Precision Medicine for CDx Development
In the realm of precision medicine, the development of Companion Diagnostics (CDx) is pivotal. At VistaStatistics, our approach to CDx development revolves around the registrational study that supports marketing authorization, using a biomarker-selected patient population. This crucial study typically employs a Clinical Trial Assay (CTA)—either as a Laboratory Developed Test (LDT) or the final CDx assay—to determine the most responsive patient subset. While LDTs offer speed and simplicity, facilitating quicker patient enrollment by the drug sponsor, utilizing the final CDx assay from the start is regulated by agencies. This strategy enhances consistency and streamlines the regulatory pathway by eliminating the need for subsequent bridging studies.
Our services encompass a wide range of statistical inputs, including:
- Design for Drug-CDx Co-Development: Our statistical experts play a critical role in the seamless integration of drugs and companion diagnostics. By carefully planning and designing co-development strategies, we ensure that both components work harmoniously, accelerating the path to market approval.
- Bridging Study: Navigating the transition from one diagnostic assay to another can be a complex challenge. Our statistical insights ensure that bridging studies are conducted with precision, maintaining consistency and reliability in diagnostic results.
- Follow-On Study: In the post-launch phase, follow-on studies are essential to monitor and improve the performance of companion diagnostics. Our statistical expertise enables you to optimize these studies, ensuring that your diagnostics continue to meet the highest standards.
- Reproducibility Study: Ensuring that CDx device yield consistent results under varying conditions is fundamental. Our reproducibility studies are designed to evaluate the performance of your assay across different laboratories, technicians, and equipment that meet regulatory requirements. We provide comprehensive statistical analysis to establish the reliability of CDx.
- Accuracy Study: The true test of any diagnostic tool is its accuracy. Our accuracy studies are meticulously designed to measure the correctness and precision of the CDx. Through advanced statistical modeling and validation techniques, we quantify the ability of the CDx to correctly identify the presence or absence of a pharmacological target or disease marker, ensuring high confidence in clinical decision-making.
Our commitment is to leverage the power of statistics at every step, ensuring that your drug and companion diagnostics work hand-in-hand seamlessly.
By choosing Vista Statistics, you are taking a step toward precision and excellence in companion diagnostics, unlocking the potential to revolutionize personalized medicine. Discover how our statistical expertise can empower your Companion Diagnostics journey for success.