Colon Cancer Blood Test

ColoVantage® (Methylated Septin 9)

CPT Code(s)

81327

Methodology

Real-Time Polymerase Chain Reaction (RT-PCR)

This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Reference Range(s)

Not detected

Clinical Significance

Methylated Septin 9 is a DNA marker associated with colorectal cancer.

This is a blood test (Quest test code 16983) and no special patient preparation is required.

Expect results in 7-8 business days. 

Please read the informaiton under our  "Additional Details" tab  and consult your physician to determine if this test is suitable for you.

 

Please be advised, that our services are strictly self pay and are not eligible for submission as a claim to your health insurance provider. However, you can submit the receipt for reimbursement to many Flexible Spending and Health Savings Accounts for reimbursement.


Sample of Colon Cancer Blood Test Results

 

Informaiton from Quest Diagnostics:

Test Highlight

ColoVantage® (methylated Septin 9)

  

Clinical Use

  • Detect circulating methylated DNA from the SEPT9 gene

  • Aid in the detection of colorectal cancer (CRC) in patients non-adherent to current testing modalities

Clinical Background

Colorectal cancer (CRC) is the fourth most common cancer in the United States, however, it is the second leading cause of cancer-related deaths.1 The high number of deaths is likely due to the following facts:

  • The 5-year survival rate dramatically drops from about 90% for patients diagnosed with localized disease to 70% and 12% for those diagnosed with regional and distant stage disease, respectively.2

  • Only about 40% of patients are diagnosed at an early stage.1

  • Only about half of adults age 50 and over have been screened.3

Epigenetic changes, including methylation, play a role in the pathogenesis of CRC. Furthermore, DNA methylation occurs in the early stages of tumor development and can serve as a marker for precancerous lesions, such as adenomas. Circulating methylated DNA from the SEPT9 gene, which is involved in cytokinesis and cell cycle control, has been identified as such a marker.

The ColoVantage test detects methylated DNA from the SEPT9 gene in plasma. A case-control study performed at Quest Diagnostics showed that the ColoVantage test is 70% sensitive for CRC detection at a specificity of 89%.4 ColoVantage has successfully detected cancer at all stages; however, the number of patients at each stage of cancer was too small to derive stage-specific sensitivity data. A similar test demonstrated a sensitivity of 67% and a specificity of 88% in a prospective study of almost 8000 people.5

Current screening methods are either moderately invasive or require collection of a stool sample. Special patient preparation steps are often involved. These, among other things, may be barriers to screening.

ColoVantage represents an important medical advancement in that it is a plasma-based test that requires no patient preparation. A physician may order the ColoVantage test for screen-eligible patients who have previously avoided established colorectal cancer screening methods such as colonoscopy, fecal occult blood tests, and fecal immunochemical tests (FITs). A patient whose ColoVantage test result is positive may be at increased risk for colorectal cancer and further evaluation should be considered. ColoVantage is not a replacement test for colonoscopy.

Method

  • Real-time polymerase chain reaction (PCR)-based measurement of methylated SEPT9 DNA

  • Alias: methylated septin 9 DNA, methylated SEPT9 DNA

Interpretive Information

A patient whose ColoVantage test result is positive may be at increased risk for colorectal cancer and further evaluation should be considered.

References

  1. American Cancer Society. Statistics for 2012. American Cancer Society Web site. Available at: http://www.cancer.org/Research/CancerFactsFigures/index. Accessed October 3, 2012.

  2. Howlader N, Noone AM, Krapcho M, et al (eds). SEER Cancer Statistics Review, 1975-2009. National Cancer Institute SEER Web site. Available at: http://www.seer.cancer.gov/statfacts/html/colorect.html. Updated November 2011. Accessed October 3, 2012.

  3. Shapiro JA, Seeff LC, Thompson TD, et al. Colorectal cancer test use from the 2005 national health interview survey. Cancer Epidemiol Biomarkers Prev. 2008;17:1623-1630.

  4. Data on file at Quest Diagnostics.

  5. Rösch T, Church T, Osborn N, et al. Prospective clinical validation of an assay for methylated SEPT9 DNA for colorectal cancer screening in plasma of average risk men and women over the age of 50 [abstract]. Gut. 2010;59(suppl III):A307.

This test was developed and performance characteristics have been determined by Quest Diagnostics Nichols Institute. Performance characteristics refer to the analytical performance of the test.

Polymerase chain reaction (PCR) is performed pursuant to a license agreement with Roche Molecular Systems, Inc.

 

Content reviewed 05/2013

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