ColoVantage® (methylated Septin 9)

Patients and Physicians: Learn more about ColoVantage

Benefits

  • ColoVantage® is a convenient blood test that aids in the detection of colorectal cancer in patients non-adherent to current testing approaches.
  • No patient preparation required before testing.

Visit our test menu to order ColoVantage (methylated Septin 9) (test code 16983)

Clinical Summary

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.

Specimen Requirements

10 mL frozen EDTA plasma (lavender-top tube); 5 mL minimum

CPT Codes*

83891, 83896 (x3), 83898 (x3), 83912

Online Resources for Healthcare Professionals

Contact a Quest Diagnostics Sales Representative, learn more about our testing services, and become a client

Quest Diagnostics - the world’s leading cancer diagnostics company

  • We offer a comprehensive oncology test menu to meet your needs and those of your patients.
    • Anatomic pathology testing for diagnosing cancer.
    • Clinical laboratory testing for screening, risk assessment, differential diagnosis, prognosis, treatment selection, therapeutic monitoring, minimal residual disease detection, and detection of recurrence.
  • Dedicated to delivering high-quality, innovative products for colorectal cancer detection.
    • ColoVantage: simple DNA blood test that aids in the detection of colorectal cancer in patients non-adherent to current testing modalities.
    • InSure#174; FITTM™ Fecal Immunochemical Test: a FDA-cleared screening test that detects bleeding in the lower gastrointestinal tract.

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.
  6. Toth PP, Armani A. Thienopyridine therapy and risk for cardiovascular events in secondary prevention. Curr Atheroscler Rep. 2009;11:364-370. .

*The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed.

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