Cancer Genomic Somatic Reference Samples


Project Goal: Develop reference samples that can be made available to the public to improve the accuracy, reliability and transparency of NGS-based oncology tests.


Project Impact:

  • Aid in efficient NGS test development and validation
  • Streamline and possibly obviate steps in the regulatory process for diagnostic companies
  • Provide transparency
  • Compress development timelines for targeted therapeutics developers

The Medical Device Innovation Consortium (MDIC) is seeking proposals submitted from organizations for assistance with the provision of Services in preparing somatic reference samples described in Addendum 1 as part of the MDIC Somatic Reference Samples (SRS) Project. The focus of the MDIC SRS Project is to guide the development of reference samples that can be used to develop or validate Next Generation Sequencing (NGS)-based oncologic tests. The absence of well-characterized and community-validated somatic/tumor variant reference samples and data benchmarks create challenges for the efficient development of these critical tests and appropriate clinical decisions for patients with cancer. Download a copy of the RFP here. An informational webinar was held on September 11. View the archived webinar here.

 A subgroup of the MDIC SRS Working Group was established to identify variants or other targets (e.g., genomic signatures) that would be included in an ideal set of somatic reference samples for clinically actionable oncogene variants in solid tumors. Download the list of priority variants here

Looking to view the report? Visit our resource page to download a copy!