ColoScape™ Colorectal Cancer Mutation Detection Kit
ColoScape™ is a highly sensitive real-time PCR-based in vitro diagnostic assay for qualitative detection of colorectal cancer associated biomarkers in liquid biopsy and FFPE tissue samples. The kit utilizes DiaCarta’s proprietary QClamp® TaqMan-based PCR technology which leverages a sequence-speciﬁc clamp made by xeno-nucleic acid (XNA) to suppress PCR ampliﬁcation of wild-type DNA template and selectively amplify only mutant DNA template. The detection kit identiﬁes the presence or absence of mutations in the targeted regions. This technology enables a rapid, reproducible and aﬀordable solution which employs a simple workﬂow and PCR machines that are commonly used in research labs.
|Specification||ColoScape™ Colorectal Cancer Mutation Detection Kit|
|Intended Use||For In Vitro Diagnostic Use (CE/IVD) or For Research Use|
|Sample Type||Plasma, FFPE, Blood (cell-free DNA), FFPE Tissue|
|Pack Size||3 Samples, 21 Samples|
|Instruments Validated||Roche LC 96, LC 480 II, Bio-Rad CFX384 and ABI QuantStudio 5|
|Detection Channel||FAM; HEX|
|Turnaround Time||Less than 4 hours|
|Stability||Stable for 12 months at -25 ℃ to -15 ℃|
|Product Name||Catalog # (RUO)||Catalog # (CE/IVD)|
|ColoScape™ Colorectal Cancer Mutation Detection Kit (3 Samples)||DC-30-0006R||DC-30-0006E|
|ColoScape™ Colorectal Cancer Mutation Detection Kit (21 Samples)||DC-30-0024R||DC-30-0024E|
Note: RUO (Research Use Only) products are not for use in diagnostic procedures. CE/IVD products are intended for use in diagnostic procedures.
Aids colonoscopists in the diagnosis of serrated advanced adenomas
Proprietary XNA technology accurately identifies wild-type and mutant status of relevant genes
A blood test intended to diagnose colorectal cancer recurrence at the earliest, most treatable stages
Patented gene panel covering 4 genes and 21 mutations
Detects reliably below 1% mutant DNA by real-time PCR
>60% of advanced adenomas in tissue and >90% of colorectal cancer
Less than 4 hours of assay run time
Works with most common PCR machines
qPCR amplification curves generated by ColoScape™ on FFPE tissue.
ColoScape™ performance from FFPE samples. Pre-cancer detection sensitivity is 60% (6 out of 10 samples). Data from internal studies at DiaCarta.
Comparing the technical details and performance characteristics of ColoScape™ (DiaCarta) and Cologuard® (Exact Sciences). ColoScape™ data from an independent study performed by the University of Potsdam.