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Revvity Collaborates with MDIC and NIST to Launch New Somatic Cancer Reference Standards to Monitor Diagnostic Assay Accuracy

via Business Wire

 

Revvity, Inc., today announced the launch of new highly-characterized somatic cancer reference standards developed in collaboration with the Medical Device Innovation Consortium (MDIC) and the National Institute of Standards and Technology (NIST) as part of the Somatic Reference Samples (SRS) Initiative.

The Somatic Reference Samples (SRS) Initiative is a public-private partnership convened and led by MDIC to guide the development of reference samples that can be used to develop and validate NGS-based cancer diagnostics.

The new MimixTM GeniTM reference standards were developed from the extensively tested Genome-in-a-Bottle Consortium (GIAB) cell line and engineered by Revvity to contain seven oncogenic mutations. Each mutation was carefully selected for its clinical significance by industry experts, including representatives from NIST, the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), and U.S. Food and Drug Administration (FDA). The reference standards have undergone extensive testing and validation by MDIC and NIST, with further validation by multiple labs planned soon.

"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, 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, which can provide a foundation for personalized treatment based on an individual’s specific cancer.”

“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.”

Revvity will showcase its new Mimix Geni reference standards, along with other innovations, at the AMP annual meeting, November 11-15 in Boston, Massachusetts. For more information about Mimix Geni reference standards, visit our website.

About Revvity

At Revvity, “impossible” is inspiration, and “can’t be done” is a call to action. Revvity provides health science solutions, technologies, expertise and services that deliver complete workflows from discovery to development, and diagnosis to cure. Revvity is revolutionizing what’s possible in healthcare, with specialized focus areas in translational multi-omics technologies, biomarker identification, imaging, prediction, screening, detection and diagnosis, informatics and more.

With 2024 revenue of more than $2.7 billion and approximately 11,000 employees, Revvity serves customers across pharmaceutical and biotech, diagnostic labs, academia and governments. It is part of the S&P 500 index and has customers in more than 160 countries.

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About MDIC (Medical Device Innovation Consortium)

At MDIC, we unite in a shared mission to improve health and save lives by accelerating access to medical technologies. Through stakeholder collaboration, MDIC leads the way in advancing the scientific and technical foundations of medical device design, manufacturing, regulation, reimbursement and clinical integration. Founded in 2012 as a nonprofit, public-private partnership to elevate regulatory science, MDIC develops new approaches and tools for addressing shared challenges among medical device manufacturers, researchers, regulators, payers, patients, and health care providers. We deliver high impact work in the core areas of quality design and manufacturing, evidence generation, digital technology and transformation, and patient engagement. To learn more and join us in our mission, visit MDIC.org.

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