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Liquid Biopsy & FFPE

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.

Product specifications

Specification ColoScape™ Colorectal Cancer Mutation Detection Kit
Intended UseFor In Vitro Diagnostic Use (CE/IVD) or For Research Use
Sample TypePlasma, FFPE, Blood (cell-free DNA), FFPE Tissue
Input DNA5-10ng/reaction
Pack Size3 Samples, 21 Samples
Instruments Validated Roche LC 96, LC 480 II, Bio-Rad CFX384 and ABI QuantStudio 5
Detection ChannelFAM; HEX
Detection Chemistry TaqMan
Turnaround TimeLess than 4 hours
StabilityStable for 12 months at -25 ℃ to -15 ℃

Ordering information

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.

Features and benefits

DIAGNOSTIC AID

Aids colonoscopists in the diagnosis of serrated advanced adenomas

THERAPY RESPONSE

Proprietary XNA technology accurately identifies wild-type and mutant status of relevant genes

NON-INVASIVE TESTING

A blood test intended to diagnose colorectal cancer recurrence at the earliest, most treatable stages

COMPREHENSIVE

Patented gene panel covering 4 genes and 21 mutations

ULTRA-SENSITIVE

Detects reliably below 1% mutant DNA by real-time PCR

CLINICAL SENSITIVITY

>60% of advanced adenomas in tissue and >90% of colorectal cancer

RAPID

Less than 4 hours of assay run time

VERSATILE

Works with most common PCR machines

Supporting data

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.