnostics (CDx) and other regulated in vitro diagnostics (IVDs), a bridging study demonstrates that results obtained with a new test system, cut-off, matrix, site, or population are clinically and analytically comparable to those used to generate pivotal evidence. Sponsors use bridging when moving from a development assay to a commercial kit, from one instrument or reagent lot to another, or when seeking approval in a new region where local conditions or populations differ. The goal is to show that the medical decisions derived from the “bridged” configuration are as safe and effective as those from the reference configuration.
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An Investigational Device Exemption (IDE) allows a diagnostic device—such as a companion diagnostic (CDx), imaging agent readout, or standalone in vitro diagnostic (IVD)—to be used in a clinical investigation to collect safety and effectiveness data. In drug development, diagnostics frequently determine patient eligibility, stratify cohorts, or guide dosing. If the test result will influence a subject’s medical care or enrollment in a way that could pose risk, U.S. regulations generally require IDE oversight. Sponsors (device manufacturers or drug co‑developers) are responsible for design control, monitoring, safety reporting, and quality management, while investigators and sites implement the protocol and protect subjects under IRB oversight and informed consent requirements.
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Real‑world evidence (RWE) refers to clinical insights generated from data collected outside tightly controlled trials—such as electronic health records (EHRs), laboratory information systems (LIS), claims, registries, biobanks, and pragmatic or decentralized studies. For companion diagnostics (CDx) and other IVDs, RWE can confirm performance in diverse practice settings, characterize rare variants or phenotypes, and demonstrate that an assay’s real‑world use supports the same medical decisions described in its labeling. Regulators increasingly accept well‑designed RWE to complement clinical performance studies, justify label expansions (e.g., new tumor types or specimen matrices), or support bridging when a trial‑stage assay differs from the marketed configuration. Crucially, RWE is not a shortcut; agencies expect traceable provenance, pre‑specified analysis plans, and bias‑mitigation strategies that elevate observational data to decision‑grade evidence.
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