Test Center

My Recent Searches

  • No Recent Search.

My Tests Viewed

  • No Test Viewed.

ColoVantage (methylated Septin 9)

ColoVantage (methylated Septin 9)

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 early stage 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

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. It detects circulating methylated DNA from the SEPT9 gene, which is involved in cytokinesis and cell cycle control. 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

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 2010. American Cancer Society Web site. http://www.cancer.org/Research/CancerFactsFigures/index. Accessed December 7, 2010.

  2. Altekruse SF, Kosary CL,, Krapcho M, et al (eds). SEER Cancer Statistics Review, 1975-2007. National Cancer Institute SEER Web site. http://seer.cancer.gov/csr/1975_2007/sections.html. Updated June 30, 2010. Accessed January 3, 2011.

  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 12/2011
 
top of page

* The tests listed by specialist are a select group of tests offered. For a complete list of Quest Diagnostics tests, please refer to our Directory of Services.