Test Code: 904413


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 91% for patients diagnosed with early stage disease to 70% and 11% 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.1

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 banners to screening.

ColoVantage, a plasma-based test that requires no patient preparation, is now available. ColoVantage detects circulating methylated DNA from the SEPT9 gene which is involved in cytokenesis and cell cycle control. Early case-control studies show that presence of methylated SEPT9 DNA in plasma is 58% to 69% sensitive for CRC detection at a specificity of 86% to 90%.3-5 Although the ColoVantage test has yet to be clinically validated as a screening test, a physician may order the 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.


Specimen Requirements

10 mL of frozen EDTA plasma from lavender-top tubes (5.0 mL minimum). Samples with less than 5.0 mL of plasma will be rejected.

To obtain this volume of plasma, collect blood in two 10 mL EDTA lavender-top tubes or five standard 4 mL EDTA lavender-top tubes. Centrifuge the blood samples and aliquot plasma in a single 10 mL transfer tube or two 5 mL transfer tubes and freeze.


CPT Codes*

83891 (x4); 83896 (x4); 83898 (x4); 83912


Methodology

Real-Time Polymerase Chain Reaction (RT-PCR)


References

  1. American Cancer Society. Statistics for 2009. American Cancer Society Web site. http://www.cancer.org/docroot/STT/stt_0.asp. Accessed October 29, 2009.
  2. Horner MJ, Ries LAG, Krapcho M, et al (eds). SEER Cancer Statistics Review, 1975-2006. National Cancer Institute SEER Web site. http://seer.cancer.gov/csr/1975_2006/index.html. Updated May 2009. Accessed October 30, 2009.
  3. Lofton-Day C, Model F, DeVos T, et al. DNA methylation biomarkers for blood-based colorectal cancer screening. Clin Chem. 2008;54:414-423.
  4. 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:e3759. Doi:10.1371/journal.pone.0003759.
  5. deVos T, Tetzner R, Model F, et al. Circulating methylated SEPT9 DNA in plasma is a biomarker for colorectal cancer. Clin Chem. 2009;55:1337-1346.

*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.

Sonora Quest Laboratories, the associated logo and marks are the registered trademarks of Sonora Quest Laboratories. All third party marks — '©' and '™' — are the property of their respective owners. © 2011 Sonora Quest Laboratories. All rights reserved.

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