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Cell line-derived controls for patient-like performance

Developing cancer assays requires reference standards that deliver consistent, patient-like performance. With Mimix™ reference standards, you get the reliability in a true genomically complex background that assay developers need to verify assay performance and robustness.

Mimix control advantages at a glance:

Manufactured under ISO 13485:2016
Rigorously QC tested for batch-to-batch consistency
Cell line-derived to maintain genomic complexity and for patient-like performance
Renewable source for continuous availability
Shelf life up to 60 months at standard refrigeration temperatures
Options for controls made to meet your specific needs

Characterized cell lines containing specific variants are blended to create standards with a few or multiple variants of known allelic frequencies. The blended cell mixture is then subjected to quality control analysis and processed to be available in a variety of formats.

Optimize sensitivity and specificity with confidence

Balancing high sensitivity with specificity to avoid false positives is one of assay development's greatest challenges. Reliable control materials help by providing defined allele frequencies, enabling LoD determination, and supporting verification of performance.

Mimix controls deliver:

Commutable, cell line-derived standards that closely mimic patient sample complexity and genomic characteristics.
Defined allele frequencies for precise limit of detection (LoD) determination - you can test down to 1% VAF or as low as 0.1% with our made-to-order controls with reproducible performance for dilution studies.
Comprehensive variant coverage including SNVs, CNVs, indels, and fusions across multiple cancer-associated genes.
Matched pair controls to support reliable assay validation and cut-off determination.
Made-to-order controls by selecting any combination of variants, allele frequencies, and formats from our off-the-shelf catalog.
Custom options for reference materials with requirements not available for our catalog products, such as methylation and enzymatic fragmentation.

Monitor assay robustness across your workflow

Quality reference standards play a crucial role in maintaining consistency across batches, labs, operators, equipment, and sample types which is essential for assay development.

Mimix reference material offer:

Rigorous batch-to-batch testing providing consistent performance that supports reliable monitoring of assay variability.
Stable, reliable, continuous source of controls with shelf life of up to 60 months at standard refrigeration temperatures.
Multiple formats including FFPE, cfDNA, and gDNA to support different sample types and workflows.
Platform compatibility across Next Generation Sequencing, Droplet-Digital PCR, Real-Time PCR, and Sanger sequencing

Supports regulatory compliance

Navigating evolving regulations, conducting extensive validation studies, and passing audits demands quality traceable controls developed and manufactured to a high standard.

Mimix controls provide:

Documentation in accordance with ISO 13485:2016 aiding compliance and traceability.
Reproducible performance supports consistency across tests and laboratories for proficiency testing and external quality assessment programs.

Overcome the limitations of patient samples

Using patient samples as quality assay controls presents a number of challenges. They are often difficult to obtain, poorly characterized, vary in quality yielding difference results, and unavailable in sufficient quantities for comprehensive studies.

Mimix reference standards deliver:

Continuously available source for long-term supply for development, verification, and ongoing quality control.
Degraded controls (moderate and severe) as off-the-shelf or made-to-order standards to test assay performance of challenging samples.
Cell line-derived standards that mimic patient sample genomic complexity.