A highly-sensitive screening and monitoring test
Indication
Diagnosis of colorectal cancer
Partner
PreMD Inc.
Diagnostic - Colopath®/ColorectAlert™
Colopath®/ColorectAlert™ is a highly sensitive and minimally invasive screening and monitoring test for colorectal cancer. Colopath® screens for a phospholipid analyte (plasmalogen) in rectal mucus of individuals with colorectal pathology, whereas ColorectAlert™ screens for the T-antigen, a complex sugar in rectal mucus. The Colopath®/ColorectAlert™ test involves the application of a rectal mucus sample to a test strip and a positive/negative result is based on a Schiff’s aldehyde reaction.
Histological examination of colon biopsies by Ambrilia researchers has revealed that the colonic lining of Colopath®/ColorectAlert™-positive individuals may have an abnormal appearance characterized by certain cells which have become distended and swollen. This abnormal appearance may be characteristic of a colon which is pre-disposed toward pathological changes. Increased monitoring of Colopath®/ColorectAlert™-positive individuals may, therefore, allow earlier detection of colorectal cancer. Early detection is a key to reducing mortality from colorectal cancer.
In July 2003, Ambrilia announced its shared enthusiasm with licensee partner, PreMD Inc. on the Colopath®/ColorectAlert™ study results presented at the 94th Annual Meeting of the American Association for Cancer Research. Results from three studies totaling 1,787 subjects show that Colopath®/ColorectAlert™ detects 54% of early-stage colorectal cancers and 49% of all cancers. Subjects who had a positive Colopath®/ColorectAlert™ test were 3.5 times more likely to have cancer than subjects who had a negative test result. An additional finding in the study was the powerful effect of combining two screening tests - Colopath®/ColorectAlert™ and fecal occult blood test, which is widely available. In combination with FOBT it is found that over 99% of patients who are negative for both tests have no incidence of cancer.
Further clinical studies to evaluate the applicability of Colopath®/ColorectAlert™ to low-risk population; a multi center study with the U.S. National Cancer Institute's (NCI) Early Detection Research Network's (EDRN) and the Great Lakes-New England Clinical Epidemiology Center Consortium (GLNE CEC Consortium) is underway. It is estimated that approximately 600 patients will be enrolled in this study. Plans are to prepare for a 510K or PMA application with the FDA within the next 12 to 24 months.