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- Mimix™ OncoSpan™, gDNA Reference Standard IVD
Mimix™ OncoSpan™, gDNA Reference Standard IVD
Mimix™ OncoSpan™ gDNA reference standard is a commutable genomic DNA control material, consisting of extracted genomic DNA from a blend of human cancer cell lines. Mimix OncoSpan controls are well-characterized, cell line-derived reference standards, containing 386 variants across 152 key cancer genes.
For In Vitro Diagnostic use. This product is only available where licensed in accordance with law. Please contact your local representative for availability.
Mimix OncoSpan controls are well-defined reference standards derived from a blend of cell lines, encompassing 386 variants across 152 essential cancer genes. These variants range from 1-100% allelic frequency (AF), with 51 variants present at ≤ 20% AF to aid in the limit of detection (LOD) determination of your assay. Each batch of Mimix OncoSpan controls include 25 variants confirmed by ddPCR, along with batch-specific whole exome sequencing (WES) at 500x coverage performed by Revvity Omics using the Agilent CREV3 kit on an Illumina platform. This helps to provide an accurate and reliable truth set for monitoring your workflow and assay's performance.
Upon ordering, you will receive a password to download the raw NGS data for your batch (including bam, bed, and vcf files). For added convenience, we also provide an easy-to-access Excel document listing the 386 high-confidence variants, available for download. 386 high confidence variants in an easy-to-access excel document.
Technical Product Information
Format: gDNA
Genes covered: ABL1, AKT1, AKT2, ALK, APC, AR, ARID1A, ATR, ATRX, AXL, BARD1, BCL6, BLM, BMPR1A, BRAF, BRCA1, BRCA2, BTK, BUB1B, CARD11, CCND1, CCND3, CCNE1, CD79B, CDh2, CDK12, CDK4, CEP57, CFH, CREBBP, CSF1R, CTNNB1, DDR2, DIS3L2, DNMT3A, EGFR, EML4, EP300, EPCAM, ERBB2, ERBB3, ERCC1, ERCC2, ERCC4, ERCC5, ERG, ETS1, ETV4, EWSR1, EXT1, FANCA, FANCD2, FANCE, FANCG, FANCI, FANCM, FBXW7, FGF10, FGF2, FGF3, FGF6, FGFR1, FGFR3, FLCN, FLI1, FLT1, FLT3, FZR1, GATA2, GATA3, GEN1, GNA11, GNAS, HNF1A, HRAS, IDh2, IDh4, JAK1, JAK2, JAK3, KDR, KIT, KRAS, LDLR, MAGI1, MAP2K1, MAP2K2, MAX, MDM4, MED12, MET, MLh2, MLLT3, MMAB, MRE11, MSh4, MSH6, MTOR, NBN, NF1, NFE2L2, NOTCh1, NOTCh4, NOTCh6, NRAS, NRG1, NTRK1, NTRK3, PDGFRA, PDGFRB, PIK3CA, PIK3CD, PIK3CG, PIK3R1, PMS2, PPARG, PPP2R2A, PRKAR1A, PROC, PTCh2, PTPN11, RAD51B, RAD54L, RAF1, RB1, RBM45, RECQL4, RET, RHBDF2, ROS1, RPS6KB1, SDHB, SF3B1, SF3B2, SLTM, SLX4, SMARCB1, SMO, SMOX, STK11, TERT, TET2, TFRC, TP53, TP53BP1, TSC1, TSC2, WRN, XPA, XPC, ZNF395
Allelic frequencies: 1% - 92.5% for ddPCR-verified variants
Chromosome | Gene | Variant | Expected Allelic Frequency % |
---|---|---|---|
chr2 (29416025) | ALK | N/A (Ins) | 10.00% |
chr5 (112175770) | APC | p.T1493T | 35.00% |
chr7 (140453136) | BRAF | p.V600E | 10.50% |
chr13 (32913558) | BRCA2 | p.K1691fs*15 | 32.50% |
chr3 (41266101) | CTNNB1 | p.S33Y | 32.50% |
chr3 (41266133) | CTNNB1 | p.S45del | 10.00% |
chr7 (55241707) | EGFR | p.G719S | 24.50% |
chr7 (55249071) | EGFR | p.T790M | 1.00% |
chr7 (55259515) | EGFR | p.L858R | 3.00% |
chr7 (55242464) | EGFR | p.E746_A750 delELREA | 2.00% |
chr7 (55249063) | EGFR | p.Q787Q | 15.00% |
chr4 (153244155) | FBXW7 | p.S668fs*39 | 32.50% |
chr13 (28578214) | FLT3 | p.P986fs*>8 | 10.00% |
chr4 (55599321) | KIT | p.D816V | 10.00% |
chr4 (55602765) | KIT | p.L862L | 7.50% |
chr12 (25398281) | KRAS | p.G13D | 15.00% |
chr12 (25398284) | KRAS | p.G12D | 6.00% |
chr7 (116436022) | MET | p.A1357A | 7.00% |
chr7 (116339847) | MET | p.L238fs*25 | 7.00% |
chr9 (139409754) | NOTCh1 | p.P668S | 30.00% |
chr1 (115256530) | NRAS | p.Q61K | 12.50% |
chr3 (178936091) | PIK3CA | p.E545K | 9.00% |
chr3 (178952085) | PIK3CA | p.H1047R | 17.50% |
chr10 (43613843) | RET | p.L769L | 60.00% |
chr17 (7579472) | TP53 | p.P72R | 92.50% |
Buffer: Tris-EDTA (10mM Tris-HCl, 1mM EDTA), pH 8.7
Unit size: 1μg
Concentration: 50ng/μl
General information
Storage: 4°C
Shipping: Ambient
Expiration: See all product shelf life information
Intended Use:
The Mimix™ OncoSpan™ gDNA reference standard is a commutable control material comprising a mixture of genomic DNA (gDNA) derived from well characterized human cancer cell lines, containing more than 380 variants across 152 key cancer gene. It is intended for monitoring next-generation sequencing (NGS) and droplet digital polymerase chain reaction (ddPCR) assays designed to assist in the detection of somatic mutations in human gDNA samples for in vitro diagnostic use.
This control can be used to monitor NGS and ddPCR workflow, test performance, assay variation and helps identify increases in random or systematic errors. This product is for professional laboratory use only.
Quality control
Allelic frequency: Droplet Digital™ PCR or NGS
Quantification: Spectrophotometer
DNA Integrity: Agarose gel electrophoresis
Manufacturing Quality: ISO 13485:2016
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