CC Detect - Serum-Based Diagnostic Test For Colon Cancer Available

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CC Detect, Panacea Pharmaceuticals's serum- based colon cancer diagnostic test, is now available from Panacea Laboratories. CC Detect is a simple blood test that should facilitate the identification of individuals with cancer of the colon and rectum when used in conjunction with standard screening methods. Panacea Laboratories, a division of Panacea Pharmaceuticals, is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). The blood sample can be ordered by any physician and sent to Panacea for testing.

Colorectal cancer -- cancer of the colon or rectum -- is the third most common type of cancer diagnosed in the US. 153,760 new colorectal cancer cases and 52,180 deaths due to colorectal cancer are expected in 2007. In an effort to detect colorectal cancer in its earliest stages, The American Cancer Society (ACS) and similar organizations have published guidelines for colorectal screening. It is recommended that most people begin colorectal screening at age 50 and that this screening be repeated at specific time intervals. Approximately, 5-10% of all colorectal cancers occur in people who are at "high risk," defined as much greater than twice the average risk. An additional 15-20% of colorectal cancers occur in people at "increased risk," defined as approximately twice average risk. It is recommended that people at high and increased risk for colorectal cancer begin screening at a younger age and have screening repeated more frequently.

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Factors associated with an increased or high risk of colorectal cancer can be divided into two categories: personal, and hereditary or familial. Personal risk factors include: a history of colorectal cancer that has been completely removed and, to a lesser extent, a history of ovarian, uterine or breast cancer; a history of polyps, especially large adenomatous polyps; a history of inflammatory bowel disease, particularly ulcerative colitis and Crohn's disease; a high fat, low-fiber diet; a sedentary life-style; obesity; cigarette smoking, both currently and in the past; heavy alcohol use; and diabetes. Other possible personal risk factors for colorectal cancer include a history of working the night-shift several nights a week for at least 15 years and previous radiation treatment for prostate cancer. Familial and hereditary risk factors include: having a close relative who had colorectal cancer before age 60; family history of polyposis syndromes and hereditary non-polyposis syndromes; African-American background; and Ashkenazi Jewish background. Frequent testing with colonoscopy, sigmoidoscopy, double contrast barium enemas and fecal occult blood tests are performed in these high-and increased risk populations. The age at which this intensive screening should begin depends on the actual risk factors. For example, it should begin at puberty for those with a history of familial adenomatous polyposis, at 12 -15 years after the onset of left- sided inflammatory bowel disease and, if an immediate relative has had colorectal cancer, at 10 years before the age that the relative was diagnosed.

Failure to diagnose colorectal cancer before it has spread can have disastrous consequences. The 5 year relative survival rates are 89.8% for localized disease, 67.7% for regional disease, and 10.3% for metastatic disease. Even persons who know that they are at high risk and increased risk for colorectal cancer, however, are often non-compliant or poorly compliant with screening recommendations because they perceive the tests to be embarrassing, unpleasant and time-consuming. In addition, many people who are at higher-than-average risk do not know that they are particularly at risk nor do their physicians always inform them of their risk. Furthermore, each test has its drawbacks in terms of sensitivity and specificity, and some tests are associated with potential complications.

CC Detect measures levels of human aspartyl (asparaginyl) beta-hydroxylase (HAAH), a cancer molecular marker, in blood. HAAH has been detected by immunohistochemical staining (IHC) in a broad range of cancers including colon cancer. In addition, HAAH protein levels in serum have been demonstrated to be highly sensitive and specific for cancer in hundreds of patients with a range of cancer types, including colon cancer. Increased levels of HAAH have been found in the serum of 99% of individuals with colorectal cancer (n=145). In individuals not known to have cancer, HAAH was essentially undetectable in serum. HAAH was elevated in serum from individuals with all stages of colorectal cancer; mean serum HAAH levels for stages I - IV were 33, 29, 24 and 34 ng/ml, respectively.

"CC Detect provides information to differentiate individuals who have colorectal cancer from those who do not have cancer; it should be performed in individuals at increased and high risk as per the ACS recommendations for their particular risk factors," commented Pamela Jo Harris, MD, Vice President, Medical and Clinical Affairs at Panacea. "An elevated HAAH value should be interpreted by the physician in conjunction with a physical exam and the results of the screening tests recommended by the ACS, which should facilitate earlier identification of recurrent disease and prompt initiation of appropriate therapy. Detection and prompt treatment of early colorectal cancer is likely to result in improved outcomes and fewer deaths attributable to the disease."

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