The Landscape Analysis report was created from the work conducted by MDIC’s Somatic Reference Sample initiative. The Landscape Analysis subgroup was charged with conducting a thorough analysis of projects related to NGS reference samples to a) avoid duplicative efforts; b) identify gaps where the desired optimum reference samples are not yet developed or available; and c) help define specific gaps and unmet needs with respect to, for example, sample type(s), genes, variants, and so forth.  The sub-group has multiple stakeholders including reference sample manufacturers, regulatory agencies, validation study leaders, and end users of reference samples who contributed to this comprehensive summary identifying other efforts for development and evaluation of NGS reference samples which may inform and complement the SRS goals. The report is intended for the use of the diagnostic testing community for a variety of applications, including (but not limited to) assay development, test validation, and quality control.

Looking for more information? Click here to watch the MDICx on the Landscape Analysis Report that was held on March 6, 2019.

This Framework is intended to help test sponsors make decisions on how to develop credible evidence of analytical and clinical validity and clinical utility. It is a product of MDIC’s IVD Clinical Evidence Working Group.

The Framework is organized into five sections, outlined below:

Section One: Introduction – introduces the Framework, definitions of analytical validity, clinical validity, and basic concepts of FDA clearance and approval of medical devices, including IVDs.

Section Two: Analytical Validity – provides a library of tests frequently used to demonstrate analytical validity. Useful terms, test considerations and requirements, and related references are provided.

Section Three: Clinical Validity – discusses assay types and measurements of clinical validation, as well as design considerations for clinical validation based on the intended use of the IVD.

Section Four: Clinical Utility – explores the general strategy for developing evidence of clinical utility for payers, presents a clinical utility “self-assessment” framework that IVD developers can use for planning, and details additional clinical utility considerations by IVD test type.

Section Five: References – lists regulatory documents not provided in-line with the text and other references cited in this Framework.

The scope of the statement of work of this Framework is specific to the United States. This Framework should be considered an initial thought piece and not a prescriptive, “how-to” guide. Reading and following this document neither guarantees FDA approval/clearance nor payment from insurance companies.