• Colorectal cancer is the third most common cancer in the U.S
  • It is the 2nd leading cause of cancer related deaths
  • American Cancer Society (ACS) recommends that adults aged 45–75 years undergo screening.
  • 20% higher incidence in Black persons rather than white, with fatality rate 40% higher in blacks.

What is Colorectal Cancer?

  • Most colorectal cancers (CRC) begin as a growth, or lesion, in the tissue that lines the inner surface of the colon or rectum.
  • Lesions may appear as raised polyps, (a growth that protrudes from a mucous membrane) that may be attached to the inner surface of the colon or rectum with or without a stalk.
  • Colorectal polyps are common in people older than 50 years of age, and most do not become cancer. However, a certain type of polyp known as an adenoma (tumor) most likely to become a cancer.
  • Most CRCs develop from adenomas, among which “advanced” adenomas are considered to be the clinically relevant precursors of CRC. 

Synergy between FIT Tests & DiaCarta’s ColoscapeTM

Current Screening Requirements for Colorectal Cancer:

  • The American Cancer Society recommends that people at average risk of colorectal cancer start regular screening at age 45. 
  • The U.S. Preventive Services Task Force (USPSTF) states that adults aged 45 to 75 should be screened for colorectal cancer. 
  • The Task Force recommends that adults ages 76 to 85 ask their doctor if they should be screened.

FIT (Fecal immunochemical test)

FIT test is used to detect blood in stool that cannot be seen with the naked eye using stool sample. A FIT test is often used to detect bleeding in the digestive tract. A FIT test may not detect blood from further up the digestive tract (such as the stomach), which means it is more specific to finding bleeding from the lower gastrointestinal tract and blood in the stool could be the first sign of colorectal cancer or advanced adenomas (pre-cancerous lesions)

FIT test

  • Easy to do
  • Low cost test
  • Specific for CRC

Challenges with the FIT test

Whereas the FIT test is approved by the FDA as a screening test, the challenge is to diagnose lesions before they become cancer. For advanced adenomas, FIT was less sensitive, yielding a sensitivity of only 40%
Ann Intern Med 2019 Mar 5;170(5):319-329, doi: 10.7326/M18-2390

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COLOSCAPETM Colorectal Cancer Mutation Detection Test

Blood (plasma) based test used to detect genetic mutations associated with colorectal cancer

  • Convenient sample (Blood)
  • 100% specific 
  • Sensitivity 62% for Advanced adenomas
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The Synergy – DiaCarta’s ColoScapeTM and the FIT test

  • Perform this FIT test (which simple and a non-invasive tool) for screening of Colorectal cancer
  • If FIT test result is Positive, the physician can order ColoscapeTM which will test and screen for the presence of genetic mutations associated with colorectal cancer or advanced adenomas using ColoscapeTM
  • If the FIT test is Negative then it is recommended to repeat the FIT test annually, although a negative FIT Test does not rule out colorectal cancer.
  • If ColoscapeTM test is Positive, then the patient needs to seek physician advice to perform Colonoscopy for direct visualization of the gastrointestinal tract or other methods to confirm the diagnosis.
  • If ColoscapeTM test is Negative, then depending on the presentation of the patient, risk factor, medical and family history, the physician will weigh the risk and benefit of other tests to confirm or rule out the disease.