The standards developed through a public-private partnership contain seven oncogenic mutations selected for clinical significance.
Revvity Inc has launched 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 Initiative.
The new Mimix Geni reference standards were developed from the Genome-in-a-Bottle Consortium cell line and engineered to contain seven oncogenic mutations. Each mutation was selected for its clinical significance by industry experts, including representatives from NIST, the National Institutes of Health, the Centers for Disease Control and Prevention, and the Food and Drug Administration.
The Somatic Reference Samples 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 next-generation sequencing-based cancer diagnostics.
“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,” says Bryan Kipp, senior vice president, technology and licensing at Revvity, in a release. “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.”
Extensive Testing and Validation
The reference standards have undergone extensive testing and validation by MDIC and NIST, with further validation by multiple laboratories planned, according to a release from Revvity. The standards are designed to help oncology diagnostic laboratories monitor the accuracy of their NGS-based assays.
“This project exemplifies MDIC’s commitment to advancing diagnostic quality and patient care through collaborative innovation,” says Maryellen de Mars, head of the Center for Manufacturing Innovation and Quality at MDIC, in a release. “These reference standards reflect our commitment to setting a new benchmark for quality and consistency in cancer diagnostics.”
De Mars notes that by convening experts across government, industry, and academia, MDIC ensures that the tools developed are scientifically sound and aligned with real-world clinical needs.
Revvity showcased the new Mimix Geni reference standards at the Association for Molecular Pathology annual meeting, held Nov 11-15 in Boston.
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