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EDP Biotech Debuts CA1-18 Tumor Marker Assay for Early Stage Colorectal Cancer |
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14 Oct 2006 |
Today announced the development of the CA1-18 Enzyme Immunoassay (EIA) to be used as an aid in the diagnosis and management of the colorectal cancer patient.
KNOXVILLE, TN, USA | Oct 13, 2006 | EDP Biotech Corporation (EDP), a diagnostics company focused on the development and sale of immunodiagnostic tests for humans, today announced the development of the CA1-18 Enzyme Immunoassay (EIA) to be used as an aid in the diagnosis and management of the colorectal cancer patient.
The CA1-18 test is a monoclonal-polyclonal sandwich EIA for the quantitative measurement of CA1-18 (Tennessee Antigen) in human serum. Tennessee Antigen, a tumor-associated antigen, is present in elevated levels in the serum of patients with various carcinomas, particularly colorectal cancer.
The CA1-18 EIA will have the greatest impact on patients already diagnosed with cancer, but further studies may show that the test has enough sensitivity and specificity to serve as a screening test, according to Dr. John Costanzi, medical director of EDP.
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"There's a group of blood tests called tumor markers," Costanzi said. "The CA1-18 test looks much more sensitive than most of the ones we have for colon cancer."
The CA1-18 Tumor Marker has been evaluated by 18 clinical investigators and proven to be 96% accurate in detecting the presence of colorectal cancer in its early stages. These investigations were conducted over a period of more than 20 years in 18 different locations, including Memorial Sloan-Kettering Cancer Center.
Now available to research customers, EDP plans to submit the CA1-18 EIA to the U.S. Food and Drug Administration (FDA) for marketing clearance in April 2007.
About colon cancer
According to the American Cancer Society, colorectal cancer is the third most commonly diagnosed cancer in North America and it is the second most common cause of death. This relatively high mortality rate is due in part to the lack of accurate screening tests for disease in its early stages. In addition, the American Cancer Society estimates that there will be about 148,610 new cases of colorectal cancer in 2006 in the United States and 55,170 deaths as a result of the disease.
Early-stage colorectal cancer is not usually associated with symptoms. In about 60% of all cases, the disease has spread beyond the colon or rectum at the time of diagnosis. According to the American Cancer Society, only 39% of colorectal cancers identified are detected at an early, localized stage. When detected at that early stage the survival rate for patients is greatly improved.
About EDP Biotech Corporation
EDP is a diagnostics company, headquartered in Knoxville, Tenn., focused on the development and sale of immunodiagnostic assays for the early detection, prognosis and monitoring of cancer patients.
SOURCE: EDP Biotech Corporation |
