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- Mimix™ Oncospan™, FFPE Reference Standard IVD
Mimix™ Oncospan™, FFPE Reference Standard IVD
Mimix™ OncoSpan™ FFPE reference standards are a commutable control material consisting of a blend of human cancer cell lines that have been fixed in formalin and embedded in paraffin blocks. Mimix OncoSpan controls are a thoroughly characterized, cell line-derived reference standard, featuring 386 variants across 152 essential 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 a well-characterized, cell line-derived pan-cancer reference standard, featuring over 380 variants across 152 key cancer genes. These variants range from 0.9% -100% allelic frequency (AF), with 60 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 or Aviti 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: FFPE
Fixation method: 4% PFA (w/v)
Section size: 15µm
Cell density 3 x 108 cells per block. Approx. 3.5 x 105 cells per section
Expected DNA yield: > 400 ng using Promega Maxwell RSC FFPE Plus DNA Extraction kit
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: 0.9% - 92.5% for ddPCR-verified variants
Chromosome |
Gene |
Variant |
Expected Allelic Frequency % |
---|---|---|---|
chr2 (29416025) |
ALK |
N/A (Ins) |
10.0% |
chr5 (112175770) |
APC |
p.T1493T |
35.0% |
chr7 (140453136) |
BRAF |
p.V600E |
10.7% |
chr13 (32913558) |
BRCA2 |
p.K1691fs*15 |
32.5% |
chr3 (41266101) |
CTNNB1 |
p.S33Y |
32.5% |
chr3 (41266133) |
CTNNB1 |
p.S45del |
10.0% |
chr7 (55241707) |
EGFR |
p.G719S |
24.5% |
chr7 (55249071) |
EGFR |
p.T790M |
0.90% |
chr7 (55259515) |
EGFR |
p.L858R |
2.80% |
chr7 (55242464) |
EGFR |
p.E746_A750 delELREA |
1.90% |
chr7 (55249063) |
EGFR |
p.Q787Q |
15.0% |
chr4 (153244155) |
FBXW7 |
p.S668fs*39 |
32.5% |
chr13 (28578214) |
FLT3 |
p.P986fs*>8 |
10.0% |
chr4 (55599321) |
KIT |
p.D816V |
10.0% |
chr4 (55602765) |
KIT |
p.L862L |
7.5% |
chr12 (25398281) |
KRAS |
p.G13D |
15.0% |
chr12 (25398284) |
KRAS |
p.G12D |
6.30% |
chr7 (116436022) |
MET |
p.A1357A |
7.0% |
chr7 (116339847) |
MET |
p.L238fs*25 |
7.0% |
chr9 (139409754) |
NOTCh1 |
p.P668S |
30.0% |
chr1 (115256530) |
NRAS |
p.Q61K |
12.5% |
chr3 (178936091) |
PIK3CA |
p.E545K |
8.80% |
chr3 (178952085) |
PIK3CA |
p.H1047R |
17.5% |
chr10 (43613843) |
RET |
p.L769L |
60.0% |
chr17 (7579472) |
TP53 |
p.P72R |
92.5% |
General information
Storage: 4°C
Shipping: Ambient
Expiration: See all product shelf life information
Intended Use Statement:
The Mimix™ OncoSpan™ FFPE reference standard is a commutable control material comprising a formalin-fixed paraffin-embedded (FFPE) curl derived from well characterized human cancer cell lines, containing more than 380 variants across 152 key cancer genes. It is intended for monitoring next-generation sequencing (NGS) or droplet digital polymerase chain reaction (ddPCR) assays designed to assist in the detection of somatic mutations in genomic DNA (gDNA) from human samples for in vitro diagnostic use.
The gDNA obtained from the Mimix OncoSpan FFPE Reference Standard can be used to monitor NGS or ddPCR workflow, test performance, assay variation and helps identify increases in random or systematic errors. This product is for professional laboratory use only.
Intended Use: For In Vitro Diagnostic Use Only.
Quality control
Allelic frequency: Droplet Digital™ PCR or NGS
Quantification: Quantifluor
DNA Integrity: Agarose gel electrophoresis
Manufacturing Quality: ISO13485
Mimix OncoSpan publications
Read these research articles citing the use of Mimix OncoSpan reference standards.
- Validation of a pan-cancer targeted next generation sequencing panel in New Zealand | New Zealand Journal of Medical Laboratory Science
- Enabling variant calling in challenging FFPE samples by coupling a novel library preparation chemistry with exome sequencing | Journal of Clinical Oncology
- Moving towards a local testing solution for undetermined thyroid fine-needle aspirates: validation of a novel custom DNA-based NGS panel | Journal of Clinical Pathology
- Performance Analysis of Three Bioinformatic Variant Callers Using a Somatic Reference Standard | Children's Mercy Kansas City
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