RealTime mS9 Colorectal Cancer
| Product Name | Quantity | Order # | Additional Information | ||
| Abbott RealTime mS9 Colorectal Cancer Amplification Reagent Kit | 32 tests |
4N48-90 |
|
||
| Abbott RealTime mS9 Colorectal Cancer Control Kit | Negative: 12 vials/ Positive: 12 vials | 4N48-80 |
|
||
| Abbott Bisulfite Modificaton Kit | 32 tests : DNA Protect Buffer: 1 vial/ Bisulfite Mix: 8 vials | 4N74-60 |
|
||
| Abbott RealTime mS9 Colorectal Cancer - m2000 System ROW Combined Application CD-ROM | 1 each | 4N48-01 |
|
||
| Abbott mSample Preparation System (DNA) | 32 tests (4 packs, 8 tests/pack) | 06K12-024 |
|
||
| Abbott m2000 Low Residual Volume Sample Rack Posts | 2 Posts per pkg | 05N22-01 |
|
||
| Abbott m2000 Low Residual Volume Tube | 10 tubes per pkg | 05N29-01 |
|
||
The Abbott RealTime mS9 Colorectal Cancer assay is an in vitro polymerase chain reaction (PCR) test for the qualitative detection of the presence of methylated Septin 9 in plasma. The Abbott RealTime mS9 Colorectal Cancer assay may be useful as an indicator of the presence of colorectal cancer when confirmed by colonoscopy.
Colorectal cancer (CRC) is the second leading cause of cancer-related death and ranks third among most prevalent cancers worldwide.1 Although CRC is a serious condition, when detected early, five year survival rate can be as high as 90%. According to established guidelines, a number of screening modalities are recommended for use in an average risk population. These include, but are not limited to, fecal occult blood test, endoscopy, stool DNA and CT colonography.2,3 However, screening compliance rates are low and CRC can progress to later stages without any evident symptoms. About 55-60% of CRC's are diagnosed at an advanced stage and stage IV CRC's have a five-year survival rate of 11%.4
The Abbott RealTime mS9 Colorectal Cancer assay monitors the presence of methylated Septin 9. Methylation of the Septin 9 promoter region, also termed epigenetic modification, has been associated with colorectal cancer. Determination of epigenetic events is a useful tool for early detection of disease since regulation of gene expression by aberrant DNA methylation is a well-characterized event in tumor biology, and is extensively described for CRC. Increased levels of cell-free circulating methylated DNA in the blood of cancer patients compared to healthy controls have been reported and can be used as a target for CRC detection.5-7
Results You Can Trust
- Internal control to monitor for inhibition and sample adequacy
- Real-Time format
Amplification Details
Product manufactured under license from Epigenomics and covered by one or more of the following patents EP1721992, US6,331,393, US7,229,759, EP1370691, and their foreign equivalents.
Reliable Results Abbott RealTime mS9 Intended Use
The Abbott RealTime mS9 Colorectal Cancer assay is an in vitro polymerase chain reaction (PCR) test for the qualitative detection of the presence of methylated Septin 9 in plasma. The Abbott RealTime mS9 Colorectal Cancer assay may be useful as an indicator of the presence of colorectal cancer when confirmed by colonoscopy
| Product Design |
|
| Instrumentation: | Extraction: m2000sp, Amplification and Detection: m2000rt |
| Kit Configuration: |
32 tests per kit (4 x 8 tests/pack) |
| Technology: |
Multiplex Heavy Methyl Real-Time PCR |
| Assay Performance: |
Sensitivity- Stage I 52%: Stage II 76%: Stage III 76%: Stage IV 100% Specificity - 99% |
| Sample Type: |
Human Plasma |
| Input Volmume: |
4.0 ml automated / 3.5 ml manual |
| Internal Control: |
An endogenous Beta-actin sequence is detected as sample validity control for DNA adequacy, sample extraction and amplification efficiency |
| External Controls: |
Negative control; Positive control |
| Reported Results: |
Qualitative detection of methylated Septin 9 - Positive or Negative |
| Dyes | Probe Labels |
Type Specific Probes |
| 3 | FAM | methylated Septin 9 |
| 4 | Quasar | Internal Control (Beta-actin) |
| 5 | ROX | Passive Reference |
Product manufactured under license from Epigenomics and covered by one or more of the following patents EP1721992, US6,331,393, US7,229,759, EP1370691, and their foreign equivalents.
The Abbott RealTime mS9 Colorectal Cancer assay is an in vitro polymerase chain reaction (PCR) test for the qualitative detection of the presence of methylated Septin 9 in plasma. The Abbott RealTime mS9 Colorectal Cancer assay may be useful as an indicator of the presence of colorectal cancer when confirmed by colonoscopy
References
- Globocan 2002 CA Cancer J Clin 2005;55;74-108
- Levin B, Lieberman DA, Beth McFarland B, et al. US Multi-Society Task Force on Colorectal Cancer, and the American College of Adenomatous Polyps, 2008: A Joint Guideline from the American Cancer Society, the Screening and Surveillance for the Early Detection of Colorectal Cancer and Radiology. CA Cancer J Clin 2008;58:130-60.
- Schmiegel W, Pox C, Reinacher-Schick A, et al. S3-Guideline "Colorectal Cancer" 2004/2008. Z Gastroenterol 2008;46:1-73.
- ACS. Colorectal Cancer Facts & Figures. 2008-2010; http://www.cancer.org.
- Lofton-Day C, Model F, Devos T, et al. DNA methylation biomarkers for blood-based colorectal cancer screening. Clin Chem. 2008;54:414-23.
- Grützmann R, Molnar B, Pilarsky C, et al. Sensitive Detection of Colorectal Cancer in Peripheral Blood by Septin 9 DNA Methylation Assay. PLoS ONE. 2008;3(11):e3759.
- Devos T, Tetzner R, Model F., et al Circulating Methylated Septin 9 in Plasma is a Biomarker for Colorectal Cancer. Clin Chem. 2009; (under review).
