Clinical Diagnostics (ClinicalDx)

What is the need?

Diagnostic products have an important and beneficial impact on the health care ecosystem. All stakeholders recognize that clinical diagnostics which guide clinical practice and allow earlier detection of many diseases and conditions are beneficial, especially in the emerging era of personalized medicine. Similar to therapeutic medical devices, the regulatory process is well established for in vitro diagnostic (IVD) products, as well as other Diagnostics; however, the regulatory process for IVD tests is seen as complex, expensive and slow.

Industry, FDA, and other stakeholders agree that collaboratively creating tools and methods based on science, that address opportunities for improvement, will benefit the entire health care system. As a result, through regulatory science based initiatives, we have an opportunity to reduce unnecessary delays and costs in delivering better diagnostic tests to help patients.

What is the goal?

MDIC 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.

What are our focus areas?

The following initiatives have been identified by our Steering Committee as projects:

Technical:

Clinical:

Who is working on this project?

MDIC has assembled a Clinical Diagnostics Steering Committee and working groups that consist of leaders from the industry, FDA, academia, and expert advisors.