MDICx: IVD Clinical Evidence Framework – from the MDIC Clinical Diagnostics IVD Clinical Evidence Working Group
August 13, 2019, 12 p.m. ET/ 11 a.m. CT/ 9 a.m. PT
Market entry for an IVD test requires evidence of analytical and clinical validity: how well the test predicts the presence, absence or risk of a specific condition in order to get the analyte cleared or approved by FDA. Payer coverage and provider adoption also require evidence of clinical utility: whether the information that a test provides is useful to improve the management and outcome of a condition. This framework will help test sponsors make decisions on how to develop credible evidence of analytical and clinical validity and clinical utility. The scope of the statement of work is specific to the United States.
The framework outlines:
- Analytical validity: the ability of an in vitro diagnostic to identify, detect, measure, calculate, or analyze one or more measurands to support its intended use and the type of analytical data required to support the claims.
- The elements of defining clinical validity; the ability of an in vitro diagnostic product to identify, measure, predict, monitor, screen, prevent, or otherwise diagnose, or assist in selecting treatment for, a disease or condition in humans through the identification, detection, measurement, calculation, or analysis of one or more measurands to support its intended use and the type of clinical data required to support the claims.
- The elements of defining clinical utility; how the elements can be applied to specific clinical settings and the types of evidence required to support potential claims of clinical utility.
Key Topics include:
- MDIC Public-Private Partnership
- Overview of the framework
- Highlights from:
- Analytical Validity
- Clinical Validity
- Clinical Utility
- Dialogue on IVD clinical evidence considerations
- Timothy Stenzel, MD, PhD | Director, FDA | CDRH | OHT7: OIR
- Louis Jacques, MD | Chief Clinical Officer, ADVI
- Jaime Houghton, MS, MT – Sr. Director RA and Clinical Affairs, Sysmex Americas
Download the full framework here.