Revvity, Inc. has introduced a set of highly characterized somatic cancer reference standards created in partnership with the Medical Device Innovation Consortium (MDIC) and the National Institute of Standards and Technology (NIST) under the Somatic Reference Samples Initiative. The initiative, led by MDIC as a public-private collaboration, aims to establish reference materials that can be used to develop and validate next-generation sequencing cancer diagnostics.
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The newly developed MimixTM GeniTM reference standards are derived from the well-studied Genome-in-a-Bottle Consortium cell line and engineered by Revvity to carry seven clinically relevant oncogenic mutations. These mutations were carefully chosen for their significance in patient care by a team of experts including representatives from NIST, the National Institutes of Health, the Centers for Disease Control and Prevention, and the U.S. Food and Drug Administration. Extensive validation of these standards has been performed by MDIC and NIST, with additional testing across multiple laboratories planned in the near future.
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Bryan Kipp, senior vice president of technology and licensing at Revvity, emphasized the importance of the new standards, stating that they provide oncology diagnostic laboratories with a dependable foundation to measure assay sensitivity, specificity, and reproducibility. He noted that access to reliable reference standards containing clinically relevant mutations enables diagnostic teams to deliver faster and more precise results, which supports the personalization of treatment for individual cancer patients.
Maryellen de Mars, head of the Center for Manufacturing Innovation and Quality at MDIC, highlighted the initiative as an example of MDIC’s dedication to improving diagnostic accuracy and patient care through collaborative innovation. She explained that the new reference standards set a higher benchmark for quality and consistency in cancer testing, ensuring that tools developed are scientifically rigorous and aligned with the practical needs of clinical laboratories.
The collaboration between Revvity, MDIC, and NIST demonstrates a strong commitment to advancing oncology diagnostics by combining expertise from government, industry, and academic institutions. These reference standards are expected to help labs monitor and improve the accuracy of cancer assays, ultimately contributing to better patient outcomes and more informed treatment decisions.
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