New somatic cancer reference standards developed by Revvity in collaboration with the Medical Device Innovation Consortium (MDIC) and the National Institute of Standards and Technology (NIST) may give oncology diagnostics laboratories stronger tools for measuring and maintaining assay accuracy. The organizations announced the launch of these somatic cancer reference standards as part of MDIC’s Somatic Reference Samples (SRS) Initiative, a public-private effort to develop high-quality materials for evaluating NGS-based diagnostics. Because many cancer laboratories rely on next-generation sequencing for mutation detection, workflow validation, and proficiency testing, standardized materials with clinically relevant variants offer operational value.
MDIC and NIST collaboration focuses on real-world diagnostic needs
The SRS Initiative is designed to support diagnostic quality by producing scientifically rigorous reference materials aligned with clinical practice. The new Mimix Geni reference standards were engineered from a Genome-in-a-Bottle (GIAB) cell line and include seven oncogenic mutations selected for their clinical importance. Representatives from federal agencies, including NIH, CDC, and FDA, participated in the mutation-selection process to ensure relevance across diverse testing contexts.
The materials underwent extensive characterization by MDIC and NIST, with additional validation planned across multiple laboratories. These evaluations help confirm that the mutations behave consistently across various NGS platforms—an essential requirement for labs that rely on precision performance metrics such as sensitivity, specificity, and reproducibility.
Technical features of the Mimix Geni standards
The reference standards include engineered variants that mimic real tumor biology while maintaining a high degree of analytical traceability. They build on the well-established GIAB cell line, which has been widely used as a benchmarking tool in genomics research and in the development of clinical assays.
Key attributes include:
- Seven clinically significant oncogenic mutations incorporated at defined allele frequencies
- Cross-platform compatibility to support different sequencing chemistries and bioinformatics pipelines
- Thorough characterization performed by NIST and MDIC
- Planned interlaboratory studies to gather additional performance data
These traits enable labs to incorporate the new materials into routine quality control activities, method validation studies, assay comparison workflows, and troubleshooting protocols.
“Through this collaboration, we’ve created novel reference standards that oncology diagnostics labs can really trust as a robust foundation for monitoring assay sensitivity, specificity, and reproducibility,” said Bryan Kipp, senior vice president of technology and licensing at Revvity. He added that reliable materials with clinically relevant mutations help labs deliver “more timely, precise and accurate results for cancer patients.”
Maryellen de Mars, head of the Center for Manufacturing Innovation and Quality at MDIC, noted that the project reflects MDIC’s commitment to collaborative innovation. “By convening experts across government, industry, and academia, MDIC ensures that the tools developed are not only scientifically rigorous but also aligned with real-world clinical needs—ultimately improving patient outcomes,” she said.
How somatic cancer reference standards may help lab managers
For laboratory leaders overseeing molecular diagnostics programs, the new somatic cancer reference standards may serve as a practical resource for strengthening assay reliability. These materials support consistent benchmarking, help identify assay drift, and provide a more controlled foundation for validating new workflows.
They may also reduce the operational risk associated with platform variation, reagent lot changes, or updates to bioinformatics pipelines—common issues that can affect variant calling performance in NGS workflows. Labs preparing for accreditation audits or implementing new quality-management requirements can use these standards as documented evidence of assay performance monitoring.
Revvity will showcase the Mimix Geni standards and additional products at the AMP annual meeting in Boston later this month.
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This article was created with the assistance of Generative AI and has undergone editorial review before publishing.
