Revvity has launched new, highly-characterized Somatic Cancer Reference standards to boost precision in oncology diagnostics. These standards were 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 new products, part of the Mimix Geni line, are designed to help laboratories monitor the accuracy, sensitivity, and reproducibility of their diagnostic assays, especially those using next-generation sequencing (NGS) and droplet digital PCR (ddPCR).

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.”