Overview of Program:
The Clinical Diagnostics (CDx) program aims to identify and pursue projects that will improve diagnostic testing and product development using novel regulatory science approaches developed through collaboration between MDIC stakeholders. Providing a predictable path for innovation will help patients benefit through quicker access to more cost-effective advanced diagnostic technologies in less time.
The CDx Program is focused on:
- Establishing a foundation where surrogate samples can support product development with an initial focus on studies to support product submissions.
- Developing and defining clear analytical validity study designs for Point of Care devices that use fingerstick capillary blood specimens.
- Developing reference samples that can be made available to the public to improve the accuracy, reliability and transparency of NGS-based oncology tests.
- Creating an evidence framework that test sponsors can use to make decisions on how to develop credible evidence of analytical and clinical validity and clinical utility.
- Building a framework for utilizing real-world data as a source of evidence that can be used to support regulatory and reimbursement decision-making for in vitro diagnostics.