Setting a New Benchmark for Oncology NGS Validation
Developed through a multi-year public-private collaboration led by the Medical Device Innovation Consortium (MDIC), the National Institute of Standards and Technology (NIST), and Revvity, the Mimix™ Geni™ somatic cancer reference standards provide clinical laboratories and test developers with the most rigorously characterized materials available for validating next-generation sequencing (NGS) oncology assays.
Built from an extensively characterized Genome-in-a-Bottle (GIAB) cell line and engineered to contain clinically relevant cancer mutations prioritized by an expert steering committee, these reference standards help ensure accuracy, consistency, and confidence in cancer molecular diagnostics.
Advancing Reliable Oncology NGS Through Public–Private Collaboration
The Mimix™ Geni™ Somatic Cancer Reference Standards mark a major advancement in the availability of rigorously characterized materials to support oncology next-generation sequencing (NGS). Through MDIC’s Somatic Reference Samples (SRS) Initiative, and in partnership with NIST and Revvity, this effort addresses a long-recognized need for trusted reference materials that improve consistency, accuracy, and confidence in cancer molecular diagnostics. These new resources reflect MDIC’s commitment to regulatory science solutions that directly support patient care and enable high-quality, evidence-based innovation.
A Foundation Built on Scientific Rigor
Developed from a Genome-in-a-Bottle (GIAB) Consortium cell line and engineered to contain seven clinically relevant cancer mutations identified by an expert steering committee, the Mimix Geni standards leverage more than a decade of foundational genomic characterization. MDIC and NIST conducted extensive analytical and interlaboratory testing to ensure these reference materials perform reliably across platforms, workflows, and testing environments. This rigorous approach ensures that laboratories and manufacturers have access to validated tools capable of supporting robust assay performance.
Strengthening Confidence in Precision Oncology Tools
These reference standards are designed to help clinical diagnostic laboratories, test developers, and medical device manufacturers evaluate key dimensions of assay performance. As precision oncology continues to evolve, consistent benchmarks are essential for ensuring that patients receive high-quality, actionable results. The Mimix Geni standards contribute directly to this goal by offering a deeply characterized, oncology-specific resource that supports continuous innovation and regulatory confidence.
Key Features and Advantages
- Developed through MDIC’s Somatic Reference Samples (SRS) Initiative in collaboration with NIST
- Built from a GIAB Consortium cell line (GM24385) with extensive genomic characterization
- Engineered by Revvity to include seven clinically relevant cancer mutations selected by an expert committee
- Rigorously tested and validated through MDIC- and NIST-led interlaboratory studies
- Includes both DNA and RNA analytes to support multi-modal oncology assay evaluation
- Enables assessment of sensitivity, specificity, reproducibility, and overall assay performance
- Supports assay development, validation, and quality assurance across diverse NGS platforms