Precision approaches to disease diagnostics and treatment as well as innovations in nucleic acid quantitation have enabled the creation of better tools for assay development. Accordingly, ATCC has developed purified and quantitative cell line genomic DNA (qDNA) with known mutation allelic frequency and gene copy number, which can provide a reliable and more sustainable alternative to patient tissue-derived controls for oncology molecular diagnostic assays. These whole-genome preparations save you the time and cost associated with culturing the cells as well as extracting and quantitating the nucleic acids yourself.

ATCC qDNA are extracted from patient samples or cell lines that contain biomarkers that have been quantified by validated methods for each product lot. Because qDNA are fully quantified by NGS and droplet digital PCR (ddPCR™; BioRad), they are compatible with several lab-developed and commercially available assays as BSL-1, ready-to-use controls for your assays. They can be used for the generation of a standard curve, as positive controls for molecular-based assay development, as independent standards for validation and verification, and for monitoring assay-to-assay and lot-to-lot variation.

Specification and characteristics for each lot of qDNA includes:

• ddPCR™ quantitated for high-precision analysis 
• Next-generation sequenced
• Well-characterized genetic alterations
• Absolute mutation/amplification copy number
• Agarose gel electrophoresis to ensure integrity
• Spectrophotometry to evaluate purity
• PCR to confirm functional activity
• STR profiling to ensure identity

Further, each of our products is manufactured under ISO 9001 certified and ISO/IEC 17025 accredited processes, so you can trust your results and reproduce your data—every time.