Revvity Launches Next-Generation Somatic Cancer Reference Standards in Collaboration with MDIC and NIST
Revvity, Inc. today announced the release of its new, highly characterized Mimix™ Geni™ somatic cancer reference standards, developed in collaboration with the Medical Device Innovation Consortium (MDIC) and the National Institute of Standards and Technology (NIST). This launch marks a significant milestone in advancing the quality and reliability of next-generation sequencing (NGS)-based cancer diagnostics. The new standards are part of the Somatic Reference Samples (SRS) Initiative, a groundbreaking public-private partnership designed to improve the reproducibility and accuracy of molecular cancer testing.
A Milestone in Precision Oncology
The Somatic Reference Samples (SRS) Initiative, convened and led by MDIC, was established to address a long-standing challenge in oncology diagnostics: the lack of universally accepted, well-characterized reference materials for somatic mutations. As NGS-based assays become increasingly critical to identifying genetic variants that drive tumor growth, the demand for reliable, standardized reference materials has grown.
The initiative brings together leaders from government agencies, academia, and industry—including the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), the U.S. Food and Drug Administration (FDA), and NIST—to develop reference samples that can serve as benchmarks for NGS technologies. These samples allow laboratories to validate their workflows, monitor performance over time, and ensure that test results are both accurate and clinically meaningful.
By combining MDIC’s expertise in collaborative innovation with Revvity’s engineering capabilities, the project aims to set new standards for the reliability of cancer diagnostic assays used in both research and clinical settings.
The Science Behind Mimix™ Geni™
The newly launched Mimix™ Geni™ somatic cancer reference standards are based on the Genome-in-a-Bottle (GIAB) Consortium cell line, one of the most extensively studied and characterized genomic resources available today. The GIAB reference materials have served as the gold standard for benchmarking sequencing performance, providing a foundation for consistent, high-quality genomic data.
Revvity scientists have engineered these cell lines to include seven clinically significant oncogenic mutations, each chosen through a rigorous selection process by an expert panel comprising representatives from NIST, NIH, CDC, FDA, and leading industry partners. The mutations represent a spectrum of cancer-relevant genetic changes, encompassing different variant types, allele frequencies, and genomic contexts to ensure comprehensive utility across multiple testing platforms.
These mutations were selected for their clinical relevance—meaning they are known to play roles in the development or progression of various cancers and are often used to guide targeted treatment decisions. By embedding these well-characterized variants within a robust and traceable cell line, Revvity has created a standard that enables laboratories to accurately assess assay sensitivity, specificity, and reproducibility under real-world conditions.
Collaboration for Quality and Trust
The collaboration between Revvity, MDIC, and NIST represents a model of how cross-sector partnerships can accelerate progress in diagnostic science. Each organization brought unique strengths to the project.
- Revvity contributed its technical expertise in molecular engineering and its established track record in producing quality control materials for genomic testing.
- NIST provided scientific oversight and validation frameworks, ensuring that the standards meet rigorous analytical performance metrics and align with national measurement standards.
- MDIC, acting as the convener, coordinated input across government, academic, and private sector stakeholders, ensuring that the developed materials address both regulatory expectations and clinical laboratory needs.
The Mimix Geni reference standards have undergone extensive validation and performance testing by both MDIC and NIST to ensure reliability and consistency. Additional validation studies are planned across multiple independent laboratories to further confirm their robustness across diverse assay types and sequencing technologies.
Building Confidence in Cancer Diagnostics
For clinical laboratories, access to validated reference standards is essential to maintaining accuracy in cancer diagnostics. As sequencing technologies evolve and new variants are discovered, diagnostic labs must continually verify that their methods can detect mutations with high precision and sensitivity.
“Through this collaboration, we’ve created novel reference standards that oncology diagnostics labs can truly trust as a robust foundation for monitoring assay sensitivity, specificity, and reproducibility,” said Bryan Kipp, Senior Vice President of Technology and Licensing at Revvity. “Reliable reference standards with clinically relevant mutations support diagnostic labs in delivering more timely, precise, and accurate results for cancer patients. This, in turn, can provide the foundation for truly personalized treatment strategies based on an individual’s unique cancer profile.”
In an era where precision oncology is transforming patient care, these standards provide laboratories with a toolset to ensure confidence in test results. Whether used in assay development, proficiency testing, or routine quality assurance, the Mimix Geni reference standards allow scientists to measure performance and identify potential sources of variability before results reach clinicians and patients.
A Shared Vision for Innovation and Patient Impact
The Medical Device Innovation Consortium (MDIC) plays a vital role in bridging the gap between scientific research and practical clinical application. Its mission is to accelerate the development and regulatory approval of medical devices and diagnostics through collaboration and data-driven solutions.
“This project exemplifies MDIC’s commitment to advancing diagnostic quality and patient care through collaborative innovation,” said Maryellen de Mars, Head of the Center for Manufacturing Innovation and Quality at MDIC. “These reference standards reflect our commitment to setting a new benchmark for quality and consistency in cancer diagnostics. 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.”
De Mars emphasized that the partnership demonstrates how collective expertise can deliver tangible benefits for both laboratories and patients. “When diverse stakeholders work together, we can move beyond incremental progress to achieve breakthroughs that elevate the entire field of diagnostics,” she added.
Setting a New Standard for the Future
Revvity’s introduction of the Mimix Geni reference standards signals a step forward for laboratories striving to meet increasing regulatory and clinical demands for accuracy in genomic testing. These reference materials are expected to play a central role in enhancing confidence in cancer assays used for detecting actionable mutations, selecting targeted therapies, and monitoring disease progression.
Moreover, the collaboration with MDIC and NIST ensures that the standards are not only scientifically sound but also broadly applicable across platforms. This level of interoperability will help harmonize testing practices across institutions and promote greater consistency in cancer diagnostics globally.
Revvity’s Mimix Geni line will also serve as a foundation for future developments. The company plans to expand the series to include additional mutation types, variant frequencies, and cancer-specific panels, reflecting the growing complexity and diversity of somatic alterations encountered in clinical oncology.
As genomic medicine continues to reshape cancer care, the need for trustworthy reference materials becomes even more critical. Laboratories face increasing pressure to deliver fast, reproducible, and accurate genomic results that directly influence clinical decision-making. Initiatives like the SRS project—and products like the Mimix Geni reference standards—help laboratories meet these challenges head-on.
By anchoring diagnostic testing in standardized, well-characterized materials, the broader oncology ecosystem gains a common framework for quality assurance and performance measurement. Ultimately, this leads to better test reliability, improved clinical confidence, and, most importantly, better outcomes for patients.
Revvity’s launch exemplifies how collaborative innovation can drive meaningful progress in precision diagnostics. The partnership’s success underscores the importance of combining government oversight, industrial capability, and scientific rigor to ensure that the next generation of cancer tests is both powerful and trustworthy.
Showcasing Innovation
Revvity will showcase its new Mimix™ Geni™ reference standards—alongside other advances in molecular diagnostics—at the Association for Molecular Pathology (AMP) Annual Meeting, taking place November 11–15 in Boston, Massachusetts. Conference attendees will have the opportunity to explore how these standards can support assay development, performance benchmarking, and regulatory compliance.
For additional information on the Mimix Geni reference standards, visit Revvity’s website or contact the company’s diagnostics division for technical specifications and ordering details.
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