Project Proposal was released in April 2018 for the Somatic Reference Sample project. The ultimate goal of the effort is to develop properly consented, widely shareable reference samples that can be made available to the public, is scalable, and produced in order to enable efficient development and improve the accuracy, reliability and transparency of NGS-based oncology tests. These samples are intended to be quality checked and validated, and made available in varying forms (e.g., cells, DNA/RNA, FFPE), represent the majority of potential variations and allele fractions of interest (e.g., ploidy, fusions, large/small indels, CNVs, homopolymeric regions), and represent tumor/normal matched pairs.
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 RFI is a request for technical information about available and possible approaches for creating a set of human cell lines that include all (or subsets of) the variants listed in ‘Priority Variant List.’ These variants are drawn from a larger list developed by the MDIC SRS working group and includes clinically actionable oncogene variants. The MDIC SRS working group is also interested to incorporate variants in tumor suppressor genes into a possible set of future reference samples.
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.
View a Q&A webinar about this Request for Proposals here.
On June 12, 2019, MDIC partnered with the Cardiovascular Research Foundation (CRF), to host an EFS symposium focused on best practices among clinicians for patient screening and enrollment in Early Feasibility Studies. The key focuses of the event included presentations on:
- Identification of relevant patient population/Patient screening
- Patient consent
- Procedural and clinical follow-up issues
Presentations from the event are now available for viewing.
MDIC’s research project intended to integrate patient preferences on benefits and risks into the statistical design of clinical trials.
MDIC announces the project in collaboration with The Michael J. Fox Foundation for Parkinson’s Research (MJFF), the US Food and Drug Administration (FDA), RTI Health Solutions, and the Massachusetts Institute of Technology (MIT).
In 2015, MDIC held a public event for the release of its Framework & Catalog of Methods for ‘Incorporating Information on Patient Preferences Regarding Benefit and Risk into the Regulatory Assessments of New Medical Technologies’. As a result of CDRH’s 2012 Guidance that discusses the importance of bringing the patient’s perspective into the CDRH benefit-risk assessments, MDIC brought together a steering committee with members from the medical device industry, government and patient centered non-profits to develop a framework for how sponsors and regulators might incorporate the patient perspective on benefit and risk. This Framework provides background on the concepts of benefit-risk and patient preference, discusses the potential value of including patient benefit-risk in a regulatory submission and when in the product lifecycle such information might be collected, outlines factors to consider when selecting a patient preference method, and discusses considerations regarding the use of patient preference information in the regulatory process.