Mimix Geni Somatic Cancer Reference Standards

Highly characterized reference materials for oncology NGS validation

The Mimix™ Geni™ somatic cancer reference standards are highly characterized controls developed in collaboration with the Medical Device Innovation Consortium (MDIC) and the National Institute of Standards and Technology (NIST). They’ve been developed as part of the Somatic Reference Samples (SRS) Initiative to help clinical diagnostic labs improve the accuracy of their cancer diagnostic assays and medical device manufacturers verify their tests and platforms.

Key features

Genome-in-a-Bottle Foundation

These somatic reference standards are developed from the extensively tested and characterized Genome-in-a-Bottle Consortium (GIAB) cell line.

Expertly Engineered by Gene Editing Specialists

Revvity (then Horizon) was selected to join the SRS initiative for our gene editing and reference standard expertise as a development collaborator. Drawing from these expertise, we have successfully engineered the GIAB cell line to contain clinically-relevant cancer mutations selected by SRS steering committee experts, including representatives from NIST, NIH, CDC, and FDA.

Rigorous Validation

MDIC and NIST have rigorously tested and validated the Mimix Geni standards, with ongoing interlab validation.

Reliable Pan-Cancer Control Material

Pan-cancer control material containing DNA and RNA fusions
Generated from a GIAB Consortium cell line (GM24385)
Engineered by Revvity with cancer mutations selected by industry experts
Rigorous testing and validation by MDIC and NIST

Benefits for Oncology Diagnostic Labs

These highly characterized reference standards provide a robust foundation for assessing assay:

Sensitivity
Specificity
Reproducibility

Development Timeline: Setting the Standard in Oncology NGS Reference Materials

Take a walk with us through the timeline behind the development of the Mimix Geni somatic cancer reference standards.

		2011: Identifying the Challenge The CDC convened leading experts, including NIST, to help integrate NGS into clinical testing. A critical gap emerged: the absence of a universally accepted reference sample for validating NGS workflows.
		2012: Establishing Guidelines The Next-generation Sequencing: Standardization of Clinical Testing workgroup published foundational guidelines, laying the groundwork for reliable, clinically actionable NGS results.
		GIAB Consortium Established To address the need for gold-standard reference materials, NIST launched the Genome in a Bottle (GIAB) consortium, producing highly characterized cell lines that are now globally recognized benchmarks. However, oncology-specific reference materials remained elusive. Recognizing this gap, the MDIC partnered with NIST and convened the Somatic Reference Samples (SRS) Initiative, a public-private partnership to guide the development of reference samples that can be used to develop and validate NGS-based cancer diagnostics.
		2020: Strategic Partnership MDIC approached Revvity (then Horizon) for our gene editing and reference standard development expertise and, following our selection through an RFP process, a collaboration was formed.
		2025: Breakthrough innovation After years of co-development, we achieved a breakthrough: the first and only GIAB Consortium cell line engineered to contain seven clinically relevant oncology mutations as selected by the SRS steering committee of industry experts.
		The result Mimix Geni reference standards set a new benchmark for cancer diagnostics and NGS validation, providing the oncology community with trusted, characterized reference materials.