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Early detection of colorectal cancer mutations from tissue samples

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 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 TypeFFPE Tissues from Colorectal Cancer
Pack Size3 Samples; 21 Samples
Validated InstrumentsRoche LC 96, LC 480 II, and Bio-Rad CFX384
Detection ChannelFAM; HEX
Turnaround TimeLess than 3 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

COMPREHENSIVE

20 proprietary DNA markers from 4 genes

RAPID

Less than 3 hours of assay run time

SENSITIVE

Highly sensitive detection utilizing XNA-based clamping technology

CLINICAL SENSITIVITY

Increase probability of detection with at least one gene likely to be positive in >60% of advanced adenomas and >90% of colorectal cancer

COMPATIBLE

Ready to run on most qPCR machines

CE/IVD CLEARED

ColoScape™ test is CE/IVD cleared

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.