Trusted Resource for Clinical Trials, Protocols & Progress
As precision medicine becomes a cornerstone of modern drug development, the integration of companion diagnostics (CDx) into clinical trials is no longer optional—it’s essential. A CDx is an in vitro diagnostic (IVD) device used to determine the eligibility of a patient for a specific therapy, typically by detecting a specific genetic, protein, or molecular marker.
Click to read the full article.
Precision medicine aims to deliver the right treatment to the right patient at the right time. This goal has fueled the rise of companion diagnostics (CDx), which are laboratory tests or in vitro diagnostics (IVDs) used to identify patients who are likely to benefit from a specific therapeutic product. To meet regulatory expectations and ensure market access, the co-development of drugs and companion diagnostics is now the gold standard.
Click to read the full article.
In the realm of personalized medicine, companion diagnostics (CDx) are essential tools that identify patients likely to benefit from specific therapies. These diagnostics can be developed as Laboratory Developed Tests (LDTs), performed in CLIA-certified laboratories, or as FDA-approved commercial test kits, regulated under the FDA’s Premarket Approval (PMA) process. Each approach carries unique advantages, regulatory obligations, and clinical implications.
Click to read the full article.
As precision medicine advances, companion diagnostics (CDx) have become integral to ensuring the safe and effective use of targeted therapies. However, developing a validated assay is only part of the journey—commercializing a CDx poses a host of regulatory, financial, and logistical challenges that diagnostic developers and pharmaceutical companies must address collaboratively.
Click to read the full article.
As precision medicine expands globally, the co-development and approval of companion diagnostics (CDx) has become a critical component of regulatory strategy for both pharmaceutical and diagnostic developers. Companion diagnostics guide the safe and effective use of corresponding drugs, and regulators across the world have established specific frameworks to manage their approval and post-market lifecycle.
Click to read the full article.
Companion diagnostics (CDx) are revolutionizing the clinical research and therapeutic landscape by enabling targeted patient stratification. No longer is a one-size-fits-all approach acceptable—biomarker-based stratification ensures patients receive therapies tailored to their genetic, proteomic, or molecular profiles. Whether in clinical trials or routine practice, stratification using CDx improves efficacy, reduces adverse effects, and accelerates regulatory approvals.
Click to read the full article.
Diagnostic devices are the cornerstone of modern healthcare, enabling disease detection, patient monitoring, and therapeutic decision-making. In recent years, technological advancements have dramatically transformed how diagnostics are developed, validated, and deployed. These innovations are particularly impactful in the companion diagnostics (CDx) space, where speed, accuracy, and scalability are critical to aligning diagnostic tests with precision therapies.
Click to read the full article.
Diagnostic laboratories play a vital role in generating the biomarker data necessary for patient stratification, endpoint evaluation, and treatment decision-making in clinical trials. Their integration into trial protocols is especially critical in studies involving companion diagnostics (CDx), where timely and accurate lab data drives therapeutic eligibility.
Click to read the full article.
Non-small cell lung cancer (NSCLC) has undergone a paradigm shift in treatment strategy due to the rise of companion diagnostics (CDx). These in vitro tests are used to identify patients who are likely to benefit from specific targeted therapies. Lung cancer is a model example of how CDx can drive treatment personalization, improve survival, and minimize unnecessary exposure to ineffective drugs.
Click to read the full article.
