MDIC Somatic Reference Samples to Support Laboratory Performance Monitoring in NCI’s ComboMATCH Clinical Trial

Washington, D.C.  October 22, 2025 — The Medical Device Innovation Consortium (MDIC) is proud to announce that its reference samples developed through the Somatic Reference Samples (SRS) Initiative will be used to monitor laboratory performance in the National Cancer Institute’s (NCI) ComboMATCH clinical trial, a precision medicine initiative aimed at matching cancer patients with targeted therapies based on the genetic profile of their tumors. The Somatic Reference Samples (SRS) Initiative is a public-private partnership convened by MDIC including FDA, NIH, NIST, CDC, and diagnostics manufacturers, guiding the development of reference samples that can be used to develop and validate NGS-based cancer diagnostics.

ComboMATCH, a large precision oncology successor to NCI’s Molecular Analysis for Therapy Choice (MATCH) trial, relies on accurate and consistent genomic testing through a network of Designated Laboratories (DLs) to ensure patients are matched with the most appropriate investigational treatments. To support this effort, MDIC’s somatic reference samples—developed through its collaborative public-private partnership—will serve as standardized materials to assess and ensure the quality and reliability of genomic testing performed by DLs.

“These reference samples represent a critical advancement in quality assurance for precision oncology,” said Maryellen de Mars, Head of the Center for Manufacturing Innovation and Quality at MDIC. “By providing laboratories with well-characterized, reproducible materials, we can help ensure that genomic testing results are consistent and trustworthy across sites, ultimately improving patient outcomes and confidence in trial data.”

The Molecular Characterization Laboratory at the Frederick National Laboratory for Cancer Research is supporting ComboMATCH and will be charged with distributing the reference samples across the more than 30 participating laboratories, collecting variants results, and performing concordance analysis.

“Laboratories that are part of the DL network are regularly monitored to ensure performance continues to meet our standards. When monitoring the labs, it is important to send the same set of well-characterized reference samples to each lab to ensure the labs meet the concordance requirements for referring patients to ComboMATCH,” said Li Chen, Ph.D., MoCha Head of Bioinformatics.

The use of MDIC’s somatic reference samples in ComboMATCH reflects a shared commitment to innovation, collaboration, and scientific rigor. Developed with input from regulatory agencies, industry leaders, and academic experts, the samples are designed to mimic the complexity of tumor DNA and provide a benchmark for evaluating assay performance.

MDIC’s involvement in ComboMATCH underscores its mission to advance regulatory science and accelerate access to safe and effective medical technologies. This initiative also highlights the importance of cross-sector collaboration in driving forward the future of personalized medicine.

For more information about MDIC’s reference sample program or the ComboMATCH trial, please visit www.mdic.org or www.cancer.gov.

About FNL (Frederick National Laboratory for Cancer Research)

FNL is the only U.S. national laboratory exclusively dedicated to biomedical research. Our research focuses on cancer, HIV/AIDS, and emerging infectious diseases. Our scientists conduct basic, translational, and applied research; create new technologies; and collaborate with government, industry, and academic colleagues. We support the National Cancer Institute, National Institute of Allergy and Infectious Diseases, and other institutes within the National Institutes of Health. Visit frederick.cancer.gov to learn more.

About MDIC (Medical Device Innovation Consortium)

At MDIC, we work together to innovate for better health, transforming lives by accelerating access to medical devices. MDIC advances the scientific and technical disciplines that are fundamental to medical technology throughout the total product life cycle. Founded in 2012, MDIC is the premier public-private partnership convening medical device manufacturers, researchers, regulators, payers, patients, and health care providers as trusted collaborators to solve the industry’s complex challenges. MDIC drives advancements in medical technology development, approval, coverage, adoption, and patient access in the core areas of quality design & manufacturing, evidence generation, digital health, and patient engagement. Learn more about our work at  MDIC.org.