Who Should Test?
Medical Guidelines and References
How to Order Testing For Your Patient

Who Should Test?

ColoSure™ is a non-invasive, stool DNA colorectal cancer screening test for:

• Patients age 50 years and older at average risk for colorectal cancer (CRC)
• Patients not compliant with colonoscopy or who want interim screening between colonoscopies
• Patients who do not have signs and symptoms of CRC
• High-risk patients who are noncompliant with standard screening recommendations or as interim screening between colonoscopies

Medical Guidelines and References

Guidelines:

American Cancer Society. Prevention the Focus of New Colon Cancer Screening. March 5, 2008. Available at: http://www.cancer.org/docroot/NWS/content/NWS_1_1x_Prevention_the_Focus_of_New_Colon_Cancer_Screening_Guidelines.asp

American Cancer Society. American Cancer Society Guidelines for the Early Detection of Cancer. March 5, 2008.  Available at:  http://www.cancer.org/docroot/PED/content/PED_2_3X_ACS_Cancer_Detection_Guidelines_36.asp#coloncancer

Levin B et al. 2008. Screening and surveillance for the early detection of colorectal cancer and adenomatous polyps, 2008: A joint guideline from the American Cancer Society, the US Multi-Society Task Force on Colorectal Cancer, and the American College of Radiology. CA Cancer J Clin. 58(3):130-160.

Note: Stool-based DNA screening tests, such as ColoSure™, are relatively new technologies. They have been incorporated in the American Cancer Society’s guidelines as a CRC screening option; however, the interval to repeat the test has not yet been determined.

Key References:

Ahlquist, D.A. 2002. Stool-based DNA tests for colorectal cancer: Clinical potential and early results. Reviews in Gastroenterological Disorders. 2(1): S20-S26.

American Cancer Society. Cancer Facts & Figures 2008. Atlanta, Ga: American Cancer Society; 2008. American Cancer Society. Statistics for 2008. Available at:  http://www.cancer.org/docroot/STT/STT_0.asp

Boland, C.R. 2002. Molecular basis for stool-based DNA tests for colorectal cancer: A primer for clinicians. Reviews in Gastroenterological Disorders. 2(1): S12-S19.

Fletcher, R.H. 2002. Successful colorectal cancer screening starts with primary care. Reviews in Gastroenterological Disorders. 2(1): S27-S34.

Itzkowitz, SH et al. 2007. Improved fecal DNA test for colorectal cancer screening. Clin Gastroenterol Hepatol. 5(1):111-117.

Itzkowitz, SH et al. Aug 27, 2008. A simplified non-invasive stool DNA test for colorectal cancer detection. Am J Gastroenterol.

Levin B et al. 2003. Emerging technologies in screening for colorectal cancer: CT colonographies, immunochemical fecal ooccult blood tests, and stool screening using molecular markers. CA Cancer J Clin. 53:44-55.

Ouyang DL, et al. 2005. Noninvasive testing for colorectal cancer: A review. Am J Gastroenterol. 100(6):1393-1403.

http://www.blackwell-synergy.com/doi/abs/10.1111/
j.1572-0241.2005.41427.x

Potter, J. 1999. Colorectal cancer: Molecules and populations. Journal of the National Cancer Institute 91(11):916-32.

How to Order Testing For Your Patient

Ordering stool DNA testing for your patient through DNA Direct is easy.

1. Print and complete the DNA Direct Referral Form, and fax it to 806-993-6708, Attention: Clinical Services. (Make sure your patient signs the form and checks the box authorizing DNA Direct to release test results to you.


DNA Direct Referral Form

2. DNA Direct will send a ColoSure™ collection kit directly to your patient and will coordinate all testing services. As part of the testing process, your patient is asked to create a user account with DNA Direct and answer a brief clinical questionnaire.
   
   
3. When testing is complete, as the referring physician you receive a copy of the test results and a Physician Letter, complete with test result interpretation, current medical guidelines, and scientific references. Your patient can then log on to their secure, password-protected account to learn more about their test results and receive updates on clinically relevant information.
   
   
4. You and your patients have ongoing access to support services from DNA Direct's board-certified genetics staff by phone (toll-free at 1-877-646-0222, M-F, 9-5 Pacific) and email (expert@dnadirect.com).